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	National Center of Excellence for the Prevention of Childhood Agricultural Injury (U54)
Activity Code	U54 Specialized Center- Cooperative Agreements
Announcement Type	Reissue of RFA-OH-08-006
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-OH-14-005
Companion Funding Opportunity	none
Number of Applications	Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.262
Funding Opportunity Purpose	This funding opportunity announcement (FOA) from the National Institute for Occupational Safety and Health (NIOSH) invites applications for a National Center of Excellence for the Prevention of Childhood Agricultural Injury.

Posted Date	February 19, 2014
Letter of Intent Due Date(s)	March 14, 2014
Application Due Date(s)	May 2, 2014
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June 2014
Advisory Council Review	June 2014
Earliest Start Date	September 2014
Expiration Date	May 3, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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 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

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.

Background and Purpose

This request for applications (RFA) builds on NIOSH s extensive history in efforts to prevent agriculturally-related injuries to children. Youth working in agriculture face risks not present for many other young workers. In agriculture, the workplace often includes a home; children often begin active work on farms at an early age; and recreational activities may occur in close proximity to, and concurrently with, work activities.

In April 1996, the National Committee for Childhood Agricultural Injury Prevention (NCCAIP) published a National Action Plan (Children and Agriculture: Opportunities for Safety and Health) to maximize the safety and health of all children and adolescents who may be exposed to agricultural hazards. The national plan called for developing collaborations among researchers and cooperative efforts among public and private sector organizations; ensuring that the public is aware of childhood agricultural safety and health issues; using consensus-building processes involving interdisciplinary experts and stakeholders to arrive at guidelines and recommended standards for research and workplace practices; and systematic evaluation of educational materials to ensure their effectiveness at reaching the intended audience.

Based on the National Action Plan, NIOSH undertook a Childhood Agricultural Injury Prevention Initiative in October 1996. In 1997, NIOSH began funding a national center for research, training, and education to prevent child agricultural injuries in the United States. This center was established at the National Children’s Center for Rural and Agricultural Health and Safety in Marshfield, Wisconsin. The center strives to enhance the health and safety of all children exposed to hazards associated with agricultural work and rural environments.

Other activities related to this initiative include surveillance (The NIOSH Childhood Agricultural Injury Surveillance Project), assessing ergonomic and workload hazards to children and adults, developing and publishing the North American Guidelines for Children's Agricultural Tasks (NAGCAT) as both a professional resource manual and as parent guideline posters, conducting training workshops for journalists, developing a NIOSH web site for Childhood Agricultural Injury Prevention, and funding extramural research grants and cooperative agreements in a variety of areas.

In 2001, a summit on childhood agricultural injury prevention reviewed progress in implementing the 1996 National Action Plan and updated the National Action Plan. The Progress Report and Updated National Action Plan from the 2001 Summit builds on the successes and shortcomings of the 1996 plan within the framework of (a) non-working children, (b) working children and adolescents, and (c) infrastructure and leadership. NIOSH continued to focus on extramural research projects related to children in agriculture by funding three projects in 2007 under a specific request for applications related to Childhood Agricultural Safety and Health Research. The following projects were funded: Refinement and Enhancement of Agricultural Safety Curricula for Children (REACCH), Georgia Childhood Agriculture Safety and Health Research, and Developing and Evaluating New Approaches to Youth Agricultural Injury Prevention.

In 2012, the Blueprint for Protecting Children in Agriculture was released as a follow-up to the national initiative launched in 1996. The Blueprint redefined current priorities to adjust for changes in production activities and population dynamics since the initial action plan was developed.

Continued Need for Efforts to Prevent Childhood Agricultural Injuries

Although substantial efforts have been undertaken to reduce and prevent childhood agriculture injuries, there remains a need to achieve a cohesive, consistent program for improving the safety and health of children and adolescents who are present where agricultural work occurs. Many youth live and work on farms, many farms are family-based operations, and all farming operations should provide a safe environment for the youth who are present.

