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

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/NIOSH support as Public or Private Institutions of Higher Education:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to apply under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. Click here for more information on FFRDCs.

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

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

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) 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.
• o NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

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

Proposed PD(s)/PI(s) must have the appropriate academic credentials and possess experience in conducting public health surveillance in a health department, bona fide agent, tribal nation, or other such organization. It is not required for a PD/PI to have a terminal degree (such as a MD or PhD), nor an exhaustive list of publications to be a successful PD/PI. Candidates are encouraged to provide examples of experience using public health surveillance data and forming and growing collaborations and partnerships to make a difference in public health, such as public health interventions, and changes in policy and behaviors.

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

For institutions/organizations proposing multiple PDs/PIs, NIOSH requires one PD/PI be designated as the "Contact" PI, who will be responsible for all communications between the PDs/PIs and NIOSH, for assembling the application materials outlined below; for leading and managing activities such as scientific, technical, reporting, and research protections which also should be reflected in his/her time commitment in the application. The Contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs. A biographical sketch or other support document is required

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

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

Applicant organizations may only apply for one type of program (Fundamental, Fundamental-Plus, or Expanded). As defined in the HHS Grants Policy Statement, applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit.

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

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

In addition, NIOSH will not accept any application that is essentially the same as one previously reviewed. Resubmission applications may be submitted, according to the Policy on Resubmission Applications from the SF424 (R&R) Application Guide but must include an Introduction addressing the previous peer review critique (Summary Statement).

Applications that exceed the period of performance limit or the total cost per year (including consortium F&A costs) of the proposed Program type (Fundamental, Fundamental-Plus, or Expanded) will be considered nonresponsive and will not be reviewed. In these cases, CDC/NIOSH will notify the applicant and request that the application be withdrawn.

Regarding page limitations, applicants are encouraged to refer to Section IV. Application and Submission Information, Page Limitations, Tables 2 and 3.

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

The SF424 R&R application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA.

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 (PGO TIMS) staff at (770) 488-2700 or [email protected] for further instructions. Hours: Monday-Friday, 7 a.m. to 4:30 p.m. 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.

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

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

The information requested in a letter of intent allows IC staff to estimate the review workload potential and better plan the review.

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

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

The letter of intent should be sent to:

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

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

Table 2. Application Type and Page Limits

Application Type	Page Limit (maximum pages allowed)
Fundamental Program (FP) Application
Program Strategy	New: 14 Renewal: 17
Specific Aims of FP	New & Renewal: 1
Fundamental-Plus Program (FPP) Application
Program Strategy (Includes Program and the 2 Projects)	New: 16 Renewal: 19 (includes Projects)
Specific Aims of FPP (includes Program & Projects)	New & Renewals: 3
Expanded Program (EP) Plan Application
Program Strategy	New: 20 Renewal: 25
Specific Aims of EP (includes Program and Projects)	New & Renewals: 6
Expanded Project Plan (up to 4 each)	New: 15 (for each project) Renewals: 20 (for each project)

Table 3. Section of Application Page Limits

Section of Application	Page Limits (maximum)
Biographical Sketch	5 pages for each Investigator
Appendix	10 pdf files or 100 pages

A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

All instructions in the SF424 (R&R) Application Guide must be followed. Information covered by this form includes Human Subjects Involvement, Project Summary, Project Narrative, Bibliography and Reference Citations, Facilities and Other Resources (Environment), and Equipment.

For Item 12. Other Attachments, follow the instructions in this FOA to upload the following documents ensuring that the files are clearly named:

• Communication and Translation Plan
• Partnerships and Collaboration Plan
• Evaluation and Performance Management Plan
• Project Plans for Fundamental-Plus projects, as appropriate.
• Project Plans for Expanded projects, as appropriate.

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

All instructions in the SF424 (R&R) Application Guide must be followed. Information covered by this form includes Biosketches and Current/Pending Other Support for Project Directors, Principal Investigators, Senior and Key Persons.

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

For the "L. Budget Justification" section:

Fundamental Program applicants will upload one PDF with the budget justification for their fundamental program activities.

Fundamental-Plus Program applicants will upload one PDF with budget justifications for fundamental program activities and each fundamental-plus project. Each budget justification should be clearly separated and labeled (headings may be used).

