It is critical that applicants follow the Research (R) 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. Applications that do not comply with these instructions may be delayed or not accepted for review.

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.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348.

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

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



Table of Contents

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

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


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

Despite many technological and work environment advances, mining remains one of the most challenging and demanding occupations in the United States. In 2021, the fatality mining rate of 16.15 is nearly four times the rate for all industries as reported by the U.S. Bureau of Labor Statistics (LS).

Intelligent mining technologies include automation, robotics and other emerging and enabling technologies that support intelligent technologies. Mining companies across the globe have been implementing autonomous and semi-autonomous equipment including surface haulage trucks, blast hole drill rigs, and dozers; as well as underground loaders, trucks, and drills in metal and non-metal mines, and automated longwalls in underground coal mines.

Robotics efforts have included mine rescue and hazardous environment surveillance and monitoring. These trends towards more automation are expected to increase. While the overall impact of increased intelligent mining systems is likely to be a reduction in exposure to safety and health risks, autonomous equipment, including robotics, are currently being integrated into existing systems without a complete understanding of the potential impact on the humans in the system or interoperability.

It is important to determine how these technologies will affect other components of the mining system as well as change the way workers interact in the system or perform their jobs.

Injuries associated with automated systems are not easily identified in the US due to coding requirements for injuries and because there is not a prevalence of automated systems in the US.
Two data sources, one from the Western Australia Department of Mines, Industry Regulation and Safety and the MSHA Injury Database (2010-2020), had sufficient detail in the incident descriptions to make a connection to automation and/or emerging technology.

The Australia data described 82 incidents involving automation between 2010 and 2020. The incidents were then categorized further to define the types of automation problems that were being experienced. Namely, the categories included human error during remote operations, human error during autonomous operations, programming errors, mechanical failure, loss of traction, loss of controls (mechanical and electronic), maintenance error, lightning strike, and shifting loads [Haight, J., Burgess-Limerick, R., (2021) A Global Perspective on Automation Experience in Mining An Assessment of the Automation Impact on Worker Safety and Health, Report 1, BAA 75D301-20-R-67845. ]

Seventy-six MSHA records in the same eleven-year period showed a connection to automation and six showed a connection to robotics in the incident descriptions. In addition, NIOSH researchers identified 61 robot-related deaths in mining and non-mining industries between 1992 and 2015 from the Bureau of Labor Statistics (BLS) Census of Fatal Occupational Injuries (CFOI) research database.

These fatalities will likely increase over time because of the increasing number of conventional industrial robots being used by companies in the U.S., and from the introduction of collaborative and co-existing robots, powered exoskeletons, and autonomous vehicles into the work environment.

Purpose

The purpose is to develop and conduct research initiatives in automation, robotics and intelligent mining systems to improve workplace safety and health in U.S. mining operations and that can contribute to the goal of completely eliminating mining fatalities within the next two decades.

A key factor of this announcement is the Congressional restriction placed on the funding which limits applications to U.S. universities with formal graduate degree programs in both mining and explosives engineering.

Approach

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. Unveiled in 1996, NORA entered its third decade (2016-2026) with an enhanced structure. It now consists of ten industry sectors based on major areas of the U.S. economy, and seven health and safety cross-sectors organized according to the major health and safety issues affecting the U.S. working population. The national agenda is developed and implemented through the NORA Sector and Cross-Sector Councils. Each council develops and maintains an Agenda for its sector or cross-sector. The collection of agendas comprises the agenda for the nation for improvements in occupational safety and health. The agenda also provides a vehicle for stakeholders to describe the most relevant safety and health issues, research gaps, and needs.

Protecting the health and safety of mine workers by preventing diseases, injuries, and fatalities is a NIOSH priority, along with making certain that workers are qualified, trained, and properly equipped. The NORA Mining Agenda was developed and implemented through NORA Sector Councils and is guidance for the nation as a whole, while the 2019-2023 Mining Program Strategic Plan is specific to NIOSH and its capabilities and resources.



The NIOSH Mining Program has established three overarching strategic goals for this plan:

Strategic Goal 1: Reduce mine workers risk of occupational illness

Strategic Goal 2: Reduce mine workers risk of traumatic injuries and fatalities

Strategic Goal 3: Reduce the risk of mine disasters and improve post-disaster survivability of mine workers.

This is a collaborative grant and applicants should outline their expected interactions with NIOSH researchers and subject matter experts.

Objectives

The objective of this cooperative agreement is to address research initiatives in automation, robotics, and intelligent mining systems to improve workplace safety and health in U.S. mining operations.

The impact of research conducted by recipients should focus on advances in assured autonomy, i.e., assuring autonomous mining equipment and robotics achieve improved workplace safety and health for mine workers while meeting efficiency and productivity goals.

