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

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

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



Table of Contents

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

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

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

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

Background

Every day, millions of U.S. workers go to their jobs, expecting to return home healthy and safe. The workplace environment can have a significant impact on a worker’s physical and psychological health. Depending on the job, a worker may be at risk for many different kinds of injuries and illnesses or even death. Work-related illnesses are often significantly underestimated because of the difficulty of recognizing or associating illness or disease with past occupational exposures. In 2016, private industry employers reported approximately 2.9 million nonfatal workplace injuries and illnesses, according to estimates from the Survey of Occupational Injuries and Illnesses (SOII) conducted by the U.S. Bureau of Labor Statistics (BLS). In addition, a report from the Census of Fatal Occupational Injuries (CFOI) by the BLS indicates that there were 5,190 fatal work injuries in the United States in 2016. Work-related injuries, illnesses, and deaths are very costly to American society. In 2015, employers spent $94.8 billion on workers' compensation (National Academy of Social Insurance Data). Despite successes in reducing fatal and nonfatal occupational-related injuries and illnesses in recent years, the need for continued research and intervention activities in occupational safety and health (OSH) remains essential.

Purpose

The National Institute for Occupational Safety and Health (NIOSH) is an agency operating under the Centers for Disease Control and Prevention (CDC), with the mission of generating new knowledge in the field of occupational safety and health and transferring that knowledge into practice to prevent worker injury, illness, and death. To accomplish this mission, NIOSH conducts and funds scientific research; develops methods to prevent occupational hazards; develops guidance and authoritative recommendations; translates scientific knowledge into products and services; disseminates information; identifies factors underlying work-related disease and injury; and responds to requests for workplace health hazard evaluations. To learn more about NIOSH, visit About NIOSH.

NIOSH organizes its research programs into sector and cross-sector programs based on the framework provided by the National Occupational Research Agenda (NORA), a partnership program designed to stimulate innovative research and improved workplace practices.

NIOSH supports research objectives such as the following:

• identification and investigation of the relationships between hazardous working conditions and associated occupational diseases and injuries;
• development of more sensitive means of evaluating hazards at work sites;
• development of methods for measuring early markers of adverse health effects and injuries;
• development of new protective equipment and engineering control technology to reduce work-related illnesses and injuries;
• development of work practices that reduce the risks of occupational hazards; and
• evaluation of the technical feasibility or application of new or improved occupational safety and health procedures, methods, techniques, or systems, including assessment of economic and other factors that influence their diffusion and successful adoption in workplaces.

The K01 grant mechanism provides "protected time" for an intensive, supervised (mentored) career development experience in occupational health and safety research. This can facilitate the transition of junior research scientists from the mentored to the independent stages of their careers in occupational health and safety research. By providing support for the critical transition period between postdoctoral training and independent R01 funding for investigators, NIOSH hopes to foster the careers of these investigators, who are vital for the future excellence of occupational safety and health research endeavors. Applicants must justify the need for a period of mentored research experience and convincingly describe how the proposed period of support will substantially enhance their careers as independent investigators.

Healthy People 2020 and other National Strategic Priorities

The United States Public Health Service (PHS) is committed to achieving nationwide improvements in health for a society in which all people live long, healthy lives. The vision, mission, and goals are found in Healthy People 2020 at 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 programs is to support relevant, high quality, and effective projects that demonstrate impact in reducing occupational disease and injury. Detailed information about the NORA Program Portfolio can be found at http://www.cdc.gov/niosh/programs/.

Public Health Impact

NIOSH programs support research that addresses worker safety, accident prevention, and health concerns across a wide spectrum of industries and occupations, and approaches. The approaches include basic research through translation research. The latter approach takes research knowledge and puts it to use by promoting engineering controls, new technologies, and communication products. Through this announcement, NIOSH encourages qualified applicants to submit applications that will reduce or prevent occupational injury, illness, and death. These applications can be targeted to particular worker populations or to workers in broad spectrums of the work environment.

Relevant Work

NIOSH has a long history of funding extramural research covering a highly diverse range of topics and approaches related to occupational safety and health research. Ongoing funding opportunities such as described in this announcement provide grant support for investigator-initiated research, small research projects, exploratory developmental research, and/or career-development awards for mentored research scientists. Through funding in these areas, NIOSH successfully supports advancements in knowledge in the field of occupational safety and health and the transfer of knowledge into practice. More information can be found at the NIOSH Office of Extramural Programs.

2. Approach

NIOSH organizes its research program under the framework of the National Occupational Research Agenda (NORA). NORA is a partnership program to stimulate innovative research and improved workplace practices. Unveiled in 1996, NORA is now entering its third decade (2016 2026) with an enhanced structure. It now consists of ten industry sectors based on major areas of the U.S. economy, and seven health and safety cross-sectors organized according to the major health and safety issues affecting the U.S. working population.

