Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

Centers for Disease Control and Prevention (CDC)

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

Components of Participating Organizations

National Institute for Occupational Safety and Health (NIOSH)

Funding Opportunity Title

Agricultural, Forestry and Fishing Safety and Health Research (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices
  • September 17, 2014 - See Notice NOT-OH-14-016. Resubmission Applications Allowed for PAR-14-175 "Agricultural, Forestry and Fishing Safety and Health Research (U01)"
Funding Opportunity Announcement (FOA) Number

PAR-14-175

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.262

Funding Opportunity Purpose

NIOSH is soliciting applications to conduct agricultural injury and disease research. While emphasis will be placed on proposals in the areas of forestry/logging, vulnerable populations and research to practice efforts, any application associated with occupational safety and health concerns in this work sector will be accepted. 

Key Dates
Posted Date

April 10, 2014

Open Date (Earliest Submission Date)

May 9, 2014

Letter of Intent Due Date(s)

May 5, 2014; September 26, 2014

Application Due Date(s)

June 9, 2014; October 31, 2014, by 5:00 PM Eastern Standard Time (EST).

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2014; January 2015

Advisory Council Review

August 2014; April 2015

Earliest Start Date

September 2014; September 2015

Expiration Date

November 3, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA.  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.


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Statutory Authority

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. Awards are made under the authorization of the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670); Federal Mine Safety and Health Act, Section 501(a), 30 USC 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

1. Background and Purpose

Agriculture, forestry and fishing continue to rank among the most hazardous industries in the US. (National Census of Fatal Occupational Injuries) Data for 2005-2009, indicate that overall fatality rates for workers in agriculture (farming, ranching, forestry, logging and fishing) continue to be at least 6-10 times greater than U.S. workers in general. Fatality rates for parts of these industries (commercial fishing, logging) are often much higher than U.S. workers in general. Overall fatality rates in agriculture typically exceed those for occupations traditionally known as dangerous, such as mining and construction.

Farmers and agricultural workers are also at high risk for nonfatal injuries, work-related lung diseases, noise-induced hearing loss, skin diseases, and certain cancers associated with chemical use and prolonged sun exposure. Farming is one of the few industries in which families (who often share the work and live on the premises) are also at risk for injuries, illness, and death.

Logging in particular has consistently been one of the most hazardous industries in the US. In 2008, the logging industry employed 86,000 workers, and accounted for 93 deaths which resulted in a fatality rate of 108.1 deaths per 100,000 workers. This rate is over 30 times higher than the overall fatality rate in the US in 2008 (3.5 deaths per 100,000). This excessive risk for fatal work injuries points to a need for prioritizing surveillance, research and intervention programs to make this industry less hazardous.

Vulnerable workers, intervention research, dissemination, and communication continue to be programmatic priorities for the NIOSH Agriculture, Forestry, and Fishing (AgFF) Program. Two recent program reviews have recommended that NIOSH continue to work to enhance understanding of unique factors affecting populations at risk, as well as dissemination, diffusion, and scaling up of interventions for all workers in the Sector. Specific recommendations can be viewed at http://www.cdc.gov/niosh/programs/agff/naseval.html and http://www.cdc.gov/niosh/programs/agff/independent.html.

NIOSH has initiated a Research to Practice (r2p) initiative to reduce or eliminate occupational illness and injury by increasing the transfer and translation of knowledge, interventions, and technologies into highly effective prevention practices and products into the workplace. R2p is an interactive process in which the occupational safety and health community – including researchers, communicators, decision-makers, and employer/employee groups – work collaboratively to

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 NORA strategic plan, including information about the goals relevant to this funding opportunity announcement, for the AgFF Sector can be accessed at http://www.cdc.gov/niosh/nora/comment/agendas/AgForFish/pdfs/AgForFishDec2008.pdf. 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/ and specific information on the Agriculture, Forestry and Fishing Program Portfolio can be found at  http://www.cdc.gov/niosh/programs/agff/.

Applicants must provide a statement about 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 – Research and intervention activities are needed to reduce the tremendous burden and cost associated with occupational injuries and illnesses occurring in the American agriculture sector.

2. Approach

The purpose of this cooperative agreement program is to further our understanding of the risks and conditions associated with forestry or logging related occupational diseases and injuries, to explore methods for reducing risks and for preventing or minimizing exposure to hazardous conditions in the these work environments, and to translate significant scientific findings into prevention practices and products that will effectively reduce work-related illnesses and injuries in this area.  In addition, this cooperative agreement aims to enhance our knowledge about the effectiveness of existing interventions and the best ways to disseminate, diffuse, and translate proven interventions to benefit workers in the AgFF sector, in particular our ability to address the unique needs of vulnerable workers.

