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

Centers for Disease Control and Prevention (CDC)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this Funding Opportunity Announcement (FOA) might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.

Components of Participating Organizations

National Institute for Occupational Safety and Health (NIOSH

Funding Opportunity Title

Underground Mine Evacuation Technologies and Human Factors Research

(U60)

Activity Code

U60 Research Cooperative Agreement

Announcement Type

New

Related Notices

None

Funding Opportunity (FOA) Number

PAR-21-165

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed.
See Section III. 3. Additional Information on Eligibility.

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

93.262

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit meritorious applications from universities with graduate programs in mining and explosives engineering to develop and conduct research specifically focused on aspects of underground mine evacuation technologies and human factors related to mine emergencies, to build on NIOSH's work to address mandates in the Mine Improvement and New Emergency Response Act of 2006 (P.L. 109-236) and P.L. 116-94.

Key Dates
Posted Date

February 10, 2021

Open Date (Earliest Submission Date)

April 1, 2021; February 1, 2022

Letter of Intent Due Date(s)

March 12, 2021; January 10, 2022

Application Due Date(s)

April 12, 2021; February 10, 2022

No late applications will be accepted for this FOA.

Electronically submitted applications must be submitted no later than 5:00 p.m., U.S. Eastern Time (ET).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

May 2021; May 2022

Advisory Council Review

June 2021; June 2022

Earliest Start Date

 September 1, 2021; September 1, 2022

Expiration Date

October 1, 2022

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

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

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

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

    Background

    Despite advances in technology and the work environment, mining remains one of the most challenging and dangerous occupations in the United States. The number of fatality rate in mining is five times higher than the national average for other industries according to the U.S. Bureau of Labor Statistics (BLS).

    There were 331,610 workers in the Mining Sector in 2019, according to data collected by the Mining Safety and Health Administration (MSHA) from mine operators and independent contractors. In 2019, MSHA reported 12,968 mining operations in the United States. MSHA data for the same period shows 27 fatalities, with the industry average from 2009-2018 being 36 annual fatalities. The MSHA data shows that 3,926 nonfatal lost-time injuries occurred in 2019, an overall rate of 1.53 per 100 full-time equivalent (FTE) workers. According to data from the NIOSH Mining Program, BLS, and MSHA, the rate of nonfatal lost-time underground injuries in 2019 was greater than the rate for surface injuries (2.70 vs. 1.27 per 100 FTE workers).

    In 2006, the Mine Improvement and New Emergency Response Act of 2006, also known as the MINER Act, was signed because of the many challenges in the mining industry. This legislation contains a number of provisions to improve safety and health in America's mines.

    Under the MINER Act of 2006, the Office of Mine Safety and Health Research (OMSHR) was established  within the NIOSH. One purpose of this office is to enhance the development of new technology and technological applications and to ensure adequate capacity in engineering and science disciplines important to mine safety and health.

    The MINER Act grants the OMSHR the authority to award competitive grants to:

    • improve mine safety and health in general;
    • encourage the development and manufacture of mine safety equipment;
    • award education institutions or private laboratories for the performance of product testing or related work with respect to new mine technology and equipment.

    Purpose

    The purpose of this FOA is to provide grant opportunities to universities with graduate programs in both mining and explosives engineering to 1) support research related to mine emergencies, and 2)  build on the work of the National Institute for Occupational Safety and Health (NIOSH) to address mandates in the Mine Improvement and New Emergency Response Act of 2006 (P.L. 109-236) and P.L. 116-94 to advance the safety and health of mine workers in our nation.

    Research priorities include developing new wireless communication devices and methodologies; developing training, systems, and tools to facilitate miner self-escape; and continuing to improve the design of refuge alternatives.

    Other possible research areas of interest may include other health and safety issues in related areas, particularly those related to mine emergencies caused by mine fires and explosions. Interested applicants are encouraged to consider aspects of their graduate program in mining and explosives engineering, including unique facilities, that could best support research related to mine emergencies and other aspects of the MINER Act.

