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.

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

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ 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 and 45 CFR Part 75. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement .

Despite many technological and work environment advances, mining remains one of the most challenging and demanding occupations in the United States. The fatality rate in mining is six times higher than the national average for other industries. While there were fewer fatalities in 2015 (28) than in 2013 (44) and 2014 (45), the industry average over the last 6 years has been 43 annual fatalities (http://arlweb.msha.gov/stats/charts/chartshome.htm).

Additionally, the severity of injuries for mining exceeds all other industries, with the highest percentage of lost work days per incident. There were 5,199 nonfatal lost-time injuries reported to the Mining Safety and Health Administration (MSHA) in 2014. These injuries occurred at an overall rate of 1.8 per 100 FTE workers. This compares to 5,258 nonfatal lost-time injuries in 2013, occurring at a matching rate. The 2014 nonfatal lost-time underground injury rate was greater than the surface injury rate (3.0 vs. 1.5 per 100 FTE workers). Sprains or strains were the most frequently reported type of injury, followed by fractures and chips; cuts, lacerations, and punctures; and contusions and bruises (http://www.cdc.gov/niosh/mining/statistics/MiningFactSheets.html).

Respiratory diseases, hearing loss, cumulative musculoskeletal injuries, and traumatic injuries are critical health concerns within the mining industry. In the last decade, death certificates list coal workers' pneumoconiosis, commonly called black lung disease, as a cause in more than 10,000 deaths. In addition, more than 65 percent of miners experience occupational hearing loss by the time they retire (http://www.cdc.gov/niosh/mining/statistics/default.html) As a result of the many challenges in the mining industry, the focus areas for mining training must encompass a wide range of hazards and risks.

In 1969, the Coal Mine Safety and Health Act provided funding for state health and safety training through grants by MSHA. The mining community in the Eastern United States is served by the MSHA Training Academy in Beckley, West Virginia (http://www.msha.gov/Programs/MineAcademy/Academy.asp). MSHA, under the Department of Labor, provides training to federal mine inspectors and mining professionals from other governmental agencies, the mining industries, and labor. MSHA also provides Part 46 Training Assistance for new employees, refresher training, new task training, and training on Site-specific Hazards. States use MSHA grant funds to provide federally mandated training to miners working at coal, metal, and nonmetal mines, both on the surface and underground. MSHA's State Grants Program distributes federal grants to 49 States and the Navajo Nation. Grants are made to the state agency program responsible for miners' health and safety. Most grant funds are used to support health and safety training courses and programs designed to reduce mining accidents, injuries, and illnesses. (http://arlweb.msha.gov/PROGRAMS/EPD4.HTM).

Since 1999, when the authorities of the Bureau of Mines were transferred to NIOSH, the Institute has supported the safety and health training of miners in the Western United States. NIOSH support for miner training has been provided through various projects, contracts, and grants, as well as the Western Mining Training Centers. These have included the Colorado School of Mines (Mine Safety and Health Program), the Missouri University of Science and Technology (formerly the University of Missouri at Rolla), and the University of Arizona (Western Mining Safety and Health Training Resource Center. In 2014, the University of Texas at Arlington Health and Safety Training Center was funded and joined the ongoing efforts in miner safety and health training. For more information, please visit the website of each training program.

The purpose of this FOA is to enhance the quality and availability of health and safety training for miners in the Western United States. Availability includes the frequency, geographic considerations, channels or partners of dissemination, culturally and/or educational appropriate training material, and other characteristics of a successful training program. As a result, NIOSH invites applications for cooperative agreements to support the development and implementation of training and education programs that:

• addresses the training needs of miners in the Western United States,
• develops and delivers training to miners in the Western United States,
• provides qualified instructors and faculty to conduct the training,
• evaluates the effectiveness and impact of the training program on reducing injuries and illnesses to miners, and
• coordinates with existing training programs and partnerships with industry, miners, and agencies, such as those offered by MSHA.

NIOSH intends that the training provided by this program will be consistent with recommendations and guidelines of the Occupational Safety and Health Administration (OSHA) and MSHA and that the training provided will not duplicate existing MSHA or OSHA training programs or those developed by current NIOSH grantees.

NIOSH is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020" (https://www.healthypeople.gov). The objectives of Healthy People 2020 related to occupational safety and health (OSH) are primarily addressed through the National Occupational Research Agenda (NORA). NORA, established by NIOSH and its partners to stimulate research and improve workplace practices, provides a framework to guide OSH research. The goal of NIOSH research and training programs is to support relevant, high quality, effective projects that demonstrate impact in reducing occupational disease and injury. Detailed information about the NIOSH Program Portfolio can be found at http://www.cdc.gov/niosh/programs/.

This training program will support the mission of NIOSH in protecting and promoting the health of mining workers. The training will help improve work practices and safety programs, reduce work-related injury and illness, and advance the understanding of safety and health practices at Western mine worksites.

Safety and health training for miners provides relevant knowledge regarding hazards encountered in the mining environment and practical tools for reducing risks for injuries and illness. The training program will assist workers in becoming active participants in improving the health and safety conditions under which they work and in establishing collaborative employer employee relationships for creating safe workplaces. 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.