NIOSH has developed a strategic plan for research for fiscal years 2019-2023 that identifies strategic and intermediate goals for its research portfolio (https://www.cdc.gov/niosh/about/strategicplan/). The strategic goals listed below represent the major health and safety issues facing the U.S workforce. These goals are the broad focus areas for this funding opportunity.

Strategic Goals

• Reduce occupational cancer, cardiovascular disease, adverse reproductive outcomes, and other chronic diseases.
• Reduce occupational hearing loss.
• Reduce occupational immune, infectious, and dermal disease.
• Reduce occupational musculoskeletal disorders.
• Reduce occupational respiratory disease.
• Improve workplace safety to reduce traumatic injuries.
• Promote safe and healthy work design and well-being.

Intermediate Goals

NIOSH has also identified intermediate goals. These are specific actions needed to achieve, or help achieve, the strategic goals. In addition, NIOSH has identified certain areas where extramural research is specifically encouraged to fill a gap or provide a capacity that NIOSH cannot. Descriptions and updates of the strategic and intermediate goals are on the NIOSH website at https://www.cdc.gov/niosh/about/default.html.

Note to Applicants

Consider the NIOSH strategic plan carefully as you develop proposals and identify the strategic and intermediate goals the proposed research will support. Funding priority will be given to those applications that clearly address strategic and intermediate goals.

Researchers are encouraged to use innovative or novel approaches as they develop their research proposal to address the major health and safety issues facing the U.S. workforce and move the field forward through action designed to achieve these strategic and intermediate goals.

NORA Sectors and Health and Safety Cross-sectors

In the Project Description/Abstract, state which industry sector(s) and health and safety cross-sector(s) the proposed work will address. Provide a clear rationale for how the intended outcomes of the proposed project will contribute to the specified strategic and intermediate goals.

Funding priority will be given to applications that clearly identify the strategic and intermediate goals their proposed work will address or support.

Note to Applicants

Review the following websites for updates about NIOSH strategic and intermediate goals, research goal priorities, and other current information as you craft and submit your research proposals:

• National Occupational Research Agenda (NORA) - https://www.cdc.gov/niosh/nora.
• NIOSH Strategic Goals - https://www.cdc.gov/niosh/about/default.html.
• NIOSH Programs - https://www.cdc.gov/niosh/programs.html.
• NIOSH Office of Extramural Programs - https://www.cdc.gov/niosh/oep.

This information is provided to help researchers submit relevant, high-quality applications.

Burden, Need, and Impact

The third decade of NORA encompasses a new framework for assessing research priorities and aligning NIOSH research investments. This new framework provides a structured, transparent, evidence-based approach that considers the following:

• the burden of occupational exposures and hazards on worker morbidity, mortality, injury, and direct and indirect economic costs;
• the need for the research effort, including the comparative advantage that NIOSH embodies; and
• and the potential for impact of the proposed research.

This new burden-need-impact framework is known by its acronym, BNI. Research funded under this FOA will advance the strategic and intermediate goals of the NIOSH Strategic Plan based on BNI. The concepts of the new BNI framework are as follows:

Burden

Burden is risk from any of the following: exposure to hazards; occurrence of injuries, illnesses, or deaths due to work-related factors; and impacts on economic factors and well-being. The extent of exposure can be in terms of the number of workers exposed, the magnitude of the exposure, or both. The assessment of burden is based on several main constructs: magnitude of the problem; health impact severity; exposure to workers; societal costs; new or emerging issues; and relationship to work environment. For emerging issues, the burden is anticipatory.

Note to Applicants

• Clearly describe the occupational health burden(s) your research will address and how the proposed research activities and outputs will help alleviate these burdens.
• Estimate potential burden by using the same arguments as for existing burden, and identify any assumptions.
• Provide a rationale for extrapolating potential burden to the population at risk.

Address the following elements of burden:

• Exposure/Hazard. How many workers are exposed or at risk? Are there disparities among worker populations? Is there a trend in exposure or risk? Does a new or emerging burden show an increasing trend?
• Injury/Illness. How many fatalities or illnesses have occurred? What is the incidence or prevalence of the injury or illness? Are there disparities among worker populations?
• Disability/Severity. How serious is the health outcome under study? Is there evidence of disability, years of life lost or disabled, reduction in quality of life, or days away from work? Have the most relevant indicators been selected?
• Cost. What is the estimated cost (such as medical expenses), productivity loss (such as absenteeism or presenteeism), wage loss, or disability payment(s)? Have the most relevant indicators been selected?
Need

Although burden is a foundational factor in setting priorities, need is also a critical factor. NIOSH strives not only invest in an important burden area but also to focus on the most relevant and impactful issues pertaining to that burden.