    A key factor of this announcement is the Congressional restriction placed on the funding which limits applications to U.S.-based programs that have an Accreditation Board for Engineering and Technology, Inc. (ABET) accredited degree program in mining or mineral engineering and offer graduate programs in both mining and explosives engineering.

    Healthy People 2030 and the National Strategic Priorities

    Healthy People 2030 is the fifth edition of Healthy People. It aims at new challenges and builds on lessons learned from its first 4 decades. HHS has approved the Healthy People 2030 framework which is based on recommendations made by the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030

    The United States Public Health Service (PHS) is committed to achieving nationwide improvements in health for a society in which all people live long, healthy lives. The vision, mission, and goals are found in Healthy People 2030.

    Public Health Impact

    Underground mine evacuation technologies and human factors research will support the mission of NIOSH in protecting and promoting the 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.
    Underground mine evacuation technological and human factors research developments could be utilized to enhance mine safety and accident response.

    NORA Sectors and Health and Safety Cross-sectors

    In the Project Description/Abstract, state which industry sector(s) and health and safety cross-sector(s) the proposed work will address. Provide a clear rationale for how the intended outcomes of the proposed project will contribute to the specified strategic and intermediate goals. Provide a statement about which NORA sector(s) and cross-sector(s) and which NIOSH intermediate goals of the NIOSH Program Portfolio  are being addressed (if applicable).

    2. Approach

    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 the NIOSH Mining Program 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

    The Underground Mine Evacuation Technologies and Human Factors Research cooperative agreement will support applicants that can perform work within the scope and that have an ABET-accredited degree program in mining or mineral engineering and offer graduate programs in both mining and explosives engineering.

    Research Objectives

    The objective of this cooperative agreement is to address research related to mine emergencies, including but not limited to:

    • new wireless communication devices and methodologies,
    • training, systems and tools to facilitate miner self-escape and,
    • improvements in the design of refuge alternatives. 

    NIOSH also encourages research proposals that address other health and safety issues in related areas, particularly those related to mine emergencies caused by mine fires and explosions, consistent with the intent of the MINER Act.

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

    Proposed goals and objectives should be clearly stated in the application and directly linked to the occupational health and safety issues that will be addressed. Applicants are expected to justify their proposal by describing the research gap or emerging issue that is addressed, and the potential impact the proposed work may have.

    Applicants should provide data to support their selection of proposed work, such as morbidity or mortality rates, indicators of the size of the population at risk including estimates of the target population's potential risk of exposure to the hazard, frequency of exposure, or sociodemographic factors such as age, gender, and race/ethnicity.

    Similarly, applicants may provide qualitative data and/or information that describe exposures, the magnitude of the problem, and potential benefits and impacts of addressing the issue. Qualitative data and/or information may be necessary when the nature of the exposure or population at risk make collecting large-scale, representative quantitative data difficult.

    Outputs and Outcomes

    Underground mine evacuation technologies and human factors research will support the NIOSH goal to reduce fatalities related to mine emergencies caused by mine fires and explosions in the United States.

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

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

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

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

    Note to Applicants

    In the Project Description/Abstract and Research Strategy (Significance) sections of your application, provide a brief statement about expected outputs and outcomes of your proposed research.

    Intermediate Goals

    NIOSH has also identified intermediate goals. These are specific actions needed to achieve or help achieve the strategic goals. In addition, NIOSH has identified certain areas where extramural research is specifically encouraged to fill a gap or provide a capacity that NIOSH cannot. Descriptions and updates of the strategic and intermediate goals are on the NIOSH website.

    Provide a rationale for how the proposed research will contribute to NIOSH’s strategic goals and priority research areas to include the recently published NIOSH Strategic Plan. For example, project should indicate if and how they address any of the priority Mining-related goals that are found in the NIOSH Strategic Plan: FY’s 2019-2023 (specifically those provided in the Research goals).