NIOSH conducts research to find ways to reduce workplace injuries and illnesses; supports training programs; and provides technical assistance to and partners with CDC institutes; federal, state, national, and international partners; industry, including mining companies, industry associations, enforcement agencies, labor unions, equipment manufacturers, and suppliers; and academic institutions. NIOSH provides guidance during emergency response incidents and on use of respirators and other personal protective equipment (PPE). NIOSH also assists with exposure assessment and monitoring, including development of environmental sampling methods and strategies and collection of samples; observes specific work activities for exposures and other physical hazards; and assesses and gives guidance on engineering (ventilation assessments) and administrative workplace controls. NIOSH designs and provides worker information sheets for specific hazards and provides guidance and assistance for establishing worker registries and rosters. Additional information can be found at the following websites: http://www.cdc.gov/niosh/mining/topics/EmergencyManagement.html .

This cooperative agreement is intended to improve availability and quality of mineworker training in the western United States, where MSHA’s programs may not be as accessible to western miners. Moreover, it provides an opportunity to address gaps in current training materials, particularly those related to western mining operations.

An immediate goal of safety and health training for miners is to provide them with relevant knowledge regarding hazards encountered in the mining environment, personal protective equipment for protection of health and safety in an emergency, along with practical tools for reducing risks for injuries and illness. The training program should assist workers in becoming active participants in determining and improving the health and safety conditions under which they work and in establishing collaborative employer employee relationships for creating safe workplaces.

The training and education needs specific to miners in the western United States must be defined in the application, along with supporting data from industry, unions, and miners. These data are to be used to justify the proposed training and education of miners. In addition to identifying training needs, the application must provide information regarding the location and frequency of the training, along with characteristics of the miner cohort, if known (target or vulnerable workforce). The application also must clearly identify professional and experiential credentials of those performing the training. Ideally, training will occur not only at centralized facilities but also at mining worksites. As evidenced by letters of support, the application should justify the choice of location in terms of impact (for example, the number of miners trained, changes in competencies/behavior relevant to health and safety improvements, and reductions in incidents), as well as accessibility, feasibility, and cost.

Primary prevention of illness and injury among miners depends to a great extent on proper use and maintenance of engineering controls. Training programs should include this topic as part of an integrated approach.

NIOSH cooperative agreement awards made under this announcement are not intended to duplicate training currently available to western miners. To maximize the impact of miner training and to avoid unnecessary overlap with training programs provided by MSHA and OSHA, existing programs should be identified, summarized in the research and training plan, and considered for use. Further, any NIOSH-funded training for miners should be consistent with the current recommendations and guidelines of both OSHA and MSHA.

In the Project Description/Abstract, applicants must state which NORA cross-sectors (health/disease, exposures and other risks) they are addressing and a rationale for why and how the project will address these (this information must be placed).

The NIOSH Program Portfolio has been organized into Sector Programs that represent industrial sectors and seven health and safety Cross-Sector Programs organized around health outcomes based on the National Occupational Research Agenda (NORA). NIOSH also has Core and Specialty Programs that represent core activities, mandates, special emphasis areas, and methodological approaches.

http://www.cdc.gov/niosh/programs/default.html.

The proposed miner safety and health training program should accomplish the following:

• Address the training needs of mining personnel.
• Increase the number of qualified mine safety and health trainers in the western United States.
• Develop/offer and implement train the trainer courses.
• Develop and deliver health and safety training to miners working in the western United States (NOTE: exclude training in emergency response and hazmat materials).
• Provide qualified instructors and faculty to achieve the goals of this project.
• Starting in Year 2, report annually the results of a quantitative and qualitative evaluation of the effectiveness and impact of the training program, with regard to changes in the following:
• safety and health relevant behavior
• operational practices that reduce miner risks and reduce incidents
• frequency and severity of injuries and illnesses
• productivity and effectiveness of training and other indicators of performance.
• Coordinate with existing MSHA, OSHA, and other training programs.

This cooperative agreement is intended to support training of miners working in the western United States. The training program may include a combination of trainee targets, including miners, and train-the-trainer programs. As appropriate, the training program may include vulnerable mine worker populations to address increased safety and health risks associated with occupational health disparities

Partnerships are integral to 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 and training priorities. Partners often add expertise or specialized experience to the research/training team, which contributes to the success of the overall project.

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

An evaluation plan that addresses the impact of training on the safety and health of miners must be included in the application. The plan should clearly describe how training quality, effectiveness, and impact (short-term and long-term) will be evaluated.

Evaluations provide information for management and improve program effectiveness. The CDC program evaluation framework and NIOSH training evaluation tips may be helpful. The evaluations must also contain data for the calculation of return on NIOSH investment.

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

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

An intermediate outcome is what a stakeholder does with the knowledge or products generated by the research project to contribute to end outcomes (reductions in workplace illnesses, injuries, fatalities, and/or hazardous exposures). Intermediate outcomes include public or private policy changes, conduct of training or workshops based on project outputs, self-reported use or repackaging of research data, adoption of technologies or methods developed by NIOSH, implemented guidelines, and changes in workplace behaviors by either employers or employees.

Translation Plan

A translation plan is required to describe how applicants will measure progress toward achieving the aims and goals of the proposed training program. A logic model that describes the inputs, activities, outputs, intermediate outcomes, and expected long-term outcomes may be included.

Higher Education Institutions

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

The following types of Higher Education Institutions are always encouraged to apply for NIOSH support as Public or Private Institutions of Higher Education:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://dap.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=5e3079b8-44f2-43df-a0e7-9f379e8c48ed

Resubmissions. Applicants may not submit more than one application.