Note to Applicants

Address the following elements of need:

• Evidence of knowledge gap. Is there evidence that this activity will address a knowledge gap?
• Methodological approach. Is the proposed research method well defined (basic/etiologic, intervention, translation, or surveillance) and appropriate to the proposed aims of the project? How does this methodological approach compare with other approaches that could be considered to fill the knowledge gap?
• Time fit. Is this the best time for undertaking this activity?
• Stakeholder need. Does this study address an explicit stakeholder need? What is the evidence of that need and why should NIOSH address the need? What are the potential advantages of NIOSH undertaking this activity, in the broad context of research, policy, and practice?
Impact

The assessment of impact is based on the potential for the activity to be successful in generating knowledge or products that will be used by stakeholders external to NIOSH (intermediate outcomes).

Note to Applicants

Describe how these intermediate outcomes might result in reduced burden or improved health and well-being in the near- or long-term. Describe who will benefit from the proposed activities. Include appropriate partners or stakeholders in the activities to help ensure successful transfer of the findings to the end users or intended audience.

Address the following elements of impact:

• Likelihood of success. What is the probability of success? Is the proposed research feasible and likely to address the stated need? Feasibility includes available capacity, resources, and technical expertise, as well as anticipated time to completion. If relevant, are letters of support from collaborators, stakeholders, or critical data sources provided?
• Use or dissemination of research results by others. Is there potential for the proposed research to be used in setting standards, guidance, policy, or recommendations? Could the proposed research be adopted by manufacturers, trade associations, or others? Is there potential for dissemination of research results by external organizations? Is there potential for others to adopt technology, training programs/materials, intervention strategies, or new surveillance methods used in or resulting from the proposed research? Is there a potential for technology to be transferred into the marketplace? If appropriate to the proposed research, is there potential for partners to assist in tracking progress of research translation efforts?
• Follow-on research. Is the proposed research likely to generate information that leads to follow-on research that builds on the findings from this project? What type of follow- on research would be anticipated as a follow-up?
Data Resources

NIOSH has a number of data resources are available to researchers at the NIOSH Data and Statistics Gateway (https://www.cdc.gov/niosh/data/default.html). This includes Worker Health Charts (https://wwwn.cdc.gov/NIOSH-whc) that use worker health data gathered by NIOSH from the Bureau of Labor Statistics to create specialized charts to assess the rates, distribution, and trends in workplace injuries, illnesses and deaths. These data can be used to help provide the context and estimate the burden of the problems being addressed, the need for the proposed work, the impact on the workforce, and the potential long-term benefits of the proposed projects and activities. Additionally, issues can be contextualized through economic metrics such as the societal cost, medical cost, productivity losses and disability costs.

Research to Practice

In addition to NORA, NIOSH has established a Research to Practice (r2p) approach to reduce or eliminate occupational illness and injury. This r2p approach increases the transfer and translation of knowledge, interventions, and technologies into highly effective prevention practices and products into the workplace. It involves collaborations with partners and stakeholders on the use, adoption, and

adaptation of NIOSH knowledge, interventions, and technologies that will move research into practice in order to reduce and eliminate injuries, illness, and fatalities. The r2p approach is an interactive process in which the occupational safety and health community including researchers, communicators, decision-makers, and employer/employee groups works collaboratively to:

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

Note to Applicants

In both the Description (Abstract) and the Research Strategy (Significance) section of your application, briefly state how the proposed research addresses r2p.

Objectives

Proposed goals and objectives should be clearly stated in the application and directly linked to the occupational health and safety burdens being addressed. Applicants are expected to justify their proposal by describing the burden of the problem, the need for the proposed research or activity, and the potential for impact or likelihood of success.

Provide data to support your selection of the proposed work, such as morbidity or mortality rates and indicators of the size of the population at risk (including estimates of the target population’s potential risk of exposure to the hazard, frequency of exposure, or sociodemographic factors such as age, gender, and race/ethnicity). Similarly, provide qualitative data that describe exposures, the magnitude of the problem, and potential benefits and impacts of addressing the issue. Qualitative data may be necessary when the nature of the exposure or population at risk makes it difficult to collect large-scale, representative quantitative data.

Outputs and Outcomes

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

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

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

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

Note to Applicants

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

Target Population

The ultimate beneficiaries are workers in the United States. As an example, a project might target vulnerable U.S. worker populations to address increased safety and health risks associated with occupational health disparities, changing worker demographics, and the changing nature of work. The population(s) of workers to be addressed by the proposed research should be identified, whether specifically or more broadly.