Interactions with mining stakeholders have shown that the U.S. industry is lagging behind other parts of the world in the implementation of automation technologies due to a lack of guidance in implementing new technology, questions about technology readiness, a lack of guidance and tools for effectively dealing with the migration from human-operated equipment to autonomous equipment, and concerns about the potential unsafe interactions between autonomous equipment and workers. Impacts could include but are not limited to:

• Advances in and implementation of human-centered design principles for automated equipment and the systems used to monitor or interact with them.
• New methods, guidance, and best practices in change management, training/retraining workers, technology integration, and safety evaluation.
• New methods and evaluation techniques for safe design that consider the entire mining operation as a system.
• Advances and availability of enabling technologies for assured autonomy including sensors, data fusion and processing, artificial intelligence, and systems for improved machine and operator situational awareness.
• Availability of new miner rescue and post-disaster surveillance technologies.

Applicants are encouraged to consider those aspects of their graduate degree program in mining and explosives engineering, including unique facilities, that could best support their proposed research related to automation, robotics, and intelligent mining systems.

Clearly state your proposed goals and objectives, and directly link these to the occupational health and safety burdens you are addressing.

Provide data to support your selection of the proposed work, such as morbidity or mortality rates and 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, provide qualitative data that describe exposures, the magnitude of the problem, and potential benefits and impacts of addressing the issue. Qualitative data may be necessary when the nature of the exposure or population at risk makes it difficult to collect large-scale, representative quantitative data.

NORA Sectors and Health and Safety Cross-sectors

Provide a statement about which NORA sector(s) and cross-sector(s) and which NIOSH strategic and intermediate goals are being addressed. Provide a rationale for how the proposed research will contribute to the specified priority area(s). Explain how the proposed research will contribute to the NIOSH Research to Practice (r2p) initiative and state the expected Outcomes and Outputs (see Approach). Place this information in both the Project Abstract and in the Research Strategy (Significance) sections of the application.

Healthy People 2030 and other National Strategic Priorities

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

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

The Healthy People 2030 occupational safety and health objectives aim to prevent illness, injury, and disease due to working conditions. All objectives, core and developmental, align with NIOSH’s strategic plan and are addressed through the National Occupational Research Agenda (NORA). NORA is a program established by NIOSH that works with partners from academia, industry, labor, and government to stimulate research and improve workplace practices.

Public Health Impact

Robotic and intelligent mining technology and workplace safety research will support the mission of NIOSH in protecting and promoting the safety and health of mining workers in the United States.

Relevant Work

NIOSH has an extensive history of conducting research to understand and to reduce hazards in the mining industry. To learn more about NIOSH's work in the mining safety and health, visit https://www.cdc.gov/niosh/mining/researchprogram/index.html.

Robotic and intelligent mining technology and workplace safety research developments could be utilized to enhance mine safety and accident response.

Target Population

The beneficiaries of these cooperative agreements are miners working in the United States. As appropriate, the research project might target vulnerable U.S. worker populations to address increased safety and health risks associated with occupational health disparities, changing worker demographics, and the changing nature of work.

Diversity, Equity, and Inclusion

In June 2019, NIOSH began an initiative to take substantive action in creating greater diversity, equity, and inclusion in its workforce, the workplace and in its service to the public. This initiative led to the establishment of the NIOSH Diversity and Inclusion Office. The associated strategic plan is intended to guide actions that specifically address diversity, equity, and inclusion (DEI) in all aspects of NIOSH's work, including NIOSH-supported extramural programs. Applicants should demonstrate a commitment to DEI in all aspects of their proposed research project (including partnerships, outputs, and outcomes) in the Research Strategy section of the application.

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 mining 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.

Collaborations/Partnerships

Partnerships are important for the NIOSH Mining Safety and Health Program. They facilitate advances in the safety and health of U.S. mine workers. Input from customers and stakeholder groups, which have inherent knowledge and concern about the safety and health of miners, helps in setting research priorities. Partners often add expertise or specialized experience to the research team, which contributes to the success of the overall project.

The NIOSH broad base of stakeholders includes academia; equipment manufacturers; government; mine operators; mining industry trade associations; organized labor; regulatory agencies (on the local, state, and federal levels); research laboratories; and suppliers. NIOSH collaborates and communicates with the stakeholders on a regular basis to better inform their research and assess its direct contributions to safety and health.

Applicants will institute collaborative partnerships as appropriate with local and state organizations, universities, manufacturers, government agencies, professional organizations, engineering and safety training partner organizations, community organizations, health care institutions, business groups, and labor organizations, in addition to NIOSH, to carry out these proposed research activities.

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

Note to Applicants

Include collaborations or partnerships, particularly with industrial collaborators/partners as well as NIOSH, that strengthen the proposed research in terms of occupational, safety and health (OSH), or related, expertise and resources.

Evaluation/Performance Measurement

Evaluations provide information for management and improve program effectiveness. The following CDC document A Framework for Program Evaluation may be helpful. Effective program evaluation is a systematic way to improve and account for public safety and 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 safety and health strategies, improving existing programs including evidence-based activities, and demonstrating beneficial results and impact of federal funding.

Translation Plan

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

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

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

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

Note to Applicants

Applicants must provide a brief statement about how their proposed research addresses r2p in both the Description (Abstract) and in the Research Strategy (Significance). Describe the anticipated strategies for translation and/or dissemination of research findings, including the audiences to be reached and the methods to reach those audiences.