If your application is incomplete or nonresponsive to the eligibility criteria listed in this section, it will not enter into the review process. Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive federal funds constituting an award, grant, or loan

Responsiveness

If an applicant requests a funding amount greater than the ceiling of the award, CDC/NIOSH will consider the application nonresponsive, and it will not enter into the peer review process. CDC/NIOSH will notify the applicant that the application did not meet the submission requirements.

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 nonresponsive applications will not be reviewed.

Applicants must provide a statement about which NORA cross-sectors are being addressed and a rationale for how the proposed training will contribute to the specified priority area. They also must provide an explanation of how the proposed training program will contribute to the NIOSH Research to Practice (r2p) initiative and a statement about their expected Outcomes and Outputs (see Approach). This information must be placed in both the Description/Abstract and in the Research/Training Strategy (Significance) sections of the application.

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

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

All registrations must be successfully completed and active before the application due date.

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 HHS/CDC support.

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

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

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIOSH will not accept duplicate or highly overlapping applications under review at the same time. This means that 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).

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

The FOA governs new, renewal, and resubmission applications.

New: New applications are ones being submitted for the first time.

Renewals: Applicants may submit a renewal (formerly called a competing continuation) application for additional years of funding.

Resubmission: An unfunded application that has been modified following initial review can be resubmitted for new consideration.

As defined in the HHS Grants Policy Statement , applications received in response to the same 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

Applicants must download the SF424 (R&R) application package associated with this funding opportunity from http://www.Grants.gov.
If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the CDC Procurement and Grants Office Technical Information Management Section (TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am 4:30pm U.S. Eastern Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA.

Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate optional components. In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled PHS398. Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded from http://grants.nih.gov/grants/forms.htm.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Due Date for Letter of Intent: 01/20/2017

The letter of intent must be sent to:

Nina Turner, PhD
Scientific Review Officer
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1095 Willowdale Road
Mailstop G800
Morgantown, WV 26505-2845 USA
Telephone: 304-285-5976
Email: NTurner@cdc.gov

Mary Pat Shanahan
Grants Management Specialist
Office of Grant Services
Office of Financial Resources
Office of the Chief Operating Officer (OCOO)
Centers for Disease Control and Prevention
mpu0@cdc.gov 412-386-4453 office | 412-386-6429 fax

NIOSH will not accept any application that is essentially the same as one previously reviewed or currently pending initial merit review, unless the applicant withdraws the pending application.

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

• Number and title of this funding opportunity
• Name of the Applicant
• 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)
• Anticipated NIOSH collaborators, if any.

The LOI should also include a brief description of the proposed training program, the regional and national need for the proposed program, the burden of occupational injuries and illnesses within the region, and the anticipated impact that the program will have on improving miners safety and health

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

• Specific Aims section is limited to 1 page.
• The Research/Training Strategy (including tables, graphs, figures, diagrams, and charts) of the Research Plan narrative is limited to 25 pages.
• 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.

A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

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

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

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

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

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

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

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

The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here: http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf
for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).
Follow the page limits stated in the SF 424 (R&R) unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research/training and how it addresses the specific requirements of the FOA.

2. Specific Aims state the problem the proposed research/training addresses and how it will result in public health impact and improvements in population health.

3. Research/Training Strategy should be organized under the following 3 headings:

Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

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

All instructions in the SF424 (R&R) Application Guide

(http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf) must be followed along with any additional instructions provided in the FOA.

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

For this FOA, AR-25 Data Management and Access Policy will not apply. No public health data collection is anticipated or required for awards made under this FOA.

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 and training. The applicant can obtain guidance for completing a detailed justified budget at the following CDC website: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

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

Appendix materials in peer review
All information submitted with an application except the cover letter, assignment request form, and appendix information is assembled into a single application image for funding consideration. The different sections within the application image are specified in the application instructions and correspond to the standard review criteria.

Therefore,

• All information required for the peer review process must be contained within those designated sections of the application image, unless the Funding Opportunity Announcement (FOA) specifies otherwise.
• Information that expands upon or complements information provided in any section of the application -- even if it is not required for the review -- is not allowed in the appendix unless it is listed in the allowed appendix materials (below) (NOT-OD-11-080).
• Unless the FOA requires that certain information be included in the appendix, failure of reviewers to address appendix materials in their reviews is not an acceptable basis for an appeal of initial peer review (NOT-OD-11-064).

Allowable appendix materials
The only allowable appendix materials for this FOA are:

• Blank informed consent/assent forms
• Blank surveys, questionnaires, data collection instruments
• FOA-specified items
• A maximum of 10 PDF documents are allowed in the appendix.
• Up to 3 publications may be included that are not publically available.

Consequences for submitting disallowed appendix materials
Applications submitted with appendix materials that are not specifically listed in this Notice or the FOA as allowed or required will be withdrawn and not reviewed.

Examples of materials that can be submitted as appendix materials may include syllabi or key courses, core courses and electives; including courses in Responsible Conduct of Research, retreat, seminar series, and other program activity agendas, and schedules, examples of forms used to document trainee progress and monitoring by the program, examples of materials used in recruitment and particularly recruitment to enhance diversity of the applicant pool, lists of meetings attended by students and their presentations and student biosketches.

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 SF 424 (R&R) Application Guide.