Collaborations/Partnerships

Partnerships are critical for translating research findings into effective work practices and are encouraged by the NIOSH Research-to-Practice (r2p) program. Interdisciplinary and trans-disciplinary collaborations that share expertise are essential to advancing occupational safety and health (OSH).

Note to Applicants

Address a wide range of occupational safety and health concerns, as determined by the burdens posed by these concerns, and describe how your efforts will alleviate or eliminate these burdens. Include collaborations or partnerships that strengthen the proposed research in terms of OSH, or related, expertise and resources.

Evaluation/Performance Measurement

Evaluations provide information for management and improve program effectiveness. The following CDC document A Framework for Program Evaluation may be helpful.

Effective program evaluation is a systematic way to improve and account for public health actions by involving procedures that are useful, feasible, ethical, and accurate. Understanding and applying the elements of this framework for research projects may enhance planning effective public health strategies, improving existing programs including evidence-based activities, and demonstrating beneficial results and impact of federal funding.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

Awards issued under this FOA are contingent upon availability of funds and receipt of a sufficient number of meritorious applications.

Total amount awarded and the number of awards issued each year will depend upon available funds and the number, quality, duration, and proposed costs of the applications received.

Anticipated number of awards per year is 3 to 5.

The estimated total funding (direct and indirect costs) available for new awards each year is $500K.

Estimated total funding (direct and indirect) available for these awards over a 3-year performance period is $1.5M.

This FOA covers a 5-year period. Available funds may vary each year.

Award Budget

Award budgets are composed of salary and other program-related expenses, as described below, and cannot exceed $100,000 in direct costs per budget period (including consortium F&A costs).

Applicants can request varying support levels for salary and other program-related expenses. However, the sum of these direct costs cannot exceed $100,000 per budget period.

Indirect costs are limited to 8%. Therefore, the maximum total costs budget allowed for a 3-year period of performance is $324,000.

Award Project Period

The total period of performance may not exceed 3 years.

Other Award Budget Information
Salary

The total amount requested for salary and other program-related expenses cannot exceed $100,000 direct costs per budget period. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide.

The total salary may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.

Other Program-Related Expenses

The total amount requested for other program-related expenses and salary cannot exceed $100,000 direct costs per budget period.

Salary for mentors, secretarial and administrative assistants is not allowed.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

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

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

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

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

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The 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.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC support. Multiple PDs/PIs are not allowed.

Applicants must have a research or health-professional doctoral or medical degree.

Applicants may have only one individual Career Development Award application pending peer review at any time. Awards are not renewable and are not transferable from one PD/PI to another.

A candidate for a NIOSH K01 Award may not simultaneously submit or have under review an application for any other PHS award that duplicates or highly overlaps with the provisions of the NIOSH K01 award. Current principal investigators on CDC/NIOSH or NIH awards are not eligible.

Applicants for the K01, under some circumstances, may have been principal investigators on CDC/NIOSH or NIH research or career development awards and are still eligible for this award, provided the research experience proposed in the K01 application is in a fundamentally new field of study. Applicants are therefore strongly encouraged to contact the NIOSH Scientific/Research Contact listed in Section VII prior to preparing an application, to discuss issues of eligibility, program relevance, and specific provisions of this award.

At the time of award, the candidate must have a full-time appointment at the applicant institution. NIOSH does not require applicants to be on a tenure track for K01 eligibility. Candidates may not consider Veterans Affairs (VA) appointments in satisfying the full-time status requirement at the applicant institution. Candidates with VA appointments should contact the NIOSH Scientific/Research Contact listed in Section VII prior to preparing an application to discuss their eligibility.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (that is, possess a currently valid Permanent Resident Card [USCIS Form I-551], or other legal verification of such status).

K01 award recipients are encouraged to obtain funding from CDC, NIOSH, NIH, or other federal sources either as a named PD/PI on a competing research grant award or cooperative agreement or as a sub-project director on a competing multi-project award. At the time the research grant is awarded, the effort required on the K01 award may be reduced to no less than 6 person-months (50% full-time professional effort) at the grantee organization and replaced by effort from the other research award so that the total level of research commitment remains at 9 person-months (75% full-time professional effort) or more for the duration of the K01 award. See NOT-OD-08-065 and NOT-OD-09-036 for more details.

For a K01 awardee to be eligible for salary support from other peer-reviewed research awards from any federal agency:

• The K01 awardee must be the PD/PI (or one of the named PD/PIs on a project following the multiple-PD/PI model) on a competing research grant application (R01, R03, R21, or equivalent application from another federal agency) or a sub-project director on a competing multi-component research or center grant or cooperative agreement application (P01, P50, U01, U50, U60, etc., or an equivalent application from another federal agency)
• The K01 award must be active when the competing research grant application is submitted
• The K01 award must be in its final two years before the reduction in effort to 6 person-months (50% full-time professional effort) is permitted.
2. Cost Sharing

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

Level of Effort

At the time of award, the candidate must have a full-time appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development during the project period. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

Candidates who have Veteran Affairs appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to CDC/NIOSH seeking a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Mentor(s)

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research.