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

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New - An application that is submitted for funding for the first time. Resubmission - An unfunded application that has been modified following initial review and resubmitted for new consideration.

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

NIOSH intends to commit approximately $8,000,000 in total costs (direct and indirect) over the entire project period (up to 4 years) contingent on adequate annual appropriations.

Estimated total funding (direct and indirect costs) in FY 2023 for a single 12-month budget period is $2,000,000 per award.

Future year amounts will depend on annual appropriations.

NIOSH intends to commit $2,000,000 in FY 2023 to fund 1 award.

Anticipated number of awards per year: 1.

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

Because the nature and scope of the proposed research topics, delivery types and locations will vary from application to application, it is also anticipated that costs and duration of each award may also vary.

Award Budget

CDC/NIOSH intends to commit $2,000,000 per award Total Costs (direct and indirect costs) per budget period.

Award Ceiling: $2,000,000 Total costs (direct and indirect) per budget period, per award

Award Floor: $1,600,000 Total costs (direct and indirect) per budget period, per award

NIOSH intends to commit up to approximately $2,000,000 in total costs (direct and indirect) to fund 1 cooperative agreement for each 12-month budget period.

Critical Budget Requirement: Total costs for all subaward/consortium budgets must be counted as Direct Costs.

Award Project Period

4 years

The total project period for an application submitted in response to this funding opportunity may not exceed 4 years.

Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interests of the federal government.

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

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
Eligible Organizations

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education


The following types of Higher Education Institutions are always encouraged to apply for 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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• 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
Foreign Institutions

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

Responsiveness

If an applicant exceeds the four-year period of performance limit or the total cost limit of $2,000,000 (direct and indirect) for each 12-month budget period, CDC/NIOSH will consider the application non-responsive and will notify the applicant that the application did not meet the submission requirements.

A key factor of this announcement is the Congressional restriction placed on the funding which limits applications to U.S.-based programs that have formal graduate degree programs in both mining and explosives engineering.

Documentation of formal graduate degree programs in both mining and explosives engineering must be submitted by potential applicants to establish eligibility.

The PI must be employed by an academic department that offers graduate degree programs in both mining and explosives engineering. Enough detail must be provided in the proposal to clearly demonstrate the department meets all these criteria.

Upon receipt, applications will be evaluated for completeness by CDC/NIOSH.

CDC/NIOSH will review all applications for responsiveness. Incomplete and/or non-responsive applications will not be reviewed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Unique Entity Identifier (UEI) number in order to begin each of the following registrations. All registrations must be successfully completed and active prior to the application due date. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

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.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The one-time registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks. 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. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. 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.

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.

Eligible Individuals (Program Director/Principal Investigator) in Organizations/Institutions

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for CDC/NIOSH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

When multiple PDs/PIs are proposed, NIOSH requires one PD/PI to be designated as the "Contact" PI, who will be responsible for all communications between the PDs/PIs and the NIOSH, for assembling the application materials outlined below, and for coordinating progress reports. The Contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs.

The Principal Investigator (PI) must hold a full-time academic position at the rank of Assistant Professor or higher at an academic institution within the U.S.

The PI must be employed by an academic department that offers graduate degree programs in both mining and explosives engineering. Enough detail must be provided in the proposal to clearly demonstrate the department meets all these criteria.

NOTE: The CDC does not make awards to individuals directly.

2. Cost Sharing

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

3. Additional Information on Eligibility

In accordance the Division H Departments of Labor, Health and Human Services, and Education, and related Agencies Appropriations Act, 2023 applicants must be a United States academic institution that offers graduate degree programs in both mining and explosives engineering.

The documentation of an academic accredited institution with graduate degree programs in both mining and explosives engineering must be submitted with the application to support an eligibility determination.

Number of Applications: Only one application per institution (normally identified by having UEI number) is allowed.

The NOFO governs New and Resubmission applications.

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

If your application is incomplete or non-responsive to the eligibility criteria listed in this section, it will not enter the review process.

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


Application guides 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 FOA 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 FOA. Follow the instructions in the SF-424 (R&R) Application Guide to ensure you complete all appropriate optional components.

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the FOA by selecting the Add Optional Form button in the left navigation panel.

Letter of Intent

Due Date for Letter of Intent: 3/28/2023

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

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

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

The letter of intent should be sent to:

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

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following exceptions or additional requirements for this specific FOA:

• The Research Strategy component of the Research Plan is limited to 12 pages. These page limits are the totals for all text, tables, graphs, figures, diagrams, and charts in this component.
• Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files, or 100 pages for all appendices.

Pages that exceed page limits described in this FOA will be removed and not forwarded for peer review.

Instructions for Application Submission

A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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.

Required Components for this FOA

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed. For this FOA, CDC/NIOSH requires a detailed budget for the initial budget year and a budget for each consecutive year of support. Modular budgets are not allowed.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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 (FOAs). 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 (R&R) unless otherwise specified in this FOA. As applicable to and specified in this FOA, 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:

Research Plan Section

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 FOA.

2. Specific Aims state the problem the proposed research addresses and how it will result in public safety and health impacts and improvements in population safety and 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 timeline.