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

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

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

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

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

Note: CDC/NIOSH grant submission procedures do not provide a period of time beyond the grant application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e. error correction window).

This initiative is not subject to intergovernmental review.

Awards may be issued with restrictions initially, until all requested information is received.

Generally, funds will not be given for renovation of existing facilities or for purchasing substantial amounts of equipment.

All CDC/NIOSH awards are subject to the federal regulations, 45 CFR 75, terms and conditions, and other requirements described in the HHS Grants Policy Statement. Expanded authorities are authorized under this FOA and will be specified in the grantee award notices issued under this FOA. For more information on expanded authorities, including pre-award costs, go to:

http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.

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

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

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

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to CDC. 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.

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

Critical Budget Requirement: Total costs for all subaward/consortium budgets must be counted as Direct Costs. Not complying with this critical budget preparation requirement may result in the requested budget exceeding the $450K direct cost cap and the application being considered nonresponsive.

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

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

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

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

Does the project address an important problem or a critical barrier to training miners in the Western United States? If the aims of the project are achieved, how will miner training be improved? How will successful completion of the aims change the concepts, methods, technologies, and services associated with miner training? Does the applicant institution have a record of related health and safety accomplishments for training development and delivery capacity? Is there a plan for interactions with other NIOSH-supported Miner Safety and Health Training Programs, organizations, and communities? Does the applicant document the following?

• Outcomes and impacts to be achieved
• The institution’s capacity in mining safety and health or train-the-trainer programs
• Effectiveness of its program delivery and dissemination.

For Renewal applications: In addition to the criteria above, is there sufficient information provided describing how the training program has achieved the goals of the previous funding period? Is there sufficient information on how the goals for future years build on the previous successes? Is there a plan for interactions with other NIOSH-supported Miner Safety and Health Training Programs, organizations, and communities? Does the applicant describe and provide evidence of the following?

• Recent outcomes and impacts achieved
• Adequate institutional capacity for and effectiveness in delivering programs in mining safety and health training or training the trainers.

Are the PD/PIs, collaborators, and other researchers or trainers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? Does the Principal Investigator strongly demonstrate the capacity (1) for providing leadership and assuring productivity of appropriate training and education programs for miner safety and health and (2) for overall management of the training programs, including quality assurance and program evaluation? Does the application describe a record of accomplishments that have advanced the field(s)? If the project is collaborative, do the investigators have complementary and integrated expertise, and are their leadership approach, governance, and organizational structure appropriate for the project? Does the application provide sufficient evidence of the following features?

• Experienced key personnel, with technical qualifications appropriate for this type of miner safety and health training
• Expertise in educational and communication sciences and practice, supporting adult-based education techniques and delivery
• An organizational structure providing adequate knowledge support to facilitate the program
• Lines of responsibility and accountability, clearly delineated when two or more organizations are collaborating on an activity
• Researchers/trainers with the skills and capacity to plan and execute a proactive training delivery subprogram, including new or existing channels of delivery and feedback (well beyond that of a passive, website-based delivery mechanism).

For Renewal applications, does the past performance reflect successful recruitment and retention of qualified, motivated trainers? (Success may be determined by the number of successful trainees, training courses taught, presentations, training materials developed, and relevant publications.)

With regard to the described concepts, approaches/methodologies, instrumentation, and/or interventions, (1) are they novel to one field of training or novel in a broad sense, or (2) do they represent a refinement, improvement, or new application of theoretical concepts, approaches, etc.? Are there innovative, active training activities, channels, and partners that increase the likelihood of successful delivery, such as access to mines, community and training halls, and nontraditional training venues such as Tribal facilities?

Are the overall strategy, methodology, translation and delivery, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? How adequate are the organization's or consortium's performance and effectiveness in planning, implementing, and operating appropriate miner safety and health training and education programs? Does the research/training plan describe use of appropriate, effective (and in various languages, if needed) adult education methods or techniques? Will these methods and techniques be used for identifying, describing, and accessing specific (target) worker populations? Are anticipated products and impact described, Are timeline or performance milestones measureable?

Is the detailed program plan adequate for miner safety and health training, with regard to the following characteristics?

• Adapting existing curricula
• Training instructors
• Distributing course materials
• Directing worker training
• Conducting program evaluations.

Does the application describe and/or provide evidence of the following features?

• Appropriate combinations of classroom or worksite instruction and hands-on demonstration/instruction that simulates site activities and conditions
• Train-the-trainer courses
• Ability to immediately initiate direct miner safety and health training, program evaluation, and related support activities
• Partnership agreements or procedures for assuring the long-term viability of the program
• Adequate plans for reaching underserved miner populations, especially those disadvantaged in education, culture, language, literacy, and/or access to training.

In addition, does the application define training and education needs that are specific to miners in the Western United States and provide supporting data from industry, unions, and miners? Does the applicant avoid overlap with existing training programs provided by MSHA and OSHA?

Does the applicant include a training evaluation plan that reflects appropriate evaluation questions, purposes, and methods for data collection, analysis, and reporting? Does the evaluation plan reflect the proposed project goals and objectives and utilize the most appropriate process and outcome measures to assess outputs and impacts? Does the application describe an evaluation plan to review and determine the quality, effectiveness, and short-term and long-term impacts of the training program? Will the plans for obtaining feedback from current and former trainees and for monitoring trainees career development and progression adequately measure the quality and effectiveness of the training program? Does the evaluation plan contain data related to tracking the productivity and effectiveness of training?