Expanded Program applicants will upload one PDF with budget justifications for their enhanced fundamental program activities and each expanded project. Each budget justification should be clearly separated and labeled (headings may be used).

Applicants should include funds in their annual budgets for two representatives (including the PI or designee) to attend two NIOSH-convened partner meetings per year, which may be virtual or in person. These one-day meetings will be organized and convened by NIOSH with input from grantees and other partners. One meeting will be held each November-December, usually in conjunction with the CSTE Occupational Health Subcommittee meeting. The other meeting will likely coincide with the CSTE Annual Conference (typically in June) when grantees attend the occupational safety and health sessions at the CSTE Conference. For budget purposes, applicant may assume that the November-December meeting will be held in Washington D.C. and the June meeting in Denver, CO.

In addition, applicants for a FACE program must budget for up to two personnel to attend a two-day annual meeting. Applicants for a pesticide illness related project should also budget for one person to attend an annual one and one-half day meeting. Applicants for a work-related lung/respiratory project are also expected to attend an annual 2.5-day meeting for up to two people. For budget preparation, applicants may assume that these meetings will be in Washington D.C. unless specified otherwise.

Note for budget preparation: An applicant may not propose use of grant funds to host and expend funds for a rented venue for a regional or multi-state scientific meeting or conference without a prior approval from CDC/NIOSH.

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

All instructions in the SF424 (R&R) Application Guide must be followed. This form is optional.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan. Not all components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide for additional information. Please attach applicable sections covered by this form as directed.

Follow the page limits stated in the SF 424 (R&R) unless otherwise specified in this FOA. As applicable to and specified in this FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project.

The varied nature of state surveillance programs, activities, and projects can involve research and non-research activities. Applicants will use the PHS 398 Research Plan Form to provide information on proposed programs, activities, and projects. Applicants are directed to be clear about research and public health practice activities in the descriptions they provide. Applicants may demonstrate commitment by allocating sufficient staff to the proposed work.

1. Introduction to Application (required only for resubmission applications). Summarize substantial additions, deletions, and changes to the application. Respond to the issues and criticism raised in the summary statement. See specific instructions on the content of the introduction on the NIH Resubmission Applications page.

Note: The Research Plan Section is comprised of Specific Aims, Research Strategy, and Progress Report Publication List.

2. Specific Aims (required for all 3 program types). Provide a clear description about the purpose of the proposed programs, projects, and activities and how they address the specific requirements of this FOA. Describe the programs, activities, projects, and research (if applicable); the problems that they will address; and how they will result in OSH impacts and improvements in worker health.

3. Research Strategy. This section will be used to describe the Program Strategy for each program type.

Significance (include BNI and Outputs and Outcomes here)

Innovation

Approach

• Overall approach
• Science
• State Employment Profile
• OHI’s (which ones, why, and how they will be used)
• ABLES

Health Informatics - NNDSS, BRFSS, RCKMS, other (new data sources)

Communication and Translation Plan*

Partnerships and Collaboration Plan*

Underserved Populations (underserved worker groups)

Evaluation and Performance Management Plan*

*these plans can be referenced here and uploaded as clearly named files to Item 12. Other Attachments as noted above.

Where research is involved in these activities, include research strategy that addresses Significance, Innovation, and Approach. If research is not involved, please state that clearly.

Fundamental-Plus applications should follow the outline and guidance above.

For each Fundamental-Plus Project (in-depth follow-back assessment and policy/intervention)

provide a Project Strategy that addresses the specific aims, significance, innovation, and approach. BNI can be included under significance. Senior/key persons should be identified. Biosketches are provided elsewhere. Where research is involved, include your strategy and address significance, innovation, and approach. If research is not involved, please state that clearly.

Fundamental-Plus Project Strategies should be clearly named and uploaded to Item 12. Other Attachments, as noted above.

Expanded Program applications should follow the outline above AND include the enhanced Science, Health Informatics, Communication, Translation, Partnership, and Collaboration activities specified in this FOA.

For each Expanded Program Project (up to 4) provide a Project Strategy that addresses the specific aims, significance, innovation, and approach. BNI can be included under significance. Senior/key persons should be identified. Biosketches are provided elsewhere. Where research is involved, include your strategy and address significance, innovation, and approach. If research is not involved, please state that clearly.

Expanded Program Project Strategies should be clearly named and uploaded to Item 12. Other Attachments, as noted above.