Candidates are encouraged to identify more than one mentor, i.e., a mentoring team (or advisory committee), if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application.

The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.

Responsiveness

Applications that exceed the 3-year period of performance limit or the direct cost limit of $100,000 per year (including consortium F&A costs) will be considered non-responsive and will not be reviewed. In these cases, CDC/NIOSH will notify the applicant and request that the application be withdrawn.

Indirect costs are limited to 8%. The maximum budget for a 3-year period of performance is $324,000 (including consortium F&A costs). Applications that exceed this limit will be considered non-responsive and will not be reviewed. Applicants will be requested to withdraw non-responsive applications.

Upon receipt, CDC/NIOSH will evaluate all applications for completeness and responsiveness. Incomplete or non-responsive applications will be reviewed. Applicants will be requested to withdraw non-responsive applications.

Note to Applicants

Provide a statement about which NORA sector(s) and cross-sector(s) and which NIOSH strategic and intermediate goals are being addressed. Provide a rationale for how the proposed research will contribute to the specified priority area(s).

Explain how the proposed research will contribute to the NIOSH Research to Practice (r2p) initiative and a statement about their expected Outcomes and Outputs (see Approach).

Include this information in both the Project Abstract and in the Research Strategy (Significance) sections of the application.

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

A button to access the online ASSIST system and links to download application forms are available in Part 1 of this FOA. If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via:

• E-mail: http://grants.nih.gov/support/index.html
• Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

The NIH eRA Service desk is available Monday-Friday, 7 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

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 [email protected] 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

See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

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

Page Limitations

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed. The Research Strategy component of the Research Plan is limited to 12 pages.

Instructions for Application Submission

The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

Other Project Information

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

SF424(R&R) Senior/Key Person Profile Expanded

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

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed. For this FOA, the CDC/NIOSH requires a detailed budget for the initial budget year and a budget for each consecutive year of support.

PHS 398 Cover Page Supplement

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

PHS 398 Career Development Award Supplemental Form

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

• Candidate
• Research Plan
• Other Candidate Information
• Mentor, Co-Mentor, Consultant, Collaborators
• Environment & Institutional Commitment to the Candidate
• Other Research Plan Sections
• Appendix

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

Training in the Responsible Conduct of Research

Applications must include a plan to obtain instruction in the responsible conduct of research. This section should document any prior instruction during the applicant’s current career stage (including the date of last occurrence) and propose plans to receive the necessary instruction. Such plans must address the five required instructional components (format, subject matter, faculty participation, duration of instruction, and frequency of instruction), as outlined and explained in NOT-OD-10-019. The plan may include career stage appropriate, individualized instruction, or independent scholarly activities that will enhance the applicant s understanding of ethical issues related to his or her specific research activities and the societal impact of that research. The role of the sponsor/mentor in responsible conduct of research instruction must be described. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.

Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process.

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

Data Management Plan (DMP):

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.

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

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• Descriptions of the data to be produced in the proposed project;
• How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights);
• Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and
• Plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified.

Examples of DMPs may be found at University of California (https://dmp.cdlib.org/) or USGS (https://www2.usgs.gov/datamanagement/plan/dmplans.php).

CDC Additional Requirement (AR)-25 (https://www.cdc.gov/grants/additionalrequirements/ar-25.html) outlines the components of a DMP and provides additional information for investigators about the requirements for data accessibility, storage, and preservation. The DMP should be developed during the project planning phase, prior to the initiation of collecting or generating public health data, and be submitted with the application.

Applications that do not comply with these instructions may be delayed or not accepted for review. Applications submitted without a required DMP may be deemed ineligible for award unless it is clearly stated why a detailed DMP is deferred to a later date and when it will be provided. In these cases, funding restrictions may be imposed on an award until the DMP is submitted and evaluated.

All instructions in the SF424 (R&R) Application Packages must be followed along with any additional instructions provided in this FOA.

Appendix

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

PHS Human Subjects and Clinical Trials Information

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

The U.S. Department of Health and Human Services and 15 other federal departments and agencies have delayed the effective date and general compliance date of the revised Common Rule until July 19, 2018 (https://www.hhs.gov/ohrp/interim-final-rule-common-rule.html). As implementation decisions are made and further information becomes available, CDC/NIOSH will provide guidance to applicants and awardees.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

Foreign Institutions

For this FOA, applications from foreign institutions are not allowed.

Reference Letters

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC. For more information on expanded authority and pre-award costs, go to: https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.