    Note to Applicants

    Provide in the Project Description/Abstract the Intermediate Goals https://www.cdc.gov/niosh/about/strategicplan/researchgoals.html

    Applicants are strongly encouraged to review the language from the NORA Mining Agenda and the 2019-2023 Mining Program Strategic Plan.

    Target Population

    The beneficiaries of these cooperative agreements are miners working in the United States. However, to achieve this, the research might target United States vulnerable mine worker populations to address the additional increased safety and health risks associated with occupational health disparities, changing worker demographics, and changing nature of work.

    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.

    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 with local and state organizations, universities, manufacturers, government agencies, professional organizations, engineering and safety training partner organizations, community organizations, health care institutions, business groups, and labor organizations to carry out research activities, conduct outreach programs, promote awareness, and disseminate information.

    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 that strengthen the proposed research in terms of 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 health actions by involving procedures that are useful, feasible, ethical, and accurate. Understanding and applying the elements of this framework for research projects may enhance planning effective public health strategies, improving existing programs including evidence-based activities, and demonstrating beneficial results and impact of federal funding.

    Translation Plan

    Translation, communication, and dissemination projects are encouraged as a means of interpreting and delivering the research findings to those in a position to adopt and implement improvements, as well as overcome barriers to improving the health of people who work. The translation of evidence-based approaches into workplace practice through educational, outreach, and other adoption-focused efforts is of utmost importance for the Mining program. Although research strengthens our understanding of the determinants of injury, illness, and death, the potential for impact of research findings is found when paired with pragmatic approaches to move findings into practice.

    Applicants are expected to present and publish results on a periodic basis to promote dissemination of knowledge gained from the work. NIOSH is required to provide evidence of such dissemination and extending the knowledge gained to the mining industry. Education of graduate students through degree completion focused on the topic of this cooperative agreement is considered an additional benefit.

    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 - work collaboratively to:

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

    Note to Applicants

    Applicants must provide a brief statement about how their proposed research addresses r2p in both the Description (Abstract) and in the Research Strategy (Significance). Describe the anticipated strategies for translation and/or dissemination of research findings, including 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, CDC/NIOSH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New - An application that is submitted for funding for the first time.

    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 FOA.

    Clinical Trial?

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

    Need help determining whether you are doing a clinical trial?  

    Funds Available and Anticipated Number of Awards

    Estimated Total Funding: NIOSH intends to commit approximately up to $4 million in total costs (direct and indirect) over the entire project period (up to 4 years). 

    Up to $1 million total cost (direct and indirect costs) in FY 2021.
    Future year amounts will depend on annual appropriations.

    Anticipated number of awards: 1

    NIOSH anticipates funding one award through this announcement.

    The award issued under this FOA is contingent upon the availability of funds and the submission of enough meritorious applications.

    Award Budget

    Up to $1,000,000 Total Costs (direct and indirect costs) per budget period.

    Award Ceiling: $1,000,000 total costs per budget period

    Award Floor: $725,000 total costs per budget period

    NIOSH intends to commit up to approximately $1 million 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.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Other

    • U.S. academic institution that offers (1) an ABET-accredited undergraduate degree in mining or minerals engineering and (2) graduate programs in both mining and explosives engineering.

    Note to Applicants

    Documentation of an (ABET) accredited degree program in mining or mineral engineering and graduate programs in both mining and explosives engineering must be submitted by potential applicants to establish eligibility.

    Foreign Institutions

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

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The HHS Grants Policy Statement states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) – 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 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 the SAM internet site at https://www.sam.gov/index.html.
      Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.    
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration. 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 3-5 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.

    Eligible Individuals (Program Director/Principal Investigator)

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

    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.

    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 (1) an ABET-accredited undergraduate degree in mining or minerals engineering and (2) graduate programs in both mining and explosives engineering.  Enough detail must be provided in the proposal to clearly demonstrate the department meets all of these criteria.