As defined in the NORA AgFF Strategic Plan, vulnerable workers are those who experience disproportionate rates of occupational injuries and illnesses within the AgFF Sector because of social or physiological factors which can lead to increased workplace exposures and/or individual susceptibilities. For many workers, vulnerability is multi-factorial and may change during the worker’s career. Appropriate interventions require an understanding of the factors that alter the vulnerability of workers in the AgFF Sector. Examples of AgFF Sector worker populations that may be considered vulnerable because of these social and physiologic factors include: recent immigrants and Latino workers, younger workers, older workers, physically- or cognitively-disabled workers, and unpaid family workers.

Proposals should address research objectives supported by NIOSH, which include, but are not limited to the following:

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

The causes of work-related injuries and illnesses are complex, and determining the effect that specific research activities have on them can take years. Thus, outcomes can be measured over time as either intermediate or end. Intermediate outcomes are specific changes that occur as a result of research activities. Examples of intermediate outcomes include public or private policy changes, conduct of training or workshops based on project outputs, citations in the literature, inventions and patents, and adoption of technologies or methods developed by the researcher. End outcomes are the ultimate goal of the research and the result of what individuals or institutions do with the knowledge or products generated by the research. Examples of end outcomes include reduction in workplace illnesses, injuries, fatalities, and/or hazardous exposures. Applicants must provide a brief statement about expected outputs and outcomes of their proposed research in the Description (Abstract) and in the Research Strategy (Significance).

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Other: A mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications

Application Types Allowed

New

Revision

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

Funds Available and Anticipated Number of Awards

NIOSH intends to commit $1.2M in FY 2014 to fund 4-6 awards.

Award Budget

Maximum amount (total costs) available per award is $275,000 per year for three years.

Award Project Period

Three years

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html), are not allowed.

Required Registrations

Applicant Organizations

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

Eligible Individuals (Program Director/Principal Investigator)

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

2. Cost Sharing

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html).

3. Additional Information on Eligibility

Number of Applications

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

 As defined in the HHS Grants Policy Statement,

 (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html), 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.  

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at:  TTY 1-888-232-6348

2. Content and Form of Application Submission

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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and 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:

The letter of intent should be sent to:

Steve Dearwent, PhD
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
Telephone: (404) 498-6382
Email: sed7@cdc.gov  

Overnight address:
2400 Century Parkway NE (4th floor)
Atlanta, GA 30345-3114

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

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.

Instructions for Application Submission
PHS 398 Research Plan

The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components.  Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs).  Specifically, some of the following 16 components are for Resubmissions or Revisions only.  See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000) for additional information.  Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description). Follow the page limits stated in the SF 424 unless otherwise specified in the FOA.  As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

Human Subjects Section

Other Research Plan Sections

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

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf)

must be followed along with any additional instructions provided in the FOA.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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 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 responsiveness by NIOSH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the CDC 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.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

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 approach, governance and organizational structure appropriate for the project?   

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

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?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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, 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.

Vertebrate Animals

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.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

 r2p

Does the applicant provide information about how their proposal addresses r2p?

Outcomes and Outputs

Does the applicant provide information about the expected outcomes and outputs and how this research will impact the field of agricultural health and safety?

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: http://www.cdc.gov/od/foia/policies/sharing.htm. Investigators responding to this funding opportunity should include a plan on sharing research resources and data.

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/od/pgo/funding/budgetguide.htm.   

Applications from Foreign Organizations

Not Applicable

2. Review and Selection Process

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

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. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Section VI. Award Administration Information

1. Award Notices

Any applications awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements.  If the application is under consideration for funding, HHS/CDC will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html).

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 allowable as an expanded authority, but only if authorized by CDC.

2. Administrative and National Policy Requirements

Cooperative Agreement Terms and Conditions of Award

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-3: Animal Subjects Requirements

AR-7: Executive Order 12372 Review

AR-9: Paperwork Reduction Act Requirements

AR-10: Smoke-Free Workplace Requirements

AR-11: Healthy People 2010

AR-12: Lobbying Restrictions

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

AR-14: Accounting System Requirements

AR-16: Security Clearance Requirement

AR-21: Small, Minority, And Women-owned Business

AR-22: Research Integrity

AR-24: Health Insurance Portability and Accountability Act Requirements

AR-25: Release and Sharing of Data

AR-26: National Historic Preservation Act of 1966

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

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

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

AR 31 - Distinguishing Public Health Research and Public Health Nonresearch

AR 32 – FY 2012 Enacted General Provisions   

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

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.