In 2011, there were about 2.2 million farms operating in the U.S. with approximately 1 million youth living on these farms. More than half of these youth performed work on the farm and an additional 250,000 youth were hired to perform agricultural tasks. According to estimates from the USDA and NIOSH, there were an estimated 13,996 youth farm injuries in 2012.

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 NORA http://www.cdc.gov/niosh/nora/about.html. This program, established by NIOSH and its partners to stimulate innovative 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/

NORA Sectors and Cross-Sectors

Applicants must provide a statement about how application addresses childhood injuries and illnesses related to agriculture, which cross-sector(s) (http://www.cdc.gov/niosh/programs/) are being addressed, and a rationale for how the Center will contribute to the specified priority area (this information must be placed in the Project Description/Abstract).

R2P

In addition to NORA, 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 do the following:

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

Additional information about r2p can be found at: http://www.cdc.gov/niosh/r2p.

Outputs and Outcomes

Government agencies are faced with increasing demands to measure the effectiveness of their funded research in improving public health. Effectiveness is 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/Program Strategy Sections.

Approach

Building on prior NIOSH initiatives and the continued need for efforts in this area, a national center for the prevention of childhood agricultural injury is expected to 1) serve as a leader to facilitate prevention efforts and activities; 2) provide or enhance efforts to prevent injuries occurring to children who live on, work on, or visit farms, or are associated with other agricultural activities that pose a risk to children; 3) establish linkages and partnerships with the agricultural community to facilitate childhood agricultural injury prevention; 4) identify, disseminate, and facilitate the use of state-of-the-art information and programs to prevent childhood agricultural injuries; 5) provide recommendations, which incorporate input from the diverse stakeholders within childhood agricultural safety and health, for guiding childhood agricultural injury prevention efforts; and 6) conduct research to improve the safety and health of children who live on, work on, or visit farms.

The Center would accomplish its purpose by: enhancing the knowledge, attitudes, and practices of individuals, groups, and community-based organizations; establishing links and partnerships with agricultural communities to facilitate childhood agricultural injury prevention; and by identifying, disseminating, and facilitating the use of state-of-the-art information and programs to prevent childhood agricultural injuries. Important goals include evaluation of intervention effectiveness and translation of these interventions into a variety of agricultural workplace settings.

Priorities

Based on successes and shortcomings of efforts undertaken to date, priorities for outreach, education, translation, training, prevention, intervention, and research to reduce child and adolescent agricultural injuries and fatalities in the U.S. include, but are not limited to the following:

• Partnering with farmer-identified peer groups to raise awareness and improve dissemination of existing childhood farm safety resources and programs for non-working children and working youth (e.g. safe play areas, safety day camps, NAGCAT);
• Integrating information on prevention of childhood agricultural injuries into existing youth programs (e.g. bike safety, car seats) and professional training curricula (e.g. injury prevention courses; conference workshops);
• Developing effective networks and organization partnerships to address prevention of childhood agricultural injuries and fatalities via national-level initiatives, including public awareness campaigns;
• Testing interventions to improve safe working conditions for young workers, including hired adolescent farm workers, to prevent musculoskeletal strains, improve safe tractor operations, enhance machinery guarding, and increase use of personal protective equipment;
• Identifying and testing interventions to address parents and farm owners barriers to adopting known interventions for reducing childhood farm injuries, e.g., off-site childcare, safe play areas, adult supervision, safe work guidelines for youth (NAGCAT);
• Evaluating the economic consequences of childhood agricultural injuries;
• Improving exposure and morbidity surveillance of youth in agriculture;
• Improving engineering controls to reduce exposures of youth to agricultural hazards;
• Reducing the rates of injuries and fatalities to youth on farming operations in the U.S.;
• Evaluating and improving the adoption of evidence-based safety and health practices by a broad range of farming operations where children or adolescents are present;
• Accelerating the agricultural industry and associated organizations adoption of safety and health standards that protect children and young workers;
• Actively disseminating evidence-based practices to stakeholders via proactive collaborations, particularly in the areas of emerging issues, the application of data to guide interventions, child care options, outreach and interventions for high-risk and underserved populations, age-based work restriction guidance for parents and morbidity associated with cross-over work and recreational vehicles, and;
• Integrating school, home, and workplace educational practices to provide a cohesive, consistent program for improving the safety and health of children and adolescents who are present where agricultural work occurs.

