Centers for Disease Control and Prevention (CDC)
The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this funding opportunity announcement (FOA) might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.
National Institute for Occupational Safety and Health (NIOSH)
Workers’ Compensation Surveillance
U60 Research Cooperative Agreement
The purpose of this cooperative agreement is to compile, analyze, and disseminate workers’ compensation (WC) data to promote the prevention of occupational injuries, illnesses, fatalities, and exposures to hazards within the states and throughout the nation. The WC Surveillance Cooperative Agreements are intended to provide state health and state WC agencies and other eligible organizations and businesses the resources to initiate or expand state-based WC surveillance and intervention activities.
May 16, 2014
July 29, 2014
August 29, 2014, August 31, 2015, August 29, 2016 by 5:00 PM U.S. Eastern Time.
November-December 2014, November-December 2015, and November-December 2016
March-April, 2015, March-April 2016, and March-April 2017
June 1, 2015
August 30, 2016
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
In 2013, the National Institute for Occupational Safety and Health (NIOSH) established the Center for Workers’ Compensation Studies (CWCS) to integrate NIOSH’s traditional research efforts aimed at preventing worker injury and illness with workers’ compensation (WC) efforts aimed at providing medical care and wage benefits to workers with a work-related injury or illness. In 1970, Congress passed the Occupational Safety and Health Act because “personal injuries and illnesses arising out of work situations impose a substantial burden upon, and are a hindrance to, interstate commerce in terms of lost production, wage loss, medical expenses, and disability compensation payments.” In establishing the CWCS, NIOSH believes that increased efforts need to be made by the public and private sectors to better integrate the injury prevention and injury compensation research and practice communities to the purpose of protecting the health and safety of the American worker and the economic vitality of the Nation (http://www.cdc.gov/niosh/topics/workercomp/cwcs/).
NIOSH has provided technical and financial assistance to states to develop and enhance their occupational safety and health (OSH) surveillance activities. Prior funding opportunity announcements related to NIOSH state-based OSH surveillance include among others the following: State-Based Occupational Safety and Health Surveillance (PAR-09-184) and Program for the Initiation and Development of State-Based Surveillance Capacity in Occupational Safety and Health (OH-02-007). State agencies are in a unique position to generate, access, and use data not gathered by the Bureau of Labor Statistics (BLS). NIOSH-supported analysis of WC data by most states has been limited to the production of one of the state specific Occupational Health Indicators, published by the Council of State and Territorial Epidemiologists (www.cste.org). This includes Indicator 5: Amputations Identified in State Workers’ Compensation Systems, Indicator 8: Carpal Tunnel Syndrome Cases Identified in State Workers’ Compensation Systems, and Indicator 19: Workers’ Compensation Awards (Annual workers’ compensation benefits paid and average amount paid per covered worker).
In addition to sponsoring educational conferences in 2009 and 2012 on the use of WC data for worker safety and health, the NIOSH CWCS is interested in conducting collaborative research with state-based and commercial insurers, state and federal WC administrators, WC organizations such as the National Council on Compensation Insurance (NCCI), self-insured entities, academic investigators, and labor unions. Currently, CWCS researchers are conducting integrated prevention and compensation research across all NIOSH National Occupational Research Agenda (NORA) industry sectors (Agriculture, Forestry and Fishing; Construction, Healthcare and Social Assistance; Manufacturing; Mining; Oil and Gas Extraction; Public Safety; Services; Transportation; Warehousing, and Utilities; Wholesale and Retail Trade).
The CWCS intends to partner with public and private partners to maximize the use of their own WC data to protect workers. States can play a central role in the CWCS to utilize state-specific WC data sources for surveillance and to link surveillance with intervention and prevention activities.
This announcement is intended to encourage and enhance additional or new collaboration between state health and WC agencies to examine WC claims data for all injury and illness outcomes, and builds upon experiences with these previous funding announcements to accomplish objectives of the CWCS.
Healthy People 2020 and other National strategic priorities – NIOSH is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020" http://www.healthypeople.gov/2020/default.aspx. Healthy People 2020 objectives related to occupational safety and health (OSH) are primarily addressed through the National Occupational Research Agenda (NORA). NORA, established by NIOSH and its partners to stimulate research and improve workplace practices, provides a framework to guide OSH research. The goal of the NIOSH research program is to support research that is relevant, of high quality, and that demonstrates impact in reducing occupational disease and injury. Emphasis is placed on research projects that address needs outlined in NORA. NIOSH has created a Program Portfolio to broadly guide activities by categorizing programs into ten (10) major NORA Sector Programs that represent groups of industrial sectors, and twenty-four (24) cross-sector programs organized around adverse health outcomes, statutory programs and global efforts. Detailed information about the Program Portfolio can be found at http://www.cdc.gov/niosh/programs/. Applicants must provide a statement about which industry sector(s) and which cross-sectors are being addressed and a rationale for how the proposal will contribute to the specified priority area (this information must be placed in the Project Description/Abstract).