Tobacco:

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:

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

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 Officers are not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the 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 Recipient will have the primary responsibility for management, administrative and scientific aspects of the work including data, resources and operations.  Other primary responsibilities may include:

The NIOSH Office of Extramural Programs and the CDC Procurement and Grants Office will designate a Program Official (PO) for this cooperative agreement. This person will be responsible for the normal programmatic stewardship of the award and will be named in the NoA. The PO will have programmatic involvement during the conduct of this activity through approval of progress reports, human subjects protection, annual summary reports, and providing advice and coordination commensurate with normal program stewardship for grants. The responsibilities of the PO include:

NIOSH anticipates having substantial scientific involvement during conduct of this activity in the form of technical assistance, collaboration, guidance and coordination. One or more NIOSH Project Scientists may be involved. Responsibilities of the NIOSH Project Scientist(s) may include:

All programmatic contact associated with the science and/or technical implementation of the research will include the Program Official to ensure that the cooperative agreement partner(s) have a clearly defined line of communication with the institute.  The Program Official will be the primary conduit for all intramural interactions.

3. Reporting

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.

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. 

Submission of Reports

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

Yearly Non-Competing Grant Progress Report, (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.

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.

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.

Content of Reports

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

Description of Progress during Annual Budget Period: Current Budget Period Progress reported on the PHS 2590 (http://grants.nih.gov/grants/funding/2590/2590.htm)  http://grants.nih.gov/grants/funding/2590/2590.htm: Detailed narrative report for the current budget period that directly addresses progress towards the Measures of Effectiveness included in the current budget period proposal.

Research Aims: list each research aim/project

Research Aim/Project: purpose, status (met, ongoing, and unmet), challenges, successes, and lessons learned

Leadership/Partnership: list project collaborations and describe the role of external partners.

Translation of Research (1 page maximum). When relevant to the goals of the research project, the PI should describe how the significant findings may be used to promote, enhance, or advance translation of the research to policy or practice. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. The PI should identify the research findings that were translated into public health policy or practice and how the findings have been or may be adopted in public health settings. Or, if they cannot be applied yet, this section should address which research findings may be translated, how these findings can guide future research or related activities, and recommendations for translation. If relevant, describe how the results of this project could be generalized to populations and communities outside of the study. Questions to consider in preparing this section include:

How will the scientific findings be translated into public health policy or practice?

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

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, policy, or use of technology in public health. Questions to consider in preparing this section include:

How will this project lead to improvements in public health?

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

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

Current Budget Period Financial Progress: Status of obligation of current budget period funds and an estimate of unobligated funds projected provided on an estimated FFR.

New Budget Period Proposal:

Detailed operational plan for continuing activities in the upcoming budget period, including updated Measures of Effectiveness for evaluating progress during the upcoming budget period. Report listed by Research Aim/Project.

Project Timeline: Include planned milestones for the upcoming year (be specific and provide deadlines).

New Budget Period Budget: Detailed line-item budget and budget justification for the new budget period. Use the CDC budget guideline format.

Publications/Presentations: Include publications/presentations resulting from this CDC grant only during this budget period. If no publication or presentations have been made at this stage in the project, simply indicate “Not applicable: No publications or presentations have been made.

IRB Approval Certification: Include all current IRB approvals to avoid a funding restriction on your award. If the research does not involve human subjects, then please state so. Please provide a copy of the most recent local IRB and CDC IRB, if applicable. If any approval is still pending at time of APR due date, indicate the status in your narrative.

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.

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

Research Aim/Project Overview:  The PI should describe the purpose and approach to the project, including the outcomes, methodology and related analyses.  Include a discussion of the challenges, successes and lessons learned.  Describe the collaborations/partnerships and the role of each external partner.

Translation of Research Findings:  The PI should describe how the findings will be translated and how they will be used to promote, enhance or advance the research findings and the impact on public health policy and practice.  This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers and other potential end users.  The PI should also provide a discussion of any research findings that influenced policy or practice during the course of the project period.  If applicable, describe how the findings could be generalized and scaled to populations and communities outside of the funded project.

Public Health Relevance and Impact:  This section should address improvements in public health as measured by documented or anticipated outcomes from the project.  The PI should consider how the findings of the project related beyond the immediate study to improved practices, prevention or intervention techniques, policy, and technology or systems improvement in public health.

Publications; Presentations; Media Coverage:  Include information regarding all publications, presentations or media coverage resulting from this CDC funded activity.  Please include any additional dissemination efforts that did or will result from the project.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding 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
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Scientific/Research Contact(s)

Steve Dearwent, PhD
Centers for Disease Control and Prevention (CDC)
Telephone: 404-498-6382
Email: sed7@cdc.gov

Peer Review Contact(s)

Price Connor, PhD
Centers for Disease Control and Prevention (CDC)
Telephone: 404-498-2511
Email: spc3@cdc.gov

Financial/Grants Management Contact(s)

Peter Grandillo
CDC/OCOO/PGO
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Telephone: 412-386-6834
Email: png2@cdc.gov

Section VIII. Other Information

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Authority and Regulations

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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.


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