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

Will the training environment contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the proposed project? Will the project benefit from unique features in the training environment, types and experiences of miners, or collaborative arrangements? Are there appropriate facilities and equipment to support the described miner safety and health training and education activities, including hands-on instruction? Is there evidence that the operation of training facilities assures the protection of prospective trainees during program delivery? Are there appropriate policies and procedures for assuring fitness for training and medical clearance? Does the institution provide an adequate organization mission and adequate capacity for program evaluation?

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.

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

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

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

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the policy on the Inclusion of Women and Racial and Ethnic Minorities in Research (http:// www.cdc.gov /maso Policy /Policy_women.pdf and the policy on the Inclusion of Persons Under 21 in Research (http://aops-mas-iis.cdc.gov/Policy/Doc/policy496.pdf).

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.

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/dual-use/Pages/companion-guide.aspx.

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

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

Not applicable.

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.

A Special Emphasis Panel will evaluate complete, eligible applications in accordance with the criteria above.

Research to Practice

Reviewers will assess whether the applicant has demonstrated how their proposal addresses the research-to-practice initiative, particularly for training and education development and delivery to targeted miner groups.

Outcomes and Outputs

Reviewers will assess whether the applicant has provided sufficient information about the expected outcomes and outputs of the proposal and how this research and training will impact the field of occupational health and safety.

Data Management Plan

For this FOA, the CDC Data Management Plan is not required. The collection of public health data is not anticipated or required for awards made under this FOA.

Appendix materials

Examples of materials that can be submitted as appendix materials may include syllabi or key courses, core courses and electives; including courses in Responsible Conduct of Research, retreat, seminar series, and other program activity agendas, and schedules, examples of forms used to document trainee progress and monitoring by the program, examples of materials used in recruitment and particularly recruitment to enhance diversity of the applicant pool, lists of meetings attended by students and their presentations and student biosketches.

Not applicable.

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

HHS/CDC policy requires that recipients of grant awards make research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. Please see: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar25.

New additional requirement: CDC requires awardees 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.

A formal resource sharing plan (DMP) is not required.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research and training. The applicant can obtain guidance for completing a detailed justified budget at the following CDC website: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

Applications will be evaluated for scientific and technical merit by an appropriate peer review group, in accordance with CDC peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

• Will 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/priority score
• Will receive a written critique.

Applications will be assigned to NIOSH. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, applications will receive a second level of review. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographic balance (training sites).
• Proposed or current strength of partnerships (and delivery capacity potential) with NIOSH programs and other agencies, in terms of likelihood of new synergy and impact.
• Availability of funds.

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 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. The evaluation criteria is described in this funding opportunity announcement.

In evaluating risks posed by applicants, CDC will use a risk-based approach and may consider any items such as the following:

(1) Financial stability;

(2) Quality of management systems and ability to meet the management standards prescribed in this part;

(3) History of performance. The applicant's record in managing federal awards, if it is a prior

recipient of federal awards, including timeliness of compliance with applicable reporting requirements, conformance to the terms and conditions of previous federal awards, and if applicable, the extent to which any previously awarded amounts will be expended prior to future awards;

(4) Reports and findings from audits performed under subpart F 45 CFR 75 or the reports and findings of any other available audits; and

(5) The applicant's ability to effectively implement statutory, regulatory, or other requirements imposed on non-federal entities.

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

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

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

Any applications awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements. If the application is under consideration for funding, HHS/CDC will 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.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. Expanded authorities are authorized under this FOA and will be specified in the grantee award notices issued under this FOA.

All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of Award (http://www.hrsa.gov/grants/hhsgrantspolicy.pdf).

Awardees must comply with the administrative requirements (AR) outlined in 45 Code of Federal Regulations (CFR) Part 75, as appropriate, as well as any additional requirements included in the FOA.

Specific requirements that apply to this FOA are the following:

Generally applicable ARs:

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 2010

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

For this FOA, AR-25 Data Management and Access will not apply. No data collection is anticipated and required for awards made under this FOA.

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

For more information on the Code of Federal Regulations, visit the National Archives and Records Administration at: http://www.archives.gov/.

To view brief descriptions of relevant CDC requirements visit: http://www.cdc.gov/grants/additionalrequirements/index.html.

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 apply to all new obligations and all funds appropriated by Congress. For more information, visit the HHS website at: http://www.hhs.gov/grants/contracts/contract-policies-regulations/efficient-spending/index.html.

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

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

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

Tobacco:

• Tobacco-free indoors no use of any tobacco products (including smokeless tobacco) or electronic cigarettes in any indoor facilities under the control of the applicant.
• Tobacco-free indoors and in adjacent outdoor areas no use of any tobacco products or electronic cigarettes in any indoor facilities, within 50 feet of doorways and air intake ducts, and in courtyards under the control of the applicant.
• Tobacco-free campus no use of any tobacco products or electronic cigarettes in any indoor facilities and anywhere on grounds or in outdoor space under the control of the applicant.