Public Health Impact - NIOSH expects this FOA to have meaningful impact on the following: 1) OH surveillance and epidemiology and public health research, 2) use and dissemination of findings on the incidence and/or prevalence of occupational injuries, illnesses, and exposures; 3) identification of workers’ compensation related surveillance, trends, costs, emerging issues, high-risk occupations, industries, and worker populations; 4) audience-or professional-specific educational materials and resources for ultimately protecting workers; and 5) development and dissemination of public health recommendations for workplace interventions or protections. These goals foster the integration of occupational public health into broader public health goals and objectives.
Relevant Work - In 2013, NIOSH established the Center for Workers’ Compensation Studies (CWCS) to integrate NIOSH’s traditional research efforts aimed at preventing worker injury and illness with workers’ compensation efforts aimed at providing medical care and wage benefits to workers with a work-connected injury or illness. In 1970, Congress passed the Occupational Safety and Health Act because “personal injuries and illnesses arising out of work situations impose a substantial burden upon, and are a hindrance to, interstate commerce in terms of lost production, wage loss, medical expenses, and disability compensation payments.” In establishing the CWCS, NIOSH believes that increased efforts need to be made by the public and private sectors to better integrate the injury prevention and injury compensation research and practice communities to the purpose of protecting the health and safety of the American worker and the economic vitality of the Nation. In addition to sponsoring educational conferences in 2009 and 2012 on the use of workers’ compensation data for worker safety and health, the NIOSH CWCS is interested in conducting collaborative research with commercial insurers, self-insured entities, academic investigators, state and federal workers’ compensation administrators, and with organizations such as the National Council on Compensation Insurance (NCCI). Currently, CWCS researchers are conducting integrated prevention and compensation research across a wide range of industry sectors. For current research, publications, other resources, program goals, and personnel contact please visit the OWCS website at http://www.cdc.gov/niosh/topics/workerComp/CWCS/.
Objectives/Outcomes - The cooperative agreement will provide states an opportunity to use existing state-level WC data to conduct comparable surveillance including the following: 1) collection, analysis, interpretation, use, and dissemination of findings on the incidence of occupational injuries, illnesses, deaths and exposures to hazards; 2) identification of trends, emerging issues, high-risk occupations, industries, and worker populations; and 3) development of recommendations for workplace interventions.
The objectives are to:
Yearly numbers of medical-only and lost-time WC cases (when applicable), and rates per FTE (incidence, days lost [when applicable]) over a period of years (e.g., at least the last three funded calendar years) based on first reports of injury (FROI) WC data and state employment denominator data:
By NIOSH NORA industry sectors, specific industries (e. g. NAICS 4-digit codes), high-risk occupations, and employer sizes
By injury/illness part of body, nature, and cause
The report should also include the following whenever possible:
Prioritization of NAICS industries and injury/illness cause using metrics including but not limited to basic prevention indices (average of the rank orders of the case count and case incidence) and expanded indices that also average rank orders of case days lost
Time trend analysis and identification of emerging issues
Recommendations for workplace interventions
A comparison of state WC record systems with other state data on occupational injuries and illnesses to estimate combined total numbers and rates
Target population – This FOA addresses workers in states using secondary data solely including U.S. census and other federal and state data. All types of workers, contractors and owners of businesses are reflected in the secondary data for both employment statistics and workers’ compensation claims data.
Collaboration/Partnerships – Anticipated collaboration includes working with administrative and other technical subject experts across workers’ compensation organizations (state WC program, DOH and/or WC insurer) and state surveillance program in the state. A major collaboration effort will be the creation and design of a searchable WC case database. Successful applicants will coordinate with NIOSH to participate in periodic webinars, teleconferences and other meetings to address WC surveillance feasibility and technical topics, and to present state specific findings and highlights.