    Responsiveness

    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.

    If an applicant exceeds the four-year period of performance limit or the total cost limit of $1,000,000 budget period (including consortium F&A costs), CDC/NIOSH will consider the application non-responsive, and it will not enter the peer review process. CDC/NIOSH 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 an ABET-accredited degree program in mining or mineral engineering and offer graduate programs in both mining and explosives engineering.

    Documentation of an (ABET) accredited degree program in mining or mineral engineering and graduate 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 (1) an ABET-accredited undergraduate degree in mining or minerals engineering and (2) graduate programs in both mining and explosives engineering.  Enough detail must be provided in the proposal to clearly demonstrate the department meets all of these criteria.

    Upon receipt, applications will be evaluated for completeness by NIH/CSR and CDC/NIOSH.  CDC/NIOSH will review all applications for responsiveness. Incomplete and/or non-responsive applications will not be reviewed.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    Only one application per institution (normally identified by having a unique DUNS number) is allowed.

    The FOA governs new applications.

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

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

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

    Applications that are incomplete or non-responsive to the eligibility criteria listed in this section will not be reviewed.

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

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Letter of Intent

    Due Date for Letter of Intent: 3/12/2021

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

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

    • 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.

    For this specific FOA, the Research Strategy is limited to 12 pages.

    Pages that exceed page limits described in this FOA will be removed and not forwarded for peer review, potentially affecting an application's score.

    Supporting materials for the Research/Training Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 100 pages for all appendices.

    Instructions for Application Submission

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

    List all performance sites that apply to the specific project.  

    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 (Expanded)

    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.

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modifications:

    All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

    Appendix

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

    PHS Human Subjects and Clinical Trials Information

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

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

    Format for Attachments

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

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

    Foreign Institutions

    For this FOA, applications from foreign institutions are not allowed  

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

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

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

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

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

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

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

    7. Other Submission Requirements and Information

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

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

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

    Important reminders:

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

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    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, 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 , 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 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 DUNS.

    When uploading supporting documentation for the Risk Questionnaire into this application package, clearly label the documents for easy identification of the type of documentation. For example, a copy of Procurement policy submitted in response to the questionnaire may be labeled using the following format: Risk Questionnaire Supporting Documents _ Procurement Policy.

    Duplication of Efforts

    Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year. Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source. Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted. Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.
    Report Submission: The applicant must upload the report under “Other Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.

    Important reminders: If the applicant has an FWA number, enter the 8-digit number. Do not enter the letters “FWA” before the number. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of the SF 424 (R&R) Application Guide and in the HHS Grants Policy Statement.

    See more resources to avoid common errors and submitting, tracking, and viewing applications:

    http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm

    http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm

    https://era.nih.gov/files/ASSIST_user_guide.pdf

    http://era.nih.gov/erahelp/ASSIST/

    Upon receipt, applications will be evaluated for completeness by the CDC Office of Grants Services (OGS) and responsiveness by OGS and CDC/NIOSH. Applications that are incomplete and/or nonresponsive will not be reviewed.

    Section V. Application Review Information
    1. Criteria

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

    Overall Impact

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

    Scored Review Criteria

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

     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 clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the applicant describe the following?

    • Outcomes and impacts to be achieved.
    • The institution’s capacity in mining safety and health.
    • 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 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 PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the collaboration of the project team with the mining industry and NIOSH adequate for achieving the proposed work?

    Innovation

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

    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?

    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?

    Additional Review Criteria

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

    Protections for Human Subjects

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

    For research that involves human subjects and meets the criteria for one or more of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the 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 policy on the Inclusion of Women and Racial and Ethnic Minorities in Research and the policy on the Inclusion of Persons Under 21 in 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/Pages/companion-guide.aspx.