Awards may be initially issued with restrictions until all information requested can be provided.

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

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

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

CDC requires that mechanisms for, and cost of, public health data sharing be included in grants, cooperative agreements, and contracts. The cost of sharing or archiving public health data may also be included as part of the total budget requested for first-time or continuation awards. Fulfilling the data-sharing requirement must be documented in a Data Management Plan (DMP) that is developed during the project planning phase prior to the initiation of generating or collecting public health data and must be included in the Resource Sharing Plan(s) section of the PHS398 Research Plan Component of the application. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds (for example, privacy and confidentiality considerations, and embargo issues).

Awardees who fail to release public health data in a timely fashion will be subject to procedures normally used to address lack of compliance (for example, reduction in funding, restriction of funds, or award termination) consistent with 45 CFR 74.62 or other authorities as appropriate.

For further information, please see: https://www.cdc.gov/grants/additionalrequirements/ar-25.html for revised AR-25.

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application.

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 (SAM). 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 and compliance with application instructions by the CDC/NIOSH. Applications that are incomplete or non-compliant will not be reviewed.

The sponsoring institution may supplement the CDC/NIOSH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from federal funds unless specifically authorized by the federal program from which such funds are derived. In no case may U.S. Public Health Service (PHS) funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the CDC/NIOSH mission (http://www.cdc.gov/about/organization/mission.htm), all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC/NIOSH peer review system.

Overall Impact

Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Candidate

• Does the candidate have the potential to develop as an independent and productive researcher?
• Is the candidate’s academic, clinical (if relevant), and research record of high quality?
• Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in research?
• Do the letters of reference from at least three well-established scientists address the above review criteria, and do they provide evidence that the candidate has a high potential for becoming an independent investigator?
• Based on the candidate’s prior research and training experience, track record, referee’s evaluations, and the quality and originality of prior research and the current application, what is the candidate’s potential to become a highly successful, independent investigator who will contribute significantly to his/her chosen field of biomedical, behavioral, or clinical related research?
• Does the candidate have the potential to organize, manage, and implement the proposed clinical trial (if applicable), feasibility or ancillary study?

Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring

• What is the likelihood that the plan will contribute substantially to the scientific development of the candidate, leading to scientific independence?
• Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
• Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?

Research Plan

• Are the proposed research question, design, and methodology of significant scientific and technical merit?
• Is the research plan relevant to the candidate’s research career objectives?
• Is the research plan appropriate to the candidate's stage of research development and as a vehicle for developing the research skills described in the career development plan?
• Does the project address the burden, need, and impact (BNI) of the occupational exposures and hazards that are the focus of the proposed research?
• Does the applicant fully justify and provide data to describe the burden of the problem(s) being addressed?
• Is the project likely to have an impact in meeting local, regional, or national occupational safety and health needs through effective research, intervention, translation, outreach, education, or partnership activities?
• Are appropriate impacts identified?

In addition, for applications proposing clinical trials:

The following will apply to candidates who are proposing to gain clinical trial research experience under a mentor s supervision (i.e., applicant will not be leading an independent clinical trial).

• Will the clinical trial experience contribute to the research project and/or the applicant’s research career development?
• For candidates proposing to gain clinical trial research experience (i.e., will not be leading an independent clinical trial), is their role on the clinical trial clearly described.
• Are the scientific rationale and need for a clinical trial, feasibility or ancillary study well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
• Is the clinical trial or ancillary study necessary for testing the safety, efficacy or effectiveness of an intervention, or in the case of a feasibility study necessary to establish feasibility of future clinical trial?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

• Are the qualifications of the mentor(s) in the area of the proposed research appropriate?
• Does the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement?
• Does the mentor adequately describe (1) the quality and extent of his or her proposed role in providing guidance and advice to the candidate and (2) the elements of the research career development activities, including formal course work?
• Is there evidence of the mentor s, consultants, or collaborator s experience in fostering the development of independent investigators?
• Is there evidence of previous research productivity and peer-reviewed support?
• Is active/pending support for the proposed research project appropriate and adequate?
• Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?

In addition, for applications proposing clinical trials:

• If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?
• Does the mentor or mentoring team have the expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet timelines?

Environment & Institutional Commitment to the Candidate

• Is the sponsoring institution clearly committed to ensuring that the candidate will devote the required effort directly to the research described in the application, with the remaining effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?
• Is the institution strongly committed to the career development of the candidate?
• Are the research facilities, resources, and training opportunities adequate and appropriate, including faculty capable of productive collaboration with the candidate?
• Is the environment for the candidate’s scientific and professional development of high quality?
• Is there assurance that the institution intends the candidate to be an integral part of its research program?