Evaluation/Performance measurement – Activities and evaluation include, but are not limited to, the following:
Yearly numbers of medical-only and lost-time WC cases, and rates per FTE (incidence, days lost) over a period of years, e.g., at least the last three funded calendar years, based on first reports of injury (FROI) data: By NIOSH NORA industry sectors, specific industries, e. g. NAICS 4-digit codes, high-risk occupations, and employer sizes. By injury/illness part of body, nature, and cause. The report should also include the prioritization of NAICS industries and injury/illness cause using metrics including but not limited to basic prevention indices (average of the rank orders of the case count and case incidence) and expanded indices that also average rank orders of case days lost.
Translation Plan - To maximize the translation of WC surveillance findings, an applicant is strongly urged to utilize trans-disciplinary strategies and approaches and conduct audience-specific translation and dissemination activities. Examples include public health impact and economic burden of work/claims related illnesses and mortality, how and why WC surveillance data informs policy/legislation, advance and inform ‘best practices’ in surveillance and epidemiology, case ascertainment, contribution to workplace solutions (i.e., research to practice) or total worker health protection and promotion e.g., interaction of occupational and personal risk factors for worker health and safety.
Successful applicants must have:
First reports of injury (FROI) developed by the Workers’ Compensation Insurance Organizations (WCIO) and the International Association of Industrial Accident Boards and Commissions (IAIABC)
Reports include populated fields such as injury/illness date, time of day, date employer was notified and date disability began, dates for return to work, coded fields for type of injury and affected body part, descriptive information on the equipment involved, worker activities, work process, sequence of events, and check boxes for use of personal protective equipment.
• Ability to access the following additional state WC data reports: subsequent reports of injury (SROI) - reports include payments for medical and indemnity (partial wage replacement); and Medical Reports - reports include detailed benefit summaries, impairment and disability information
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.
Resubmission e.g., A1
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
NIOSH intends to commit approximately $5.4 million in new money over a period of six years to fund up to 9 states/grantees for three consecutive years (project period) per state.
An applicant state may request up to $200,000 in total costs per 12-month budget period. Although the financial plans of NIOSH provide support for these programs, awards issued under this FOA are contingent upon the availability of funds, programmatic considerations (such as the geographic diversity of awards), and the receipt of meritorious applications as judged by peer review evaluations of the individual components within the application and the application as a whole.
Continuation awards within an approved project period will be made based on satisfactory progress as evidenced by required reports and the availability of funds.
The maximum project period is for three years.
HHS/CDC grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.
Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency’s existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:18.104.22.168.22.214.171.124&idno=48.
Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 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.
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 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 NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the HHS Grants Policy Statement
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIOSH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
As defined in the HHS Grants Policy Statement applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Specific Aims: state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.
Research Strategy: the research strategy should be organized under three headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.
Resource Sharing Plan: 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, with the following modification:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. 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.
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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All HHS/CDC awards are subject to the terms and conditions, cost principles, 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. Funds relating to the conduct of research involving human subjects will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.
Pre-award costs are allowable only as described in the HHS Grants Policy Statement. For more information on expanded authority and pre-award costs, go to http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf and speak to your GMS.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
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 NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and by NIOSH for responsiveness to the RFA. Applications that are incomplete and/or nonresponsive will not be reviewed.
Only the review criteria described below will be considered in the review process. As part of the CDC mission (http://www.cdc.gov/about/organization/mission.htm), all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the project employ novel concepts, approaches, or objectives for WC surveillance, dissemination and other associated activities that lead to enhanced efficiencies or cost-effectiveness?
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Is there evidence of agency/institutional support generally, or specific agency commitment to support WC surveillance and associated activities? Is there documentation of cooperation from relevant local agencies, state agencies, or other participants in the project, where applicable?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
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, as well as the inclusion (or exclusion) of children 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CDC NIOSH, in accordance with NIH 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:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NIOSH Secondary Review Committee. The following will be considered in making funding decisions:
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.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of Award (http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf).
Awardees must comply with the administrative requirements (AR) outlined in 45 Code of Federal Regulations (CFR) Part 74 or Part 92, as appropriate, as well as any additional requirements included in the FOA.