    Additional Review Considerations

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

    Research to Practice (r2p)

    Reviewers will assess if the applicant has demonstrated about how their proposal addresses the research to practice (r2p) approach.

    Applications from Foreign Organizations

    Not applicable. Applications from foreign institutions are not allowed.

    Select Agent Research

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

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    Data Management Plan (DMP:

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

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

    The DMP 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 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 de-identified data).

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

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

    CDC Additional Requirement (AR)-25 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

    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.

    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 guidance for completing a detailed justified budget on the CDC website, at the following Internet address:
    http://www.cdc.gov/grants/interestedinapplying/applicationresources.html.

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

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

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review

    Group(s) convened by CDC/NIOSH, in accordance with NIOSH peer review and policy procedure 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.

    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) and collaboration 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

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

    3. Anticipated Announcement and Award Dates

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

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

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

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

    Expanded authorities: Expanded authorities: CDC has automatically waived the prior approvals listed in 45 CFR 75.308(d) (1) through (3) for any award resulting from an application under this FOA. In accordance with HHS regulation and CDC guidance, the awardee will have for the following three Expanded Authorities:

    • Carryover of unobligated balances from one budget period to a subsequent budget period.  Unobligated funds may be used for purposes within the scope of the project as originally approved. Recipients will report use, or intended use, of unobligated funds in Section 12 “Remarks” of the annual Federal Financial Report submitted in eRA Commons. If the GMO determines that some or all the unobligated funds are not necessary to complete the project, the GMO may restrict the recipient’s authority to automatically carry over unobligated balances in the future, use the balance to reduce or offset CDC funding for a subsequent budget period, or use a combination of these actions.
    • Extension of final budget period of a period of performance without additional funds up to 12 months with no change in the scope of work to ensure adequate completion of the originally approved project or program. The recipient must notify the awarding office, in writing, of the extension 10 days before the expiration date of the period of performance. Upon notification, the awarding office will revise the period of performance ending date and provide an acknowledgement to the recipient.
    • Pre-award costs up to (and including) 90 days before the beginning date of the initial budget period of a new or competing continuation award.

    The Expanded Authorities will be specified in the recipient award notices issued under this FOA.

    Diversity Supplements: NIOSH support efforts to enhance diversity of the research workforce through recruitment and support for students, post-doctorates, and eligible investigators from diverse backgrounds and groups under-represented in OSH research. To help accomplish this, supplemental funding will be considered after an application is awarded. Please refer to FOA PA-21-071 for information or contact the NIOSH Scientific Program Official (SPO) assigned to this FOA. Diversity supplements are contingent upon administrative review and availability of funds.

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants

     enrolled in CDC/NIOSH-funded studies, the awardee must provide CDC/NIOSH copies of documents related to all major changes in the status of ongoing protocols.

    PHS Human Subjects and Clinical Trials Information

    Note: The revised Common Rule defined clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Including behavioral health-related outcomes recognized that clinical trials may occur outside a biomedical context (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html).

    On June 18, 2018, HHS and 16 other federal departments and agencies issued a Final Rule to further delay the general compliance date for changes recently made to the revised Federal Policy for the Protection of Human Subjects (the Common Rule) for an additional 6 months until January 21, 2019 (https://www.hhs.gov/ohrp/final-rule-delaying-general-compliance-revised-common-rule.html).

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

    All instructions in the SF424 (R&R) Application Packages (Multi - Project Instructions for NIH and Other PHS Agencies) must be followed along with any additional instructions provided in this FOA.

    2. Administrative and National Policy Requirements

    All CDC/NIOSH cooperative agreement awards include the HHS Grants Policy Statement as part of the  Notice of Award.