Impact

The Center is expected to exert a transformative influence on childhood agricultural health and safety across the country. The research, prevention, intervention, outreach, education, translation and evaluation efforts of the Center should be focused on improving childhood health and safety on the farm. All levels of Center efforts are expected to have a direct tie to public health impacts whenever possible. NIOSH strongly encourages the use of suitable evaluation techniques/tools and follow-up actions to help assess impacts and outcomes.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIOSH staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New Renewal The OER Glossary and the PHS 398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	CDC/NIOSH intends to commit $1.2M in FY 2014 to fund one award.
Award Budget	It is anticipated that the total funds available for the entire project period will be approximately $6 million. The estimated total funding (direct and indirect costs) for the first year (12 month budget period) will be $1.2M.
Award Project Period	The anticipated project period for this cooperative agreement is five (5) years.

HHS 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

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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 PHS 398 Application Guide.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, see http://grants.nih.gov/grants/multi_pi.

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

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide. 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.

It is critical that applicants follow the instructions in the PHS 398 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.

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:

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

The letter of intent should be sent to:

Steve Dearwent, Ph.D.
Scientific Program Official
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road N.E., Mailstop E74
Atlanta, GA 30333
Telephone: 404-498-6382
FAX: 404-498-2571
Email: SDearwent@cdc.gov

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, any large appendix materials can be sent on a CD ROM disk to:

Nina L. Turner, Ph.D.
Scientific Review Official
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1095 Willowdale Road
Morgantown, WV 26505
Telephone: 304-285-5976
FAX: 304-285-6047
Email: NTurner@cdc.gov

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, except in cases where it conflicts with the page limitations and format as described in detail in the next section - "Instructions for the Submission of Multi-Component Applications." In these cases, always follow the specific guidance provided in this announcement.

The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a multi-component application.

• Applicants must use the PHS 398 version, and the instructions, which are current at the time of their application. The applications submitted in response to this announcement are complex. The scientific and programmatic information needed to properly assess them is not fully accommodated within the basic PHS 398. Consequently, applicants will need to modify and expand the PHS 398 to properly organize the necessary information for reviewers. To help facilitate an effective and efficient peer review process, each individual core, program or project (i.e. administrative/planning, research, prevention/intervention, outreach/education or evaluation) should constitute a complete, discrete unit within the application with minimal duplication elsewhere. All applicants should use the following outline:PHS 398 Face Page (Form Page 1)
• Form Page 1-continued (only if Multiple PD/PIs are proposed)
• Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells. Use Form Page 2, additional Project/Performance Site pages and additional continuation pages as needed.
• Complete Table of Contents
• Detailed Budget for the Initial Budget Period for the Entire Center (Form Page 4)
• Budget for the Entire Proposed Project Period (all years, all components Form Page 5)
• Biographical Sketch - Program Director/Principal Investigator
• Other Support for Program Director/Principal Investigator
• Biographical Sketches for Key Personnel
• Other Support for Key Personnel
• Resources (e.g. facilities, scientific environment, physical resources, etc., relevant to overall Center 6 page maximum)
• Overall Description of the Center (2 page maximum)
• Past Performance/Accomplishments in Last Project Period (2 page maximum for existing Center)
• Past Performance/Accomplishments Relevant to Proposed Center goals (2 page maximum for new applicants)
• Statement on the Institutional Commitment to the Center (1 page maximum)
• Identification of the States that will be involved with the project
• Human Subjects summary table that lists all the projects and human subjects information (project title, performance sites, FWAs, IRB approval date/status)
• Administrative and Planning Core Cover Sheet (with section title, PI Name and table of contents for the section)
• Administrative and Planning