Note: Page limits are identified in this Section (above) under "Page Limitations" in Tables 2 and 3.

4. Progress Report Publication List (for Renewal applications only)

Other Research Plan Section

5. Vertebrate Animals (Not Applicable)

6. Select Agent Research (Not Applicable)

7. Multiple PD/PI Leadership Plan

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources (Not Applicable)

Appendix

12. Appendix

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

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 must address a Data Sharing Plan.

NIOSH considers the sharing of unique data and other research resources developed through the state surveillance occupational safety and health surveillance program an important means to enhance the value and further the advancement of current and future research.

Applicants must include a plan for sharing research resources and data or explain why such sharing is not possible. The precise content of the plan will vary, depending on the data being collected and how the investigator is planning to share the data. Factors to consider include the expected schedule for data sharing, the format of the final dataset, supporting documentation, and whether analytic tools will be provided. Other considerations include whether a data sharing agreement will be required, whether any conditions will be placed on their use, and the mode of data sharing.

Information on data/resource sharing can be found on page II-74 (Sharing Research Tools) of the current HHS Grants Policy.

HHS/CDC policy requires that grant award recipients make unique research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan; Sharing Model Organisms; and Genome Wide Association Studies [GWAS]), as provided in the SF424 (R&R) Application Guide.

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 DMPTool website or USGS.

CDC Additional Requirement (AR)-25 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.

NOTE TO APPLICANTS: This FOA does not allow clinical trials.

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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 revised AR-25.

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. Funds relating to the conduct of human subjects' research will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.

NOTE TO APPLICANTS: THIS IS REQUIRED

CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by considering issues such as financial instability, insufficient management systems, non-compliance with award conditions, the charging of unallowable costs, and inexperience.

The risk assessment will include an evaluation of the applicant s CDC Risk Questionnaire, and a review of the applicant’s history in all available systems; including OMB-designated repositories of government-wide eligibility and financial integrity systems (see 45 CFR 75.205(a)), and other sources of historical information. These systems include, but are not limited to: FAPIIS, including past performance on federal contracts as per Duncan Hunter National Defense Authorization Act of 2009; Do Not Pay list; and System for Award Management (SAM) exclusions.

This questionnaire, along with supporting documentation must be submitted with your application by the closing date of this FOA. Upload the questionnaire and supporting documents as an attachment in the "12. Other Attachments" section of the "R&R Other Project Information" section of the application.

If your organization has completed CDC’s Risk Questionnaire within the past 12 months of the closing date of this FOA, then you must submit a copy of that questionnaire, or submit a letter signed by the authorized organization representative to include the original submission date, organization’s EIN and DUNS. When uploading supporting documentation for the Risk Questionnaire into this application package, clearly label the documents for easy identification of the type of documentation. For example, a copy of Procurement policy submitted in response to the questionnaire may be labeled using the following format: Risk Questionnaire Supporting Documents _ Procurement Policy.

Note: CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920-1132 annually.

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

Report Submission: The applicant must upload the report as an attachment in the "12. Other Attachments" section of the "R&R Other Project Information" section of the application. The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.

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

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

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

Important reminders:

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

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

If the applicant has an FWA number, enter the 8-digit number. Do not enter the letters FWA before the number.

If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of the SF 424 (R&R) Application Guide and in the HHS Grants Policy Statement.

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

https://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm or https://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm.

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.

To expedite review, applicants are requested to notify the CDC/NIOSH Scientific Review Official by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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.

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

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

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

Reviewers will assess and score the following criteria as appropriate for the type of program (or project) being proposed. Reviewers should use the guidance provided as appropriate for assessing the type of application they are reviewing (Fundamental Program, Fundamental-Plus Program, Expanded Program, or Expanded Program Project).

For Fundamental and Fundamental-Plus programs, reviewers will apply the following criteria to the fundamental activities identified in each application. The final impact score for these activities will be assigned to the application.

For each project proposed in a Fundamental-Plus Program application, reviewers will provide comments but will not assign impact scores.

For Expanded Program applications, reviewers will apply the following criteria to the enhanced fundamental activities proposed. The final impact score for these activities will be assigned to the application.

For each project proposed in an Expanded Program application, reviewers will apply the following criteria. The score for each project will be provided in the summary statement.