    Overview of Terms and Conditions of Award and Requirements for Specific Types of Grants

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

    Specific additional requirements that apply to this FOA are the following:

    AR-1: Human Subjects Requirements

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

    AR-3: Animal Subjects Requirements

    AR-9: Paperwork Reduction Act Requirements

    AR-10: Smoke-Free Workplace Requirements

    AR-11: Healthy People 2020

    AR-12: Lobbying Restrictions

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

    AR-14: Accounting System Requirements

    AR-16: Security Clearance Requirement

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

    AR-22: Research Integrity

    AR-24: Health Insurance Portability and Accountability Act Requirements

    AR-25: Release and Sharing of Data

    AR-26: National Historic Preservation Act of 1966

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

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

    AR-30: Information Letter 10-006, Compliance with Section 508 of the Rehabilitation Act of 1973

    AR-31: Research Definition

    AR-32: FY 2012 Enacted General Provisions

    Organization Specific ARs:

    AR-8: Public Health System Reporting Requirements

    AR-15: Proof of Non-profit Status

    AR 23: Compliance with 45 C.F.R. Part 87

    To view brief descriptions of relevant CDC requirements visit: HHS/CDC Requirements.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination based on race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html./index.html.

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

    Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.   

    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), NIH 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 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Review of Risk Posed by Applicants

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

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

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

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

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

    Additional 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 and Efficient, Effective, and Accountable Government (EO 13576) and the Office of Management and Budget Memorandum on Eliminating Excess Conference Spending and Promoting Efficiency in Government (M-35-11). This policy applies to all new obligations and all funds appropriated by Congress. For more information, visit the HHS website.

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

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

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

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

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

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

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

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

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

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

    Data Management Plan(s)

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

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

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

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

    Cooperative Agreement Terms and Conditions of Award

    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 as a whole, 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 underground mine evacuation technologies and human factors research related to mine emergencies to reduce work-related health and safety risks, promote health and safety, and prevent disease and injury in the workplace;
    • 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 to insure the required collaborative effort 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 annually with NIOSH at for a review meeting at the Pittsburgh or Spokane Mining Research Division or other mutually agreeable site to review progress to date, review planned activities, and exchange ideas for future activities to facilitate collaboration with NIOSH researchers;
    • Facilitate collaboration with investigators, partners, and institutions to share existing expertise and engage in joint interventions to advance the scientific evidence related to underground mine evacuation technologies and human factors research related to mine emergencies;
    • 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; and
    • Assign an individual the responsibility for information technology transfer and dissemination, to ensure effective communication and transfer of important training and administrative information to NIOSH Project Scientist.
    • Complying with the responsibilities for the Extramural Investigators as described in the Policy on Public Health Research and Non-research Data Management and Access.
    • Consulting with CDC/NIOSH to ensure compliance with relevant grant policies and regulations.

    CDC/NIOSH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below: 

    NIOSH will have substantial involvement regarding scientific and technical expertise on research activities, strategic planning, prospective coordination, national sector goals and activities, and time-critical data needs or reporting. All such activities will be fully coordinated between the NIOSH Project Scientist, the NIOSH's Office of Extramural Programs (OEP) and the award recipient. NIOSH staff will participate in grantee meetings (in person or via regularly scheduled conference calls) to provide insight on NIOSH programs and priorities.

    CDC/NIOSH staff will assist the PI, as needed, in complying with the Investigator responsibilities described in the Policy on Public Health Research and Non-research Data Management and Access.

    • Grant management, programmatic, scientific, and stewardship responsibilities will be provided by Maria S Lioce, MD or other assigned NIOSH Scientific Program Official named in the notice of grant award. These responsibilities are inherently governmental and are separate from any substantial involvement with scientific and technical matters. This helps ensure that the sponsoring agency is appropriately managing the research and related activities of the recipient institution funded under a cooperative agreement as a federal assistance funding mechanism.
    • 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.
    • Federal agency personnel involved with all awards made under this announcement will work together cooperatively as a team to help ensure 1) proper stewardship of the funds awarded, 2) accurate and clear communications with the awardee(s), and 3) regular evaluation of awardee progress and performance toward completing the project on time and within budget.