4. Progress Report Publication List (for Renewals only)

Other Research Plan Section

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

Only limited Appendix materials are allowed. 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.

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 FOA.

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
• 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 .



PHS Human Subjects and Clinical Trials Information

Note: The Revised Common Rule defined clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Including behavioral health-related outcomes recognized that clinical trials may occur outside a biomedical context.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

Optional Components for this FOA

R&R Subaward Budget

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

PHS Assignment Request Form

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

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are strongly encouraged to allocate additional time and submit in advance of the deadline to ensure they have time to make any corrections that might be necessary for successful submission. This includes the time necessary to complete the application resubmission process that may be necessary, if errors are identified during validation by Grants.gov and the NIH eRA systems. The application package is not complete until it has passed the Grants.gov and NIH eRA Commons submission and validation processes. Applicants will use a platform or system to submit applications.

When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission. If ASSIST detects errors, then the applicant must correct errors before their application can be submitted. Applicants should view their applications in ASSIST after submission to ensure accurate and successful submission through Grants.gov. If the submission is not successful and post-submission errors are found, then those errors must be corrected, and the application must be resubmitted in ASSIST.

Applicants are able to access, view, and track the status of their applications in the eRA Commons.

Information on the submission process is provided in the SF-424 (R&R) Application Guidance and ASSIST User Guide.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the grant application due date and 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). Errors must be corrected, and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants who encounter problems when submitting their applications must attempt to resolve them by contacting the NIH eRA Service desk at:
Toll-free: 1-866-504-9552; Phone: 301-402-7469
http://grants.nih.gov/support/index.html
Hours: Mon-Fri, 7 a.m. to 8 p.m. Eastern Time (closed on Federal holidays)

Problems with Grants.gov can be resolved by contacting the Grants.gov Contact Center at:

Toll-free: 1-800-518-4726
https://www.grants.gov/web/grants/support.html
support@grants.gov
Hours: 24 hours a day, 7 days a week; closed on Federal holidays

It is important that applicants complete the application submission process well in advance of the due date time.

After submission of your application package, applicants will receive a "submission receipt" email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. A third and final e-mail message is generated once the applicant's application package has passed validation and the grantor agency has confirmed receipt of the application.

Unsuccessful Submissions: If an application submission was unsuccessful, the applicant must:

1. Track submission and verify the submission status (tracking should be done initially regardless of rejection or success).

a. If the status states "rejected," be sure to save time stamped, documented rejection notices, and do #2a or #2b


2. Check emails from both Grants.gov and NIH eRA Commons for rejection notices.

a. If the deadline has passed, he/she should email the Grants Management contact listed in the

Agency Contacts section of this announcement explaining why the submission failed.

b. If there is time before the deadline, correct the problem(s) and resubmit as soon as possible.

Electronically submitted applications must be submitted no later than 11:59PM Eastern Time, on the listed application due date.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

Expanded Authority:

The recipient is permitted expanded authorities in the administration of the award.

For more information on expanded authority and pre-award costs, go to the HHS Grants Policy Statement and speak to your Grants Management Specialist.

All CDC/NIOSH 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.

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, and embargo issues).

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

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, recipients 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 FOA.

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.

Awards may be initially issued with restrictions until all information requested can be provided. Generally, funds will not be given for renovation of existing facilities or for purchasing substantial amounts of equipment.

7. 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 Questionnaire within the past 12 months of the closing date of this FOA, then you must submit a copy of that questionnaire, or submit a letter signed by the authorized organization representative to include the original submission date, organization’s EIN and 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. Upload the questionnaire and supporting documents as an attachment in the "12. Other Attachments" section of the "R&R Other Project Information" section of the application.

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."

Application Submission

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

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

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

Important reminders:

All Senior/Key Personnel, including any PD(s)/PI(s), must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to CDC/NIOSH. See Section III of this FOA for information on registration requirements.

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 appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject-related policies described in Part II of the SF 424 (R&R) Application Guide and in the HHS Grants Policy Statement.

See more tips for avoiding common errors and submitting, tracking, and viewing applications:

• https://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm
• https://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm
• https://era.nih.gov/files/ASSIST_user_guide.pdf
• http://era.nih.gov/erahelp/ASSIST/

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the CDC Office of Grants Services (OGS) and responsiveness by OGS and NIOSH. Applications that are incomplete or non-compliant will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Does the project address a significant health and safety issue in the industry with potential contribution and relevance to the NIOSH Mining Program mission? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or field 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 applicant describe the following?

• Outcomes and impacts achieved
• The institution’s capacity in mining safety and health research.
• The planned external collaborations with NIOSH researchers.
• The planned external collaborations with industry stakeholders, including, if applicable to the proposed work, other internal and external university programs.
• The value brought to the project through the dual graduate degree programs in mining and explosives engineering, including the number of graduate students to be involved at the masters and doctoral levels.
Investigator(s)

Are the program directors (PD)/principal investigators (PI), 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? Do the investigators have a successful track record in mining health and safety research? Is there evidence of past collaborations with the proposed research team? Have previous research results provided high-quality outputs and contributed to improvements in mining health and safety practices and population health? Is the collaboration of the project team with the mining industry and NIOSH adequate for achieving the proposed work?