Significance

Burden

Does the applicant provide enough information on the use of relevant, available, and accessible data for assessing the burden of occupational illnesses, injuries, exposures, or fatalities in their state or region? Does the applicant identify critical industries, underserved worker groups, or other at-risk industry or occupation groups? Are the number of workers exposed or at risk described or discussed? Are the number and types of illnesses, exposures, injuries, or deaths have occurred? Are trends for new or emerging burden described? Does the application address a high burden in a specific geographic region? Does the applicant provide relevant, available, and accessible data about elevated incidence and/or prevalence rates provided for illnesses, injuries, exposures, or fatalities, as compared to national, regional, or other state estimates, if known?

Does the application address a burden in a sector(s) or cross sector(s) that would have a significant economic consequence if that burden is not addressed? Have the most relevant indicators been selected?

Does the application address issues of worker populations for whom occupational safety and health surveillance is limited?

Need

Is there a general statement of need for the occupational safety and health surveillance program and how the proposed work fills a current gap(s) in occupational safety and health surveillance for the state?) Is there evidence that the program proposal will address a knowledge gap? Are important state occupational problem(s) or critical barriers addressed?

Does the application identify the areas where surveillance and linked public health action are needed most? Does the applicant adequately describe how emerging issues or hazards will be anticipated and handled? Is the proposed methodology (such as data analyses, interventions, and translation) well-defined and appropriate to the type of program proposed? Is the proposed work feasible? Is this the best time for undertaking this program? Does this proposal address an explicit stakeholder need?

Impact

Does the application describe the potential to reduce burden and be successful in generating knowledge or products that will be used by stakeholders? Are intermediate outcomes described that might result in reduced burden or improved health and well-being in the near- or long-term? Is it clear who will benefit from the proposed program (or project)? Are appropriate partners or stakeholders involved for the successful transfer of the findings to the end users or intended audience? Are appropriate impacts identified?

If successful, will the program have the potential to be used in setting standards, guidance, policy, or recommendations? Is there discussion of how the proposed outcomes could be adopted by manufacturers, trade associations, or others? Is there the 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 program (or project)? Is there a potential for technology to be transferred into the marketplace? Is there the potential for program (or project) activities to be scalable or adaptable to reach "at-risk" worker population(s)?

Is there potential for partners to assist in tracking progress of translation efforts? Have relevant partnerships needed to set the stage for impact been described and documented?

Is there potential for this program to be influential in that it will lead others to investigate the problem, open new areas or topics of surveillance research, or improve the scientific approach or public health practice?

Investigator(s)

Do the PDs/PIs have the skills, knowledge, and resources necessary to carry out the proposed program or project activities? Do the proposed PD(s)/PI(s) have the appropriate academic credentials and possess experience in conducting public health surveillance in a health department, bona fide agent, tribal nation, or other such organization? It is not required for a PD/PI to have a terminal degree (such as a MD or PhD), nor an extensive list of publications to be a successful PD/PI. However, if research is proposed, does the PD/PI have the appropriate experience and expertise in proposed methodologies or populations described in the approach?

Does the application contain examples of how the PD(s)/PI(s) have used public health surveillance data and developed and grew collaborations and partnerships to make a difference in public health, such as public health interventions; public health communications (including dissemination, outreach, and training); and changes in policy and behaviors? Does the application contain biographical sketches or other support documents for each of the PD(s)/PI(s)? Is a Contact PD/PI designated for the Program and Projects proposed, if more than one PD/PI is proposed?

If multiple PDs and PIs are proposed, do the key personnel investigators have complementary and integrated expertise and does the program have appropriate leadership approach, governance, and organizational structure? Does the application identify how each of the PD(s)/PI(s) will be responsible for leading and managing activities such as scientific, technical, reporting, and research protections (if appropriate)? Does application reflect how the time commitment will be allocated for each PD(s)/PI(s) per the program?

Innovation

Will the applicant test or use new tools or methods to acquire, review, and evaluate occupational safety and health data in order to better understand the incidence, prevalence, and prevention of occupational injuries, illnesses, exposures, or deaths?

Is a refinement, improvement, or new applications of concept or approaches proposed? Does the proposal challenge and seek to shift current occupational safety and health, public health practice, or workplace practice paradigms by using new concepts, approaches, instrumental, or interventions? Does the program (or project) address a recognized critical barrier to progress in the field or take unique or significant advantage of the results from a recent project?