In addition, for applications proposing clinical trials:

• Are the administrative, data coordinating, enrollment and/or laboratory/testing centers, appropriate for the trial proposed?
• If applicable, are there plans to add or drop enrollment sites/centers, as needed, appropriate?
• If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in using secure, accurate, and timely methods; and, (4) operate within the proposed organizational structure?
Additional Review Criteria

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

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not allowed.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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 policies regarding dual use research of concern, visit the U.S. Government Science, Safety, Security (S3) website at: Dual Use Research of Concern.

Tools and guidance for assessing DURC potential may be found at: http://www.phe.gov/s3/dual- use/Pages/companion-guide.aspx.

Study Timeline

For applications proposing clinical trials: Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Additional Review Considerations

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

NORA Sectors and Health and Safety Cross-sectors

Does the applicant provide a statement about which NORA sector(s) and cross-sector(s) are being addressed and a rationale for how the proposal will contribute to the specified priority area?

Research to Practice

Reviewers will assess if the applicant has demonstrated about how their proposal addresses the research to practice (r2p) approach (https://www.cdc.gov/niosh/r2p/).

Outcomes and Outputs

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

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

Select Agent Research

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

Resource Sharing Plans

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

Data Management Plan (DMP): The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include: 1) descriptions of the data to be produced in the proposed project; 2) how access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights); 3) use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and 4) plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified.

Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened by CDC/NIOSH , in accordance with CDC peer review and policy procedure, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will undergo a selection process in which all responsive applications will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Relevance of the proposed project to extramural research priority goals identified in the NIOSH Program Portfolio. Funding priority will be given to those applications that clearly address strategic and intermediate goals.
• Availability of funds.
3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf)

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, CDC will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf)

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. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

Expanded Authorities: Any award resulting from an application under this FOA is for research and CDC has automatically waived the prior approvals listed in 45 CFR 75.308(d) (1) through (3). In accordance with HHS regulation and CDC guidance, the awardee will have Expanded Authorities including for post award prior approvals, except for the following three Expanded Authorities: 1) human and animal welfare requirements, 2) acquisition of equipment, and 3) change of principal investigator.

2. Administrative and National Policy Requirements

All HHS CDC grant and cooperative agreement awards include the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) as part of the NoA. For these terms of award, see the HHS Grants Policy Statement and CDC Administrative Requirements (policies) found on the CDC Office of Financial Resources, Grant, webpage.

Recipients of federal financial assistance (FFA) 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. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to CDC grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Review of Risk Posed by Applicants

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

In accordance 41 U.S.C. 2313, CDC is required to review the non-public segment of the

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

CDC’s framework for evaluating the risks posed by an applicant may incorporate results of the evaluation of the applicant's eligibility or the quality of its application. If it is determined that a

Federal award will be made, special conditions that correspond to the degree of risk assessed may be applied to the Federal award. In evaluating risks posed by applicants, CDC will use a risk-based approach and may consider any items such as the following:

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

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

Additional Requirements (ARs)

ARs outline the administrative requirements found in 45 CFR Part 75, the HHS Grants Policy Statement, and other requirements as mandated by statute or CDC policy. Recipients must comply with administrative and national policy requirements as appropriate. For more information on the Code of Federal Regulations, visit the National Archives and Records Administration: http://www.access.gpo.gov/nara/cfr/cfr-table- search.html.

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

Generally applicable ARs are:

AR-1: Human Subjects Requirements

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

AR-3: Animal Subjects Requirements

AR-9: Paperwork Reduction Act Requirements

AR-10: Smoke-Free Workplace Requirements

AR-11: Healthy People 2020

AR-12: Lobbying Restrictions

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

AR-14: Accounting System Requirements

AR-16: Security Clearance Requirement

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

AR-22: Research Integrity

AR-24: Health Insurance Portability and Accountability Act Requirements

AR-25: Release and Sharing of Data

AR-26: National Historic Preservation Act of 1966

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

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

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

AR-31: Research Definition

AR-32: FY 2012 Enacted General Provisions

AR-36: Certificates of Confidentiality

Organization specific ARs are:

AR-8: Public Health System Reporting Requirements

AR-15: Proof of Non-profit Status

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

Additional Policy Requirements
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: HHS Policy on Promoting Efficient Spending.

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

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

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
• CDC Division of Nutrition, Physical Activity and Obesity (https://www.cdc.gov/nccdphp/dnpao/)
• 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 recipient inform their employees in writing (in the predominant native language of the workforce) of employee whistleblower rights and protections under 41 U.S.C. 4712.