Innovation

If the project involves human subject research, are there plans for (1) the protection of human subjects from research risks, and (2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Do the investigators understand past work in the field and the barriers to potential implementation or commercialization? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects, if applicable?

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?
For planned or potential collaborations, is the commitment and cooperation of other interested parties adequate as evidenced by letters of support specifying the nature and extent of their involvement? Does the program have the capacity to successfully complete the project?

Additional Review Criteria

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

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the 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 Guidelines for the Review of Human Subjects or HHS/CDC Requirements under AR-1 Human Subjects Requirements.

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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



Dual Use Research of Concern

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

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

Additional Review Considerations

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

Applications from Foreign Organizations

Not applicable.

Select Agent Research

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

Resource Sharing Plans

HHS/CDC policy requires that recipients of grant awards make research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. Please see AR-25.

The reasonableness of the resource sharing plan, or the rationale for not sharing research data, will be assessed by the reviewers. The reviewers will not, however, factor the proposed plan into the determination of scientific merit or the impact score.

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

Investigators responding to this Funding Opportunity Announcement 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). Other examples of DMPs may be found at USGS.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
The applicant can obtain budget preparation guidance for completing a detailed justified budget on the CDC website, at the following Internet address: https://www.cdc.gov/grants/applying/application-resources.html .Following this guidance will also facilitate the review and approval of the budget request of applications selected for award.

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.

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

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

Applications will be assigned to the National Institute for Occupational Safety and Health. Applications will compete for available funds with all other recommended applications submitted in response to this FOA.

Following initial peer review, recommended applications will receive a second level of review for programmatic relevance and priority. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review
• Relevance of the proposed project to the NIOSH Mining Program
• Proposed or current strength of partnerships (and delivery capacity potential) with NIOSH programs (commensurate with a cooperative agreement) and other agencies, in terms of likelihood of new synergy and impact
• Commitment of the applicant institution to collaborative efforts
• Availability of funds
• Collaborative interaction with NIOSH researchers and subject matter experts
Review of Risk Posed by Applicants

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

Any application awarded in response to this FOA will be subject to the UEI, SAM Registration and Transparency Act requirements. If the application is under consideration for funding, NIOSH will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

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 recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be allowable as an expanded authority, but only if authorized by CDC.

Diversity Supplements: NIOSH support efforts that 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 FOA PA-21-071 for information or contact the NIOSH Scientific Program Official (SPO) assigned to this FOA.

2. Administrative and National Policy Requirements

All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement and CDC Administrative Requirements (policies) found on the CDC Office of Financial Resources, Grant, webpage, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please visit here and here for more information.

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see here and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see link.
• HHS-funded health and education programs must be administered in an environment free of sexual harassment, see link. For information about CDC's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what CDC's expectations are for institutions and the individuals supported on CDC-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm .
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see here and here.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at link or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), HHS/CDC awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all CDC grants and cooperative agreements except fellowships.

Additional Requirements (ARs)

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

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

Generally applicable ARs:

AR-1: Human Subjects Requirements

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

AR-3: Animal Subjects Requirements

AR-9: Paperwork Reduction Act Requirements

AR-10: Smoke-Free Workplace Requirements

AR-11: Healthy People 2020

AR-12: Lobbying Restrictions

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

AR-14: Accounting System Requirements

AR-16: Security Clearance Requirement

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

AR-22: Research Integrity

AR-24: Health Insurance Portability and Accountability Act Requirements

AR-25: Data Management and Access

AR-26: National Historic Preservation Act of 1966

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

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

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

AR-31: Research Definition

AR-32: Appropriations Act, General Provisions

AR-33: United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern

AR-34: Accessibility Provisions and Non-Discrimination Requirements

AR-36: Certificates of Confidentiality

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

Organization specific ARs:

AR-8: Public Health System Reporting Requirements

AR-15: Proof of Non-profit Status

AR-23: Compliance with 45 CFR Part 87

Additional Policy Requirements

The following are additional policy requirements relevant to this FOA.

HHS Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences and Meetings, Food, Promotional Items and Printing Publications

This policy supports the Executive Order on Promoting Efficient Spending (EO 13589), the Executive Order on Delivering an 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 HHS Policy on Promoting Efficient Spending.

Federal Funding Accountability and Transparency Act of 2006

Federal Funding Accountability and Transparency Act of 2006 (FFATA), Pub.L.No. 109 282, as amended by section 6202 of Pub.L.No. 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, http://www.usaspending.gov/. For the full text of the requirements, please review the following website: https://www.fsrs.gov/.

Plain Writing Act

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

Tobacco and Nutrition Policies

The CDC supports implementing evidence-based programs and policies to reduce tobacco use and secondhand smoke exposure, and to promote healthy nutrition. CDC encourages all recipients to implement the following optional evidence-based tobacco and nutrition policies within their organizations. These policies build on the current federal commitment to reduce exposure to secondhand smoke, which includes The Pro-Children Act, 20 U.S.C. 7181-7184 that prohibits smoking in certain facilities that receive federal funds.