Do specific project activities utilize new or improved methodologies, address novel populations, and/or implement novel approaches to information dissemination?

Are new strategies proposed for programs (or projects) that minimize the time for data acquisition, release of data, data incompatibility, or technologies or systems for interface with programs-specific data? Are there opportunities for collecting new data or incentive for collaboration with external data stewards?

Approach

Are the strategy, methodology, and analyses well-reasoned and appropriate for accomplishing the specific aims of the program? Are potential problems, alternative strategies, and benchmarks for success presented? If the program or project is in the early stages of development, will the strategy establish feasibility, and will risky aspects be managed? Does the applicant describe how they plan to access data for surveillance from identified data sources or collaborations? If data linkages are required, as described in the application, does the applicant describe how they will accomplish the linkages? If critical barriers to accessing data for surveillance are identified, has the applicant adequately described how the barriers will be addressed?

If the aims of the program and project are achieved, how will surveillance be improved? How will successful completion of the aims possibly enhance concepts, methods, technologies, interventions or policies that drive this field? Does the applicant propose using evidence-based interventions or strategies in the program or project? Are outcomes and outputs identified and are measures/metrics that will be used to assess outcomes included? Does the application describe how the results from surveillance findings will be disseminated and ultimately used? Is there an evaluation plan and is it adequate?

Does the applicant describe how proposed collaborations across agencies, agency departments, universities, and other organizations will improve worker safety and health by preventing illnesses, injuries, exposures, and fatalities? Does the applicant describe how they will partner with other public health programs or other state agencies to integrate occupational safety and health into their programmatic activity? Are partnerships with other NIOSH-funded entities (Agriculture Centers, Total Worker Health Centers, Education and Research Centers, or Training Project Grants in the state or the region? Are appropriate partners identified and are their roles well defined?

Does the applicant adequately describe how surveillance findings will be communicated and disseminated to stakeholders? Does the applicant adequately describe the use of electronic means of communication, social media, or other contemporary means of communicating (if available to the applicant) to reach workers, employers, public health and other stakeholders in the state?

Does the applicant describe the composition of the advisory committee and how the group will function to give input on issues and priorities? Does the applicant adequately describe how the membership can change to reflect emerging issues and priorities, such that members may rotate on and off as needed by the applicant in order to best utilize the expertise and guidance of the members?

If the program activities involve human subjects, is there an appropriate plan for protection of human subjects from research risks and is any plan for inclusion of minorities, members of both sexes/genders, or children justified in terms of the program or project goals and strategy proposed?

Human Subjects Research and IRB Determinations: Does the applicant describe how their institution makes the determination of whether which activities within their program or project meets or does not meet the definition of human subjects' research? An overview of their process and who or what body/group makes those decisions, if multiple steps are involved, must be described. It is the applicant's responsibility to ensure their process is adequately defined and justified; if it isn't, it could adversely affect an applicant's score.

Environment

Will the program (or project) work environment and organizational capacity, such as staff, institutional support, equipment, and other physical resources available to the PD(s)/PI(s), contribute to the probability of success of the program (or project) proposed? Are these resources adequate and will they benefit the program (or project) proposed? Has the applicant described goals for developing program (or project) capacity over the five-year funding period?

Does the applicant provide evidence of their capacity to conduct routine descriptive analyses of data to evaluate its quality and completeness, and identify and prioritize surveillance issues in their jurisdiction? Does the applicant provide evidence of surveillance capacity to respond to requests for technical assistance from other programs and decision makers? Does the applicant provide evidence of using public health surveillance data for prevention efforts?

Will the program (or project) benefit from unique features of the scientific environment, public health approach, or subject population?

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.

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

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

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

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

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

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

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

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 clear.

Dual Use Research of Concern

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

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

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.

Outcomes and Outputs

Reviewers will assess whether the applicant has provided enough information about the expected outcomes and outputs of the proposal and how the Program will impact the field of occupational safety and health.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

NIOSH considers the sharing of unique data and other research resources developed through the State Occupational Safety and Health Surveillance Program an important means to enhance the value and further the advancement of current and future research.

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

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).

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

Investigators responding to this announcement should include a detailed DMP in the Resource Sharing Plan(s) section of the PHS 398 Research Plan Component of the application. The AR-25 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

The DMP should be developed during the project planning phase prior to the initiation of collecting or generating public health data and will be submitted with the application. The submitted DMP will be evaluated for completeness and quality at the time of submission.