Nutrition:

• Healthy food service guidelines that at a minimum align with Health and Human Services and General Services Administration Health and Sustainability Guidelines for Federal Concessions and Vending Operations for cafeterias, snack bars, and vending machines in any facility under the control of the recipient organization and in accordance with contractual obligations for these services. The following are resources for healthy eating and tobacco free workplaces:
• http://www.gsa.gov/graphics/pbs/Guidelines_for_Federal_Concessions_and_Vending_Operations.pdf
• http://www.cdc.gov/nccdphp/dnpao/hwi/toolkits/tobacco/index.htm
• http://www.cdc.gov/chronicdisease/pdf/guidelines_for_federal_concessions_and_vending_operations.pdf

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

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

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

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

Language Access for Persons with Limited English Proficiency Recipients of federal financial assistance from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. Recipients of federal financial assistance must take 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. Grantees (foreign and domestic) receiving CDC funding on or after September 24, 2015 are subject to this policy. Research funded by CDC involving the agents or toxins named in the policy, must be reviewed to determine if it involves one or more of the listed experimental effects and if so, whether it meets the definition of DURC. This review must be completed by an Institutional Review Entity (IRE) identified by the funded institution.

Recipients also must establish an Institutional Contact for Dual Use Research (ICDUR). The award recipient must maintain records of institutional DURC reviews and completed risk mitigation plans for the term of the research grant, cooperative agreement or contract plus three years after its completion, but no less than eight years, unless a shorter period is required by law or regulation. If a project is determined to be DURC, a risk/benefit analysis must be completed. CDC will work collaboratively with the award recipient to develop a risk mitigation plan that the CDC must approve. The USG policy can be found at http://www.phe.gov/s3/dualuse.

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

Federal Information Security Management Act

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

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 http://www.cdc.gov/grants/additionalrequirements/index.html#ui-id-49 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

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 awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; CDC Project Officer 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and HHS/CDC as defined below.

Principal Investigator (PI)

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

• Retain custody of and having 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.
• Define objectives and approaches and how to plan, conduct, analyze, and evaluate awardees training activities.
• Develop the details of the research/training plan, which will be required to describe the technical approaches, target population, access and recruitment, curricula modification, training methodology, and program evaluation.
• Meet annually with NIOSH Scientific Program Official and NIOSH Project Scientist to review progress, share information, and coordinate training activities. For budget preparation, assume a full 1-day meeting in either Atlanta, GA, or Pittsburgh, PA. Assume two nights of lodging are needed.
• Before use, submit draft copies of training manuals, instructor guides, course curricula, and other materials developed for use in training activities supported by NIOSH to the Scientific Program Official and Project Scientist for technical comments and suggestions regarding the adequacy, technical accuracy, and suitability of materials for miner training and education. Transmit to NIOSH, in approved electronic format, the final copies of all materials developed with support from NIOSH and made available to the general public, subject to any specific legal caveats on use or copyright protection. Report is to be Federal Law 508 compliant for public use.
• Assign an individual the responsibility for information technology transfer and dissemination, to ensure effective communication and transfer of important training and administrative information to NIOSH. Such information may include trainee-related data, computation and submittal of training data, coordination of special meetings or conferences, submittal of training materials, and other training activities conducted by the program.

NIOSH Scientific Program Official

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

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

• Ensure that all requirements are met prior to issuance of an initial award.
• Objectively and independently evaluate progress toward specific aims or objectives, approving noncompetitive continuation of the award.
• Recommend corrective actions as needed.
• Monitor and evaluate the activities, performance, and accomplishments of the recipient through conference calls, site visits, and review of project reports.
• Receive, review, and comment on draft materials and plans consistent with the section description immediately below, such as training materials, evaluation plan, and tools.
• Carry out administrative, scientific, and technical related duties such as grant cycle or funding information; programmatic approvals and recommendations; and consultation or technical assistance pertaining to administration requirement of award. Monitor and process Just-In-Time (JIT) information for research projects; approve final reports before release and distribution; communicate guidance and policy; facilitate budget recommendations; and disseminate grantee information such as the Annual Report and research reports.
• Provide guidance or information for addressing recipient inquiries.
• JOINTLY convene a 1-day workshop meeting annually with grantees in cooperation with the NIOSH Project Scientist to review and share grantee information and products, discuss technical and coordination plans or issues, build partnership among the funded institutions, and coordinate partnership and/or training activities.

NIOSH Project Scientist (Mining)

A NIOSH scientist may serve as a Project Scientist to provide substantial subject matter expertise to assist the NIOSH Scientific Program Official. Specific responsibilities, in coordination with the NIOSH Scientific Program Official, may include the following:

• Provide technical assistance to grantees in support of their leadership and responsibility for Western mine workers health.
• Coordinate collaboration between NIOSH and the awardees in the creation of miner safety and health programs.
• Assess duplication of efforts in miner safety and health training delivery and program development by the awardees.
• Help ensure consistent use and delivery of existing miner safety and health training materials.
• Review educational and training materials developed by the awardees for consistency, appropriateness, and technical accuracy.
• Provide technical assistance to awardees for evaluating the impact of the training on improving work practices, reducing work-related injury and illness, and increasing the understanding of safety and health practices in mining environments.
• Assist with assessing overall effectiveness of the miner training programs supported by this FOA; discuss at annual workshops.
• Engage in quarterly communications with the grantees and the NIOSH Scientific Program Official.
• Assist NIOSH Scientific Program Official with convening a 1-day workshop meeting annually with grantees, to review and share grantee information and products, discuss technical and coordination plans or issues, build partnership among the funded institutions, and coordinate partnership and/or training activities.