Specific requirements that apply to this FOA are the following:
Generally applicable ARs:
AR-1: Human Subjects Requirements
AR-2: Inclusion of Women and Racial and Ethnic Minorities in Research
AR-9: Paperwork Reduction Act Requirements
AR-10: Smoke-Free Workplace Requirements
AR-11: Healthy People 2010
AR-12: Lobbying Restrictions
AR-13: Prohibition on Use of CDC Funds for Certain Gun Control Activities
AR-14: Accounting System Requirements
AR-16: Security Clearance Requirement
AR-17: Peer and Technical Reviews of Final Reports of Health Studies – ATSDR
AR-21: Small, Minority, And Women-owned Business
AR-22: Research Integrity
AR-24: Health Insurance Portability and Accountability Act Requirements
AR-25: Release and Sharing of Data
AR-26: National Historic Preservation Act of 1966
AR-28: Inclusion of Persons Under the Age of 21 in Research
AR-29: Compliance with EO13513, “Federal Leadership on Reducing Text Messaging while Driving”, October 1, 2009
AR-30: Information Letter 10-006, - Compliance with Section 508 of the Rehabilitation Act of 1973
AR 31 - Distinguishing Public Health Research and Public Health Nonresearch
AR 32 – FY 2012 Enacted General Provisions
Organization Specific ARs:
AR-8: Public Health System Reporting Requirements
AR-15: Proof of Non-profit Status
AR 23: Compliance with 45 C.F.R. Part 87
For more information on the Code of Federal Regulations, visit the National Archives and Records Administration at: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html
To view brief descriptions of relevant CDC requirements visit: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm
3. Additional Policy Requirements
The following are additional policy requirements relevant to this FOA:
HHS Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences and Meetings, Food, Promotional Items and Printing Publications
This policy supports the Executive Order on Promoting Efficient Spending (EO 13589), the Executive Order on Delivering and Efficient, Effective, and Accountable Government (EO 13576) and the Office of Management and Budget Memorandum on Eliminating Excess Conference Spending and Promoting Efficiency in Government (M-35-11). This policy apply to all new obligations and all funds appropriated by Congress. For more information, visit the HHS website at: (http://www.hhs.gov/asfr/ogapa/acquisition/effspendpol_memo.html)
Federal Funding Accountability and Transparency Act of 2006
Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 Web site, www.USASpending.gov (http://www.usaspending.gov/). For the full text of the requirements, please review the following website: http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=109_cong_bills&docid=f:s2590enr.txt.pdf
Plain Writing Act
The Plain Writing Act of 2010 was signed into law on October 13, 2010. The law requires that federal agencies use "clear Government communication that the public can understand and use" and requires the federal government to write all new publications, forms, and publicly distributed documents in a "clear, concise, well-organized" manner. For more information on this law, go to: http://www.plainlanguage.gov/plLaw/index.cfm .
Tobacco and Nutrition Policies
The CDC supports implementing evidence-based programs and policies to reduce tobacco use and secondhand smoke exposure, and to promote healthy nutrition. CDC encourages all awardees to implement the following optional evidence-based tobacco and nutrition policies within their organizations. These policies build on the current federal commitment to reduce exposure to secondhand smoke, which includes The Pro-Children Act, 20 U.S.C. 7181-7184 that prohibits smoking in certain facilities that receive federal funds.
• Healthy food service guidelines that at a minimum align with Health and Human Services and General Services Administration Health and Sustainability Guidelines for Federal Concessions and Vending Operations for cafeterias, snack bars, and vending machines in any facility under the control of the recipient organization and in accordance with contractual obligations for these services. The following are resources for healthy eating and tobacco free workplaces: http://www.gsa.gov/graphics/pbs/Guidelines_for_Federal_Concessions_and_Vending_Operations.pdf; http://www.cdc.gov/nccdphp/dnpao/hwi/toolkits/tobacco/index.htm, and; http://www.cdc.gov/chronicdisease/resources/guidelines/food-service-guidelines.htm
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.
Cooperative Agreement Terms and Conditions of Award
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and CDC grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; CDC Project Officer 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 as a whole, although specific tasks and activities may be shared among the awardees and HHS/CDC as defined below.
The PD(s)/PI(s) will have the primary responsibility for retaining custody of and have primary rights to the data and software developed under the award, subject to Government rights of access consistent with current DHHS, PHS, and CDC policies.
CDC staff will have normal programmatic involvement commensurate with a cooperative agreement award. The NIOSH CWCS staff will be co contacts for scientific and technical matters and questions.
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.
Awardees must also prepare an annual report of the accomplishments and impact of their cooperative agreement, along with lessons learned, appropriate for public release. A final progress report, invention statement, equipment inventory list and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.
Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity depend upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.
Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by recipients: 1) information on executive compensation when not already reported through the Central Contractor Registry; and 2) similar information on all sub-awards/subcontracts/consortiums over $25,000. It is a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable CDC grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf) for additional information on this reporting requirement.