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

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

As part of the scientific peer review, all applications:

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

Following initial peer review, a NIOSH Secondary Review Committee will provide a second level of review for programmatic relevance and balance.

The following will be considered in making funding decisions about the proposed occupational safety and health surveillance programs:

• Scientific and technical merit as determined by peer review.
• Relevance to NIOSH priorities and needs.
• Potential contribution to a blend or balance of Fundamental, Fundamental-Plus, and Expanded programs that advance understanding of the incidence, prevalence, and prevention of occupational injuries, illnesses, exposures, and deaths in the US.
• Potential for meaningful impact on OSH by developing workplace interventions, guidelines for eliminating or reducing worker exposures and hazards, and improving worker health and safety.
• Results (outputs and outcomes) of prior surveillance awards funded by CDC/NIOSH.
• Commitment of the applicant institution and PI to collaborative efforts.
• Geographic balance of OSH surveillance programs among regions of the country.
• Adequacy of data/resource sharing plan.
• Administrative/managerial capability of the applicant institution.
• Availability of funds.

The NIOSH Secondary Review Committee will consider applications for funding based on the program type and the projects proposed.

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications.

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.

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

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

Awardees must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be 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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in CDC-funded studies, the awardee must provide CDC copies of documents related to all major changes in the status of ongoing protocols. For multi-site research, please see NIH Single IRB Policy.

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.

All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement and CDC Administrative Requirements (policies) found on the CDC Office of Financial Resources, Grant, webpage.

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. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please visit here and here for more information. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws here 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 here.

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 Part 75 or the reports and findings of any other available audits; and
• The applicant's ability to effectively implement statutory, regulatory, or other requirements imposed on non-Federal entities.

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

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

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

Generally applicable ARs are:

AR-1: Human Subjects Requirements

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

AR-3: Animal Subjects Requirements

AR-9: Paperwork Reduction Act Requirements

AR-10: Smoke-Free Workplace Requirements

AR-11: Healthy People 2020

AR-12: Lobbying Restrictions

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

AR-14: Accounting System Requirements

AR-16: Security Clearance Requirement

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

AR-22: Research Integrity

AR-24: Health Insurance Portability and Accountability Act Requirements

AR-25: Data Management and Access

AR-26: National Historic Preservation Act of 1966

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

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

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

AR-31: Research Definition

AR-32: Appropriations Act, General Provisions

AR-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 CFR Part 87

The following are additional policy requirements relevant to this FOA.

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

This policy supports the Executive Order on Promoting Efficient Spending (EO 13589), the Executive Order on Delivering and Efficient, Effective, and Accountable Government (EO 13576) and the Office of Management and Budget Memorandum on Eliminating Excess Conference Spending and Promoting Efficiency in Government (M-35-11). This policy applies to all new obligations and all funds appropriated by Congress. For more information, visit the HHS website 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, http://www.usaspending.gov/. For the full text of the requirements, please review the following website: https://www.fsrs.gov/.

Plain Writing Act

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

Tobacco and Nutrition Policies

The CDC supports implementing evidence-based programs and policies to reduce tobacco use and secondhand smoke exposure, and to promote healthy nutrition. CDC encourages all 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:

https://www.gsa.gov/cdnstatic/Guidelines_for_Federal_Concessions_and_Vending_Operations.pdf

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

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

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

Pilot Program for Enhancement of Employee Whistleblower Protections

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

Copyright Interests Provision

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

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

Language Access for Persons with Limited English Proficiency

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

Dual Use Research of Concern

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

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

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

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

Federal Information Security Management Act

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when state and local governments are eligible to apply), and other HHS, PHS, and CDC rant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an assistance mechanism (rather than an acquisition mechanism), in which substantial CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients activities by involvement and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project, although specific tasks and activities may be shared among the awardees and HHS/CDC as defined below.