    NIOSH Project Scientist

    A NIOSH Intramural Scientist will serve as a Project Scientist to provide substantial scientific involvement and subject matter expertise for health protection with policies, programs, and practices that promote safety and health, prevent disease, and advance research focused on aspects of underground mine evacuation technologies and human factors research related to mine emergencies. 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;
    • Provide expert consultation in the area of occupational health protection with policies, programs, and practices that promote safety and health, prevent disease, and provide other occupational health and safety – related functions and activities as needed;
    • Serve as a subject matter expert for NIOSH;
    • Collaborate on scientific projects, upon request;
    • Facilitate collaborative efforts among recipients on meeting agendas, prevention activities, and opportunities as needed;
    • Help ensure consistent use and delivery of existing miner safety and health training materials;
    • Facilitate collaborative efforts with NIOSH and others to compile and disseminate program results through presentations, publications, and other relevant channels; and
    • In accordance with HHS/CDC/NIOSH policies and guidelines, the NIOSH Project Scientist may publish with the awardee, 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 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.
    3. Reporting

    When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements.

    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) available at www.fsrs.gov on all subawards over

    $25,000. See the HHS Grants Policy Statement.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a  Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Submission of Reports

    The Recipient Organization must provide CDC/NIOSH the following reports:

    1. Yearly Non-Competing Grant Progress Report is due 90 to 120 days before the end of the current budget period. The RPPR (https://grants.nih.gov/grants/rppr/index.htm;

    https://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf) is to be completed on the eRA Commons website. The progress report will serve as the non-competing continuation application. Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

    2. Annual Federal Financial Report (FFR) SF 425 is required and must be submitted through eRA Commons within 90 days after the end of the calendar quarter in which the budget period ends. The FFR should only include those funds authorized and disbursed during the timeframe covered by the report. The final FFR must indicate the exact balance of unobligated funds and may not reflect any unliquidated obligations. There must be no discrepancies between the final FFR expenditure data and the Payment Management System's (PMS) cash transaction data.

    Failure to submit the required information in a timely manner may adversely affect the future funding of this project. If the information cannot be provided by the due date, you are required to submit a letter explaining the reason and date by which the Grants Officer will receive the information.

    Recipients must submit closeout reports in a timely manner. Unless the Grants Management Officer (GMO) of the awarding Institute or Center approves an extension, recipients must submit a final FFR, final progress report, and Final Invention Statement and Certification within 90 days of the end of grant period. Failure to submit timely and accurate final reports may affect future funding to the organization or awards under the direction of the same Project Director/Principal Investigator (PD/PI).

    FFR (SF 425) instructions for CDC recipients are now available

    at https://grants.nih.gov/grants/forms/report_on_grant/federal_financial_report_ffr.htm. For further information, contact GrantsInfo@nih.gov. Additional resources concerning the eFSR/FFR system, including a User Guide and an on-line demonstration, can be found on the eRA Commons Support Page: https://grants.nih.gov/support/index.html.

    3. Final Report should provide sufficient detail for CDC/NIOSH to determine if the stated outcomes for the funded research have been achieved and if the research findings resulted in public health impact based on the investment.
    The final progress report, the Final Invention Statement and Certification form, equipment/inventory report, and the Final financial and performance reports (FFR) are required no more than 90 days after the end of the project period. Specific guidance on report content will be provided by NIOSH.

    Section VII. Agency Contacts

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

    Application Submission Contacts

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

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

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

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    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)

    Ferrinnia (Toni) Augustus-High, MSA, CGMS
    Grants Management Specialist
    Office of Grants Services (OGS)
    Office of Financial Resources (OFR)
    Office of the Chief Operating Officer (OCOO)
    Centers for Disease Control and Prevention (CDC)
    Telephone: 770-488-2906
    Email: wef9@cdc.gov

    Section VIII. Other Information

    Other CDC funding opportunity announcements can be found at www.grants.gov. Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

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

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