Tobacco:

Tobacco-free indoors no use of any tobacco products (including smokeless tobacco) or electronic cigarettes in any indoor facilities under the control of the applicant.

Tobacco-free indoors and in adjacent outdoor areas no use of any tobacco products or electronic cigarettes in any indoor facilities, within 50 feet of doorways and air intake ducts, and in courtyards under the control of the applicant.

Tobacco-free campus no use of any tobacco products or electronic cigarettes in any indoor facilities and anywhere on grounds or in outdoor space under the control of the applicant.

Nutrition:

Healthy food service guidelines that at a minimum align with Health and Human Services and General Services Administration Health and Sustainability Guidelines for Federal Concessions and Vending Operations for cafeterias, snack bars, and vending machines in any facility under the control of the recipient organization and in accordance with contractual obligations for these services. The following are resources for healthy eating and tobacco free workplaces:

https://www.cdc.gov/nccdphp/dnpao/

https://www.cdc.gov/obesity/strategies/food-serv-guide.html

Applicants should state whether they choose to participate in implementing these two optional policies. However, no applicants will be evaluated or scored on whether they choose to participate in implementing these optional policies.

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

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

If a project is determined to be DURC, a risk/benefit analysis must be completed. CDC will work collaboratively with the award recipient to develop a risk mitigation plan that the CDC must approve. The USG policy can be found at https://www.phe.gov/s3/dualuse/Pages/default.aspx.

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.

Federal Information Security Management Act

All information systems, electronic or hard copy which contain Federal data need to be protected from unauthorized access. This also applies to information associated with NIOSH grants and contracts. Congress and the OMB have instituted laws, policies and directives that govern the creation and implementation of federal information security practices that pertain specifically to grants and contracts. The current regulations are pursuant to the Federal Information Security Management Act (FISMA), 44 U.S.C. 3541 et seq. The applicability of FISMA to NIOSH recipient applies only when recipients collect, store, process, transmit or use information on behalf of HHS or any of its component organizations. In all other cases, FISMA is not applicable to recipients of grants, including cooperative agreements. The recipient retains the original data and intellectual property, and is responsible for the security of this data, subject to all applicable laws protecting security, privacy, and research. When information collected by a recipient is provided to HHS, responsibility for the protection of the HHS copy of the information is transferred to HHS and it becomes the agency's responsibility to protect that information and any derivative copies as required by FISMA.

Data Management Plan(s)

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

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

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

Certificates of Confidentiality: Institutions and investigators are responsible for determining whether research they conduct is subject to Section 301(d) of the Public Health Service (PHS) Act. Section 301(d), as amended by Section 2012 of the 21st Century Cures Act, Pub.L.No. 114-255 (42 U.S.C. 241(d)), states that the Secretary shall issue Certificates of Confidentiality (Certificates) to persons engaged in biomedical, behavioral, clinical, or other research activities in which identifiable, sensitive information is collected. In furtherance of this provision, CDC-supported research commenced or ongoing after December 13, 2016, in which identifiable, sensitive information is collected, as defined by Section 301(d), is deemed issued a Certificate and therefore required to protect the privacy of individuals who are subjects of such research. Certificates issued in this manner will not be issued as a separate document, but are issued by application of this term and condition to this award. See Additional Requirement 36 to ensure compliance with this term and condition.

Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial CDC programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipient's activities by involvement in and otherwise working jointly with the award recipient 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 recipient for the project, although specific tasks and activities may be shared among the recipient and HHS/CDC as defined below.

Principal Investigator (PI)

The PDs/PIs (recipients) will have primary responsibility for the following elements:

• Establish research activities focused on aspects of automation, robotics, and intelligent mining systems to improve workplace safety and health in U.S. mining operations;
• Coordinate all technical, scientific, and administrative aspects of activities at the awarded institution and at other sites that may be supported by subcontracts to this award;
• Ensure that data and results are published in a timely manner and shared publicly with the research community;
• Propose evaluation measures for activities conducted in support of all parts of this program, including process evaluation and outcome measures where feasible;
• Interface with NIOSH programmatic staff (researchers and subject matter experts) to insure the required cooperative and collaborative efforts during the term of the cooperative agreement award;
• Retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and CDC policies;
• Participate in regularly scheduled and/or ad hoc conference calls with NIOSH to review progress to date, review planned activities, and exchange ideas for future activities;
• Prepare written yearly progress reports and participate in regularly scheduled and/or ad hoc conference calls with NIOSH to review progress to date, review planned activities, and exchange ideas for future activities;
• Meet with NIOSH Scientific Program Official, NIOSH Project Scientist and other staff of the NIOSH Mining Program to review progress, share information, and coordinate research activities. The meeting will be a coordinated effort and should be held on an annual or bi-annual basis depending on the needs. For budget preparation, assume a full 1-day or 2-day meeting and lodging in either Atlanta, GA, Pittsburgh, PA or where the grant recipients are located;
• Facilitate collaboration with investigators, partners, and institutions to share existing expertise and engage in joint interventions to advance the scientific evidence related to automation, robotics, and intelligent mining systems to eliminate mining fatalities;
• Send to NIOSH, in approved electronic format, the final copies of all materials developed with support from NIOSH and made available to the public, subject to any specific legal caveats on use or copyright protection. Progress and final reports are to be Federal Law 508-compliant for public use;
• Assign an individual the responsibility for information technology transfer and dissemination, to ensure effective communication and transfer of important research and administrative information to the NIOSH Project Scientist. Such information may include research-related data, computation and submittal of research data, coordination of special meetings or conferences, submittal of research materials, and other research activities conducted by the program;
• Analyzing data and disseminating findings in peer-reviewed journals and presentations at scientific conferences and other meetings;
• Complying with the responsibilities for the Extramural Investigators as described in the Policy on Public Health Research and Non-research Data Management and Access; and
• Consulting with CDC/NIOSH to ensure compliance with relevant grant policies and regulations.