The PDs/PIs will have primary responsibility for the following:

• Designing and conducting OSH surveillance program activities to address the described objectives of this cooperative agreement.
• Partnering effectively with outside entities expected to participate in the proposed surveillance program activities, and research if applicable. Such partnerships should be well-defined and documented by letters of support or memoranda of understanding which detail the nature and extent of the collaboration.
• Establishing goals and objectives that are realistic, measurable, and time-oriented for all phases of the project.
• Collaborating with CDC/NIOSH in design and implementation of surveillance activities and the analysis, interpretation, and dissemination of study findings.
• Developing, designing, and piloting research protocols and instruments; recruiting participants according to the defined sampling strategy; and conducting appropriate data management procedures, if applicable.
• Analyzing data and disseminating findings in peer-reviewed journals, state reports, and presentations at scientific conferences and other meetings.
• Attending and participating in monthly and/or quarterly NIOSH grantee calls and bi-annual grantee research meetings.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to government rights of access consistent with current HHS, PHS, and CDC policies.

NIOSH staff with relevant subject matter expertise may have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. These include, but are not limited to, these activities:

• Assisting in review of research protocols (such as for sampling, recruitment, assessment, and data management).
• Advising on or participating in analysis, interpretation, and dissemination of study findings.
• Attending and participating in monthly and/or quarterly NIOSH grantee calls and bi-annual grantee meetings.
• Monitoring and evaluating the scientific and operational accomplishments of the project through conference calls, site visits, grantee meetings, and review of technical reports.

Specific substantial involvement activities for NIOSH project scientists will be negotiated further with each grantee as part of the pre-award process. This will include adding special terms and conditions in the NOA.

NIOSH Program Official (PO)

Additionally, the Scientific/Research Contact named in this announcement will serve as the Program Official (PO) for all awards. This person will be responsible for the normal scientific and programmatic stewardship of these awards and will be named in the NOAs. The PO will have programmatic involvement during the conduct of this activity through approval of progress reports, human subjects' protection, and advice and coordination commensurate with normal program stewardship for grants. Other PO responsibilities include these:

• Ensuring that all requirements are met prior to issuance of an initial award.
• Conducting objective and independent evaluation of progress toward specific aims or objectives.
• Approving noncompetitive continuation of the award.
• Recommending corrective actions as needed.
• Carrying out administrative and technical duties such as giving grant cycle or funding information, programmatic approvals and recommendations, consultation or technical assistance pertaining to administration requirements of the award; monitoring performance of the recipient; processing "just in time" information for research projects; approving final reports before release and distribution; communicating guidance and policy; facilitating budget recommendations; visiting programs/sites; attending grantee meetings; and disseminating grantee information and reports.
• Providing guidance or information that addresses recipient inquiries.
• Participate in and facilitate development of goals and agenda for grantee meetings, as necessary

Areas of Joint Responsibility

Responsibilities are divided between awardees and NIOSH staff as described above. Substantial involvement responsibilities of NIOSH project scientists will be collaborative, consultative, and facilitative, not proscriptive, in nature.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and NIOSH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened and will have three members: a designee of the awardee, a NIOSH designee, and a designee with expertise in the relevant area who is chosen by the other two. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D, and HHS regulations 45 CFR Part 16.

Grantee Meetings

Recipients are expected to attend and include funds in their annual budgets for two representatives, including the PI or designee, to attend two NIOSH-convened grantee (Partner) meetings per year (may be in person or virtual). These one-day meetings will be organized and convened by NIOSH officials with input from the grantees and others. One of these meetings will be held each November-December, usually in conjunction with the CSTE Occupational Health Subcommittee meeting. Another meeting will possibly coincide with the CSTE Annual Conference (typically in June) during which grantees attend the OSH sessions at the CSTE Conference. For budget preparation for all years of requested support, assume the November-December meeting will be held in Washington D.C. and the June meeting in Denver, CO unless notified otherwise.

In addition to the meetings described above, applicants for the FACE program must budget for up to two personnel to attend a two-day annual meeting. Applicants for the pesticide illness related project should budget for one person to attend an annual one and one-half day meeting. Applicants for the work-related lung/respiratory project are expected to attend an annual two-and one-half day meeting for up to two people. For budget preparation, assume these meetings will be held in Washington D.C. unless specified otherwise.

Note for budget preparation: An applicant may not propose use of grant funds to host and expend funds for a rented venue for a regional or multi-state scientific meeting or conference without a prior approval from CDC NIOSH.