The Recipient Organization must provide HHS/CDC with an original, plus one hard copy of the following reports:
1. Yearly Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHS/CDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm, is due 90 to 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application. Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.
2. Annual Federal Financial Report (FFR) SF 425 is required and must be submitted through eRA Commons within 90 days after the end of each budget period.
3. A final progress report, invention statement, equipment/inventory report , and the expenditure data portion of the Federal Financial Report (FFR) Standard Form (“SF”) 425 Form are required within 90 days of the end of the project period.
4. A concise annual report of the major accomplishments and research impact appropriate for public release.
1. Yearly Non-Competing Grant Progress Report: The grantee’s continuation application/progress report should include:
a) Research Aim/Project: purpose, status (met, ongoing, and unmet), challenges, successes, and lessons learned
b) Leadership/Partnership: list project collaborations and describe the role of external partners.
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 each budget period. The FFR should only include those funds authorized and disbursed during the timeframe covered by the report. The final FFR must indicate the exact balance of unobligated funds and may not reflect any unliquidated obligations. There must be no discrepancies between the final FFR expenditure data and the Payment Management System's (PMS) cash transaction data.
Failure to submit the required information in a timely manner may adversely affect the future funding of this project. If the information cannot be provided by the due date, you are required to submit a letter explaining the reason and date by which the Grants Officer will receive the information. All CDC Financial Expenditure data due on/after October 1, 2012 must be submitted using the FFR via the eFSR/FFR system in the eRA Commons. All Federal Reporting in the Payment Management System is unchanged. All new submissions should be prepared and submitted as FFRs.
CDC’s implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 1/30/2012, the annual FFR is due 6/30/2012 (90 days after the end of the calendar quarter of 3/31/2012). Due dates of final reports will remain unchanged. The due date for final FFRs will continue to be 90 days after the project period end date.
Grantees must submit closeout reports in a timely manner. Unless the Grants Management Officer (GMO) of the awarding Institute or Center approves an extension, grantees must submit a final FFR, final progress report, and Final Invention Statement and Certification within 90 days of the end of grant period. Failure to submit timely and accurate final reports may affect future funding to the organization or awards under the direction of the same Project Director/Principal Investigator (PD/PI).
FFR (SF 425) instructions for CDC grantees are now available at http://grants.nih.gov/grants/forms.htm. For further information, contact GrantsInfo@nih.gov. Additional resources concerning the eFSR/FFR system, including a User Guide and an on-line demonstration, can be found on the eRA Commons Support Page: http://www.cdc.gov/od/pgo/funding/grants/eramain.shtm.
FFR Submission: The submission of FFRs to CDC will require organizations to register with eRA Commons (Commons) (https://commons.era.nih.gov/commons/). CDC recommends that this one time registration process be completed at least 2 weeks prior to the submittal date of a FFR submission.
Organizations may verify their current registration status by running the “List of Commons Registered Organizations” query found at: http://era.nih.gov/commons/. Organizations not yet registered can go to https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp for instructions. It generally takes several days to complete this registration process. This registration is independent of Grants.gov and may be done at any time.
The individual designated as the PI on the application must also be registered in the Commons. The PI must hold a PI account and be affiliated with the applicant organization. This registration must be done by an organizational official or their delegate who is already registered in the Commons. To register PIs in the Commons, refer to the eRA Commons User Guide found at: http://era.nih.gov/commons/index.cfm.
3. Annual Report: A 2-3 page format for major accomplishments and research impacts will be negotiated with the awardee.
4. Final Reports: Final reports should provide sufficient detail for CDC to determine if the stated outcomes for the funded research have been achieved and if the research findings resulted in public health impact based on the investment. The grantee’s final report should include:
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 registration,
submitting and tracking an application, documenting system problems that
threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
CAPT Steve Inserra, MPH
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, NE, MS E-74
Atlanta GA 30333
Nina Turner, PhD
Scientific Review Officer
Office of Extramural Programs/NIOSH
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Road
Morgantown, WV 26505-2845 USA
Grants Management Specialist
Centers for Disease Control & Prevention (CDC)
Procurement and Grants Office (PGO)
Branch 3 Team 2
2960 Brandywine Road, Mail Stop E-01
Atlanta, Georgia 30341
All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Awards are made under the authorization of the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670); Federal Mine Safety and Health Act, Section 501(a), 30 USC 951(a); Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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