NIOSH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

NIOSH Scientific Program Official

The assigned HHS/CDC/NIOSH Scientific Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Award.

The NIOSH Scientific Program Official will have the primary responsibility for the following:

• Grant management, programmatic, scientific, and stewardship responsibilities will be provided by the assigned NIOSH Scientific Program Official named in the notice of grant award. These responsibilities are inherently governmental and are separate from any substantial involvement with scientific and technical matters. This helps ensure that the sponsoring agency is appropriately managing the research and related activities of the recipient institution funded under a cooperative agreement as a federal assistance funding mechanism;
• Monitor and evaluate the activities, performance, and accomplishments of the recipient through conference calls, site visits, and review of project reports;
• Receive, review, and comment on draft materials and plans consistent with the section description immediately below, such as research materials, evaluation plan, and tools;
• Carry out administrative, scientific, and technical-related duties such as grant cycle or funding information; programmatic approvals and recommendations; and consultation or technical assistance pertaining to administration requirement of award. Monitor and process Just-In-Time (JIT) information for research projects; approve final reports before release and distribution; communicate guidance and policy; facilitate budget recommendations; and disseminate recipient information such as the Annual Report and research reports;
• Provide guidance or information for addressing recipient inquiries; and
• Jointly convene a 1-day or 2-day workshop meeting annually with recipients in cooperation with the NIOSH Project Scientist to review and share recipient information and products, discuss technical and coordination plans or issues, build partnership among the funded institutions, and coordinate partnership and/or research activities.

NIOSH Project Scientist (Mining)

A NIOSH Intramural Scientist will serve as a Project Scientist to provide substantial scientific involvement and subject matter expertise for health and safety protection with policies, programs, and practices that promote safety and health, prevent disease, and advance research focused on aspects of robotic and intelligent mining technology and workplace safety research. Specific responsibilities, in coordination with the NIOSH Scientific Program Official, may include the following:

• Assist the NIOSH's Office of Extramural Programs (OEP) and NIOSH Mining intramural researchers in reporting or disseminating nonconfidential research results and relevant safety and health information to appropriate Federal, State, and local agencies, the scientific community, and other interested parties;
• Upon request of the award recipient, provide expert consultation in the area of occupational health and safety protection with policies, programs, and practices that promote safety and health, prevent disease, and provide other occupational safety and health related functions and activities as needed;
• Identify opportunities for collaboration with NIOSH intramural research and researchers, serving as the point of contact and facilitating interaction between the NIOSH researchers and the grantee;
• Serve as a subject matter expert for NIOSH;
• Collaborate on scientific projects, upon request;
• Provide technical assistance to recipients in support of their leadership and responsibility for aspects of robotic and intelligent mining technology and workplace safety research;
• With the Scientific Program Official, facilitate coordination and collaboration among recipients on meeting agendas, prevention activities, and opportunities as needed;
• Attend and actively participate in the planning and implementation of recipient meetings as needed;
• Facilitate collaborative efforts with NIOSH and others to compile and disseminate program results through presentations, publications, and other relevant channels;
• Review research materials developed by the recipients for consistency, appropriateness, and technical accuracy;
• Provide technical assistance to recipients for evaluating the impact of the research on improving work practices, reducing work-related injury and illness, and increasing the understanding of safety and health practices in mining environments;
• Assist NIOSH Scientific Program Official with convening a 1-day or 2-day meeting annually with recipients, to review and share recipient information and products, discuss technical and coordination plans or issues, build partnership among the funded institutions and between the funded institutions and NIOSH, and coordinate partnership and/or research activities; and
• In accordance with HHS/CDC/NIOSH policies and guidelines, the NIOSH Project Scientist may publish with the recipient, if mutually agreeable and warranted by the nature and extent of their intellectual contribution to the program or project.

Areas of Joint Responsibility

Joint responsibilities may include:

Participating in a conference, meeting, or calls to be held in conjunction with NIOSH and Partners to disseminate research findings and outcomes to the public safety and health community and stakeholders.

Collaborative work to address occupational safety and health issues at a national level.

Working groups may be created for specific purposes.