CDC Grantee SAS Statistic Software Licenses

Note for budget preparation: An applicant may also request a reduced-cost CDC grantee SAS statistical software license. However, only one SAS PC-compatible base-type license per program and Expanded Project may be requested, subject to CDC availability and policy and based on availability of funds. If the license(s) application is approved by CDC, NIOSH will reduce (offset) the annual award amount by the cost of the SAS license(s). Allow 1-2 months for CDC processing of a state request, immediately after award, in coordination with the CDC SAS support program. Reduction of Award funds may vary by year over the grant 5-year project period due to possible fluctuation in annual SAS license cost.

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

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

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 awardees: 1) information on executive compensation when not already reported through the SAM Registration; and 2) similar information on all sub-awards/ subcontracts/ consortiums over $25,000. All 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.

Annual Report of Major Outputs, Accomplishments and Outcomes. The report will be written in a style and semi technical content for uptake by professionals. A 5-page PDF-type page limit each will apply for all three types of Programs and for each Expanded Projects and should include a page for outcomes and outputs such as publications, citations, and other product descriptions. An additional 2 pages will be allowed for two success stories (one page maximum each) that can be utilized by NIOSH or CSTE. NIOSH will select 6-8 success stories to feature for their yearly NIOSH/Office of Extramural Programs Annual Report, or to feature throughout the year in their eNews or Research Rounds features. The PD/PI is fully responsible for its content, and NIOSH does not intend to substantially edit the submission. including a page for publications, citations and other product descriptions. The author is fully responsible for its content, and NIOSH does not intend to substantially proof or edit the submission. NIOSH may post the report on its website for public viewing. This report will be due typically in mid-August each year.

Evaluation and Performance Management should be discussed along with evaluation results.

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

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

2. Annual Federal Financial Report (FFR) SF 425 is required and must be submitted through eRA Commons within 90 days after the end of the calendar quarter in which the budget period ends.

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

1. Yearly Non-Competing Grant Progress Report

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

• Description of Progress during Annual Budget Period: Current Budget Period Progress reported on the 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 scientific findings be translated into public health practice or inform public health policy?

How will the project improve or effect the translation of research findings into public health practice or inform policy?

How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in public health programs or practices?

How will the findings advance or guide future research efforts or related activities?

• Public Health Relevance and Impact (1 page maximum). This section should address improvements in public health as measured by documented or anticipated outcomes from the project. The PI should consider how the findings of the project relate beyond the immediate study to improved practices, prevention or intervention techniques, inform policy, or use of technology in public health. Questions to consider in preparing this section include:

How will this project lead to improvements in public health?

How will the findings, results, or recommendations been used to influence practices, procedures, methodologies, etc.?

How will the findings, results, or recommendations contribute to documented or projected reductions in morbidity, mortality, injury, disability, or disease?

• Current Budget Period Financial Progress: Status of obligation of current budget period funds and an estimate of unobligated funds projected provided on an estimated FFR.
• New Budget Period Proposal: Detailed operational plan for continuing activities in the upcoming budget period, including updated Measures of Effectiveness for evaluating progress during the upcoming budget period. Report listed by Research Aim/Project.
• Project Timeline: Include planned milestones for the upcoming year (be specific and provide deadlines).
• New Budget Period Budget: Detailed line-item budget and budget justification for the new budget period. Use the CDC budget guideline format.
• Publications/Presentations: Include publications/presentations resulting from this CDC grant only during this budget period. If no publication or presentations have been made at this stage in the project, simply indicate Not applicable: No publications or presentations have been made."
• IRB Approval Certification: Include all current IRB approvals to avoid a funding restriction on your award. If the research does not involve human subjects, then please state so. Please provide a copy of the most recent local IRB and CDC IRB, if applicable. If any approval is still pending at time of APR due date, indicate the status in your narrative.
• Update of Data Management Plan: The DMP is considered a living document that will require updates throughout the lifecycle of the project. Investigators should include any updates to the project’s data collection such as changes to initial data collection plan, challenges with data collection, and recent data collected. Applicants should update their DMP to reflect progress or issues with planned data collection and submit as required for each reporting period.

2. Annual Federal Financial Reporting

The Annual Federal Financial Report (FFR) SF 425 is required and must be submitted through 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.

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

FFR (SF 425) instructions for CDC grantees are now available at 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 an 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.

3. Final Reports

Final reports should provide enough 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 under Grant Closeout.

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

CAPT Linda West, MSPH, USPHS
Scientific Program Official
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention (CDC)
Telephone: 404-498-5767
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Questions regarding peer review may sent to:

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

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

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

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.