Each awardee is required to submit an Annual Report to the NIOSH Program Official and the NIOSH Project Scientist. The report is submitted by September 30 each year, or the next business day. This should include the number, location, and nature of all training activities and the characteristics of the trainees reached during a particular budget period. Results and findings from training program evaluations will be summarized by each awardee and submitted on an annual basis. To the extent feasible, the program evaluation reports shall quantitatively describe the current status of instructor effectiveness, trainee retention of knowledge and skills, and positive impacts of training activities on work practices, workplace safety and health conditions, and overall worker protection from on-the-job hazards. The annual report should also include narrative descriptions of high-impact outcomes of individual programs that are noteworthy. Specific guidance on report content will be provided by NIOSH.

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement (http://www.hrsa.gov/grants/hhsgrantspolicy.pdf).
A final progress report, invention statement, equipment inventory list and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of federal grants to report information about first-tier subawards and executive compensation under federal assistance awards issued in FY2011 or later. Compliance with this law is primarily the responsibility of the federal agency. However, two elements of the law require information to be collected and reported by recipients: 1) information on executive compensation when not already reported through the SAM Registration; and 2) similar information on all sub-awards/ subcontracts/ consortiums over $25,000. It is a requirement for awardees of federal grants to report information about first-tier subawards and executive compensation under federal assistance awards issued in FY2011 or later. All awardees 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 (http://www.hrsa.gov/grants/hhsgrantspolicy.pdf) for additional information on this reporting requirement.

The Recipient Organization must provide HHS/CDC with an original, plus one hard copy of the following reports:

• Yearly Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHS/CDC website, www.grants.gov and at http:// grants.nih.gov/grants/ funding/2590/ 2590.htm), is due 90 to 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application. Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the federal government.
• Annual Federal Financial Report (FFR) SF 425 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.
• A final progress report, invention statement, equipment/inventory report, and the final FFR are required 90 days after the end of the project period.

1. Yearly Non-Competing Grant Progress Report: The grantee s continuation application/progress report should include:

• Description of Progress during Annual Budget Period: Current Budget Period Progress reported on the PHS 2590 (http:// grants1.nih.gov/ grants/funding/ 2590/2590.htm)
  http:// grants.nih.gov/grants/ funding/2590/2590.htm: Detailed narrative report for the current budget period that directly addresses progress towards the Measures of Effectiveness included in the current budget period proposal.
• Research Aims: list each research aim/project
• Research Aim/Project: purpose, status (met, ongoing, and unmet), challenges, successes, and lessons learned
• Leadership/Partnership: list project collaborations and describe the role of external partners.
• Translation of Research (1 page maximum). When relevant to the goals of the research project, the PI should describe how the significant findings may be used to promote, enhance, or advance translation of the research into practice or may be used to inform public health policy. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. The PI should identify the research findings that were translated into public health policy or practice and how the findings have been or may be adopted in public health settings. Or, if they cannot be applied yet, this section should address which research findings may be translated, how these findings can guide future research or related activities, and recommendations for translation. If relevant, describe how the results of this project could be generalized to populations and communities outside of the study. Questions to consider in preparing this section include:
• How will the scientific findings be translated into public health practice or inform public health policy?
• How will the project improve or effect the translation of research findings into public health practice or inform policy?
• How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in public health programs or practices?
• How will the findings advance or guide future research efforts or related activities?
• Public Health Relevance and Impact (1 page maximum). This section should address improvements in public health as measured by documented or anticipated outcomes from the project. The PI should consider how the findings of the project relate beyond the immediate study to improved practices, prevention or intervention techniques, inform policy, or use of technology in public health. Questions to consider in preparing this section include:
• How will this project lead to improvements in public health?
• How will the findings, results, or recommendations been used to influence practices, procedures, methodologies, etc.?
• How will the findings, results, or recommendations contributed to documented or projected reductions in morbidity, mortality, injury, disability, or disease?
• Current Budget Period Financial Progress: Status of obligation of current budget period funds and an estimate of unobligated funds projected provided on an estimated FFR.
• New Budget Period Proposal:
• Detailed operational plan for continuing activities in the upcoming budget period, including updated Measures of Effectiveness for evaluating progress during the upcoming budget period. Report listed by Research Aim/Project.
• Project Timeline: Include planned milestones for the upcoming year (be specific and provide deadlines).
• New Budget Period Budget: Detailed line-item budget and budget justification for the new budget period. Use the CDC budget guideline format.
• Publications/Presentations: Include publications/presentations resulting from this CDC grant only during this budget period. If no publication or presentations have been made at this stage in the project, simply indicate Not applicable: No publications or presentations have been made."
• IRB Approval Certification: Include all current IRB approvals to avoid a funding restriction on your award. If the research does not involve human subjects, then please state so. Please provide a copy of the most recent local IRB and CDC IRB, if applicable. If any approval is still pending at time of APR due date, indicate the status in your narrative.

This report will be made available on the NIOSH web page and will be used to provide information on mining training activities to the Congress, the public, and others.

• Successes: A description of progress on completing activities outlined in the work plan and any additional successes achieved in the past year (identified through evaluation results or lessons learned, for instance).
• Challenges: A description of any challenges that might affect the ability to achieve annual and project-period outcomes, conduct performance measures, or complete the activities in the work plan, plus additional challenges encountered in the past year (identified through evaluation results or lessons learned, for instance).
• Outputs, Outcomes, and Research to Practice (r2P): Provide in the purpose section of each progress report; a brief statement about expected outputs, outcomes, and/or r2p culmination of the proposed project.

Outputs are the products of the research project activities. Examples include publications, reports, conference proceedings, presentations/posters, databases, tools, methods, guidelines, recommendations, education and training materials, inventions, and patents.
An intermediate outcome is what a stakeholder does with the knowledge or products generated by the research project to contribute to end outcomes (reductions in workplace illnesses, injuries, fatalities, and/or hazardous exposures). Intermediate outcomes include public or private policy changes, conduct of training or workshops based on project outputs, self-reported use or repackaging of research data, adoption of technologies or methods developed by NIOSH, implemented guidelines, and changes in workplace behaviors by either employers or employees.

Research to Practice is the transfer and translation of knowledge, interventions, and technologies into highly effective prevention practices and products that are adopted in the workplace.

2. Annual Federal Financial Reporting

The 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. All CDC Financial Expenditure data due on/after October 1, 2012 must be submitted using the FFR via the eFSR/FFR system in the eRA Commons. All Federal Reporting in the Payment Management System is unchanged. All new submissions should be prepared and submitted as FFRs.

CDC's implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 1/30/2012, the annual FFR is due 6/30/2012 (90 days after the end of the calendar quarter of 3/31/2012). Due dates of final reports will remain unchanged. The due date for final FFRs will continue to be 90 days after the project period end date.
Grantees must submit closeout reports in a timely manner. Unless the Grants Management Officer (GMO) of the awarding Institute or Center approves an extension, grantees 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 grantees are now available at http:// grants.nih.gov/ grants/forms.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://era.nih.gov/registration_accounts.cfm
FFR Submission: The submission of FFRs to CDC will require organizations to register with eRA Commons (Commons) (https:// commons. era.nih.gov/ commons/). CDC recommends that this one time registration process be completed at least 2 weeks prior to the submittal date of a FFR submission.

Organizations may verify their current registration status by running the List of Commons Registered Organizations query found at: https://era.nih.gov/registration_accounts.cfm. Organizations not yet registered can go to https:// commons. era.nih.gov/ commons/ registration/registration Instructions.jsp for instructions. It generally takes several days to complete this registration process. This registration is independent of Grants.gov and may be done at any time.

The individual designated as the PI on the application must also be registered in the Commons. The PI must hold a PI account and be affiliated with the applicant organization. This registration must be done by an organizational official or their delegate who is already registered in the Commons. To register PIs in the Commons, refer to the eRA Commons User Guide found at: http://era.nih.gov/ commons/index.cfm.

3. Final Reports: Final reports should provide sufficient detail for CDC to determine if the stated outcomes for the funded research have been achieved and if the research findings resulted in public health impact based on the investment. The grantee’s final report should include:

• Research/Training Aims and Project Overview: The PI should describe the purpose and approach to the project, including the outcomes, methodology and related analyses. Include a discussion of the challenges, successes and lessons learned. Describe the collaborations/partnerships and the role of each external partner.
• Translation of Research Findings: The PI should describe how the findings will be translated and how they will be used to inform policy or promote, enhance or advance the impact on public health practice. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers and other potential end users. The PI should also provide a discussion of any research findings that informed policy or practice during the course of the project period. If applicable, describe how the findings could be generalized and scaled to populations and communities outside of the funded project.
• Public Health Relevance and Impact: This section should address improvements in public health as measured by documented or anticipated outcomes from the project. The PI should consider how the findings of the project related beyond the immediate study to improved practices, prevention or intervention techniques, or informed policy, technology or systems improvements in public health.
• Publications; Presentations; Media Coverage: Include information regarding all publications, presentations or media coverage resulting from this CDC funded activity. Please include any additional dissemination efforts that did or will result from the project.

Specific guidance for the final report is available on the NIOSH OEP website, Closeout Report Guide.

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

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

eRA Commons Help Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)

CDC Technical Information Management Section (TIMS)
Telephone 770-488-2700
Email: PGOTIM@cdc.gov
Hours: Monday - Friday, 7am 4:30pm U.S. Eastern Time

Maria Lioce, MD
Scientific Program Official
Centers for Disease Control and Prevention
CDC/NIOSH/OEP
1600 Clifton Road NE, Mailstop E74
Atlanta, GA 30329-4018
Telephone: 404-498-2575
Email: MLioce@cdc.gov

Peer Review Contact(s)

Nina Turner, PhD
Scientific Review Officer
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention.
1095 Willowdale Road
Mailstop G800
Morgantown, WV 26505-2845 USA
Telephone: 304-285-5976
Email: NTurner@cdc.gov

Mary Pat Shanahan
Grants Management Specialist
OD, Environmental, Occupational Health and
Injury Prevention Services Branch Team 1
Procurement and Grants Office
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Phone: 412-386-4453
Fax: 412-386-6429
Email: MShanahan@cdc.gov

Other CDC funding opportunity announcements can be found at www.grants.gov .

Recently issued NIOSH policy notices may affect your application submission. A full list of policy notices published by NIOSH 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 HHS Grants Policy Statement (http://www.hrsa.gov/grants/hhsgrantspolicy.pdf)

Awards are made under the authorization of Sections of the Public Health Service Act as amended and under the Code Federal Regulations.

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