Business and Other Non-Programmatic Management

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


Coordination, Communication, and Cooperation

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

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) in eRA Commons at least annually and financial statements as required in the HHS Grants Policy Statement. Program staff will evaluate the effectiveness of resource sharing as part of the administrative review of each Non-Competing Continuation Grant Progress Report.

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

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

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

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

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

2) similar information on all sub-awards/ subcontracts/ consortiums over $25,000. All recipients of applicable CDC grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) on all subawards over $25,000. See the HHS Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.

The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Submission of Reports

The Recipient Organization must submit:

1. Yearly Non-Competing Grant Progress Report. The RPPR is due 90 to 120 days before the end of the current budget period. The form (instructions) 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) 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. Annual report suitable for public distribution submitted to the NIOSH/OEP Scientific program official at the end of the federal fiscal year (September 30). This report should include narrative descriptions of high-impact outcomes of individual programs that are noteworthy. Specific guidance on report content will be provided by NIOSH.

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

Content of Reports

1. Yearly Non-Competing Grant Progress Report

The recipient’s continuation application/progress report should include:

Description of Progress during Annual Budget Period: Current Budget Period Progress reported on the RPPR form in eRA Commons. 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

Research Aim/Project: purpose, status (met, ongoing, and unmet), challenges, successes, and lessons learned.

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 safety and health policy. This section should be understandable to a variety of audiences, including policy makers, practitioners, public safety and health programs, healthcare institutions, safety institutions, professional organizations, community groups, researchers, and other potential users. The PI should identify the research findings that were translated into public safety and health policy or practice and how the findings have been or may be adopted in public safety and 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 scientific findings be translated into public safety and health practices or inform public safety and health policy?
• How will the project improve or effect the translation of research findings into public safety and health practice or inform policy?
• How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in public safety and 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 safety and 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 safety and health. Questions to consider in preparing this section include:

• How will this project lead to improvements in public safety and/or health?
• How will the findings, results, or recommendations been used to influence practices, procedures, methodologies, etc.?
• How will the findings, results, or recommendations contribute to documented or projected reductions in morbidity, mortality, injury, disability, or disease?

Current Budget Period Financial Progress: Status of obligation of current budget period funds and an estimate of unobligated funds projected provided on an estimated FFR.

New Budget Period Proposal: Detailed operational plan for continuing activities in the upcoming budget period, including updated Measures of Effectiveness for evaluating progress during the upcoming budget period. Report listed by Research Aim/Project.

Project Timeline: Include planned milestones for the upcoming year (be specific and provide deadlines).

New Budget Period Budget: Detailed line-item budget and budget justification for the new budget period. Use the CDC budget guideline format.

Publications/Presentations: Include publications/presentations resulting from this CDC grant only during this budget period. If no publication or presentations have been made at this stage in the project, simply indicate Not applicable: No publications or presentations have been made."

IRB Approval Certification: Include all current IRB approvals to avoid a funding restriction on your award. If the research does not involve human subjects, then please state so. Please provide a copy of the most recent local IRB and CDC IRB, if applicable. If any approval is still pending at time of APR due date, indicate the status in your narrative.

Update of Data Management Plan: The DMP is considered a living document that will require updates throughout the lifecycle of the project. Investigators should include any updates to the project’s data collection such as changes to initial data collection plan, challenges with data collection, and recent data collected. Applicants should update their DMP to reflect progress or issues with planned data collection and submit as required for each reporting period.

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: eRA Common Registration & Accounts. Organizations not yet registered can go to Welcome to the 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 here.

3. Annual Report
This report should include narrative descriptions of high-impact outcomes of individual programs that are noteworthy. Specific guidance on report content will be provided by NIOSH.

4. Final Report

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 safety and health impacts based on the investment. The final report should include:

• Research Aim/Project Overview: The PI should describe the purpose and approach to the project, including the outcomes, methodology and related analyses. Include a discussion of the challenges, successes and lessons learned. Describe the collaborations/partnerships and the role of each external partner.
• Translation of Research Findings: The PI should describe how the findings will be translated and how they will be used to inform policy or promote, enhance or advance the impact on public safety and health practices. This section should be understandable to a variety of audiences, including policy makers, practitioners, public safety and health programs, healthcare institutions, safety 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 safety and 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 safety and 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.

Specific guidance for the final report and annual outcome update is available on the NIOSH OEP website under Grant Closeout.

4. 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.

Section VII. Agency Contacts

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



Application Submission Contacts

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

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov
Hours: Monday - Friday, 7am - 8pm U.S. Eastern Time
Finding Help Online: https://grants.nih.gov/support/index.html (preferred method of contact)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Hours: 24 hours a day, 7 days a week; closed on Federal holidays



Scientific/Research Contact(s)

Maria Lioce, MD
Office of Extramural Programs
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention (CDC)
Telephone: 404-498-2575
Email: MLioce@cdc.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Tonya Knox, MPH, CHES, ICPS
Office of Grants Services (OGS)
Office of Financial Resources (OFR)
Centers for Disease Control and Prevention (CDC)
Telephone: 678-475-4937
Email: srq0@cdc.gov

Section VIII. Other Information

Other CDC funding opportunity announcements can be found at www.grants.gov. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement .

Authority and Regulations

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