Copyright Interests Provision. This provision is intended to ensure that the public has access to the results and accomplishments of public health activities funded by CDC. Pursuant to applicable grant regulations and CDC s Public Access Policy, Recipient agrees to submit into the National Institutes of Health (NIH) Manuscript Submission (NIHMS) system an electronic version of the final, peer-reviewed manuscript of any such work developed under this award upon acceptance for publication, to be made publicly available no later than 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. Recipients (foreign and domestic) receiving CDC funding on or after September 24, 2015 are subject to this policy. Research funded by CDC involving the agents or toxins named in the policy, must be reviewed to determine if it involves one or more of the listed experimental effects and if so, whether it meets the definition of DURC. This review must be completed by an Institutional Review Entity (IRE) identified by the funded institution.

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required by CDC/NIOSH.

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) on all subawards over $25,000. See the HHS Grants Policy Statement for additional information on this reporting requirement.

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

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

Submission of Reports

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

Yearly Non-Competing Grant Progress Report is due 90 to 120 days before the end of the current budget period. The RPPR (https://grants.nih.gov/grants/rppr/index.htm) is to be completed on the eRA Commons website. The progress report will serve as the non-competing continuation application. Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

Annual Federal Financial Report (FFR) SF 425 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 final progress report, invention statement, equipment/inventory report, and final FFR are required 90 days after the end of the project period.

Annual update of intermediate and end outcomes that are the result of the funded research activity are required for a period of 5 years after the period of performance end date.

Content of Reports

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

Description of Progress during Annual Budget Period: Current Budget Period Progress reported on the RPPR form in eRA Commons. Detailed narrative report for the current budget period that directly addresses progress towards the Measures of Effectiveness included in the current budget period proposal.

Research Aims: list each research aim/project

• Research Aim/Project: purpose, status (met, ongoing, and unmet), challenges, successes, and lessons learned.
• Leadership/Partnership: list project collaborations and describe the role of external partners.

Translation of Research (1 page maximum). When relevant to the goals of the research project, the PI should describe how the significant findings may be used to promote, enhance, or advance translation of the research into practice or may be used to inform public 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

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

Additional Reporting Requirements:

Successes: A description of progress on completing activities outlined in the work plan and any additional successes achieved in the past year (identified through evaluation results or lessons learned, for instance).

Challenges: A description of any challenges that might affect the ability to achieve annual and project-period outcomes, conduct performance measures, or complete the activities in the work plan, plus additional challenges encountered in the past year (identified through evaluation results or lessons learned, for instance).

Outputs, Outcomes, and Research to Practice (r2p): Provided 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 immediate products or direct result of project activities, including publications, reports, conference proceedings, presentations/posters, investigator career development activities, databases, tools, methods, guidelines, recommendations, and education and training materials. List the products, tools, guidance, or policy documents developed and whether they are available for use by others; specify when and how they are being shared; and report on methods generated, their implementation, and their success.

Outcomes can be measured over time as either intermediate or end. Intermediate outcomes are specific changes that occur as a result of project activities, such as public or private policy changes; training or workshops based on project outputs; citations in the literature; inventions and patents; and adoption of technologies or methods developed.

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.

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.
The due date for final FFRs will continue to be 90 days after the Period of Performance end date.
Recipients must submit closeout reports in a timely manner. Unless the Grants Management Officer (GMO) of the awarding Institute or Center approves an extension, recipients must submit a final FFR, final progress report, and Final Invention Statement and Certification within 90 days of the end of grant period. Failure to submit timely and accurate final reports may affect future funding to the organization or awards under the direction of the same Project Director/Principal Investigator (PD/PI).
FFR (SF 425) instructions for CDC recipients are now available at NIH Forms Library. For further information, contact [email protected]. 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.

FFR Submission: The submission of FFRs to CDC will require organizations to register with eRA Commons (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: eRA Common Registration & Accounts . Organizations not yet registered can go to Welcome to the Commons for instructions. It generally takes several days to complete this registration process. This registration is independent of Grants.gov and may be done at any time.

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

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.

Specific guidance for the final report and annual outcome update is available on the NIOSH OEP website (https://www.cdc.gov/niosh/oep/grants.html) under Grant Closeout.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

CDC Technical Information Management Section (TIMS)
Telephone: 770-488-2700
Email: [email protected]
Hours: Monday-Friday, 7am - 4:30 pm U.S. Eastern Time

Scientific/Research Contact

Linda West, MSPH
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
Telephone: 404-498-5767
Email: [email protected]

Peer Review Contacts

Price Connor, PhD
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
Telephone: 404-498-2511
Email: [email protected]

Michael Goldcamp, PhD
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
Telephone: 304-285-5951
Email: [email protected]

Financial/Grants Management Contact

Sharon Cassell
Office of the Chief Operating Officer (OCOO)
Centers for Disease Control and Prevention (CDC)
Telephone: 770-488-2703
Email: [email protected]

Section VIII. Other Information
Authority and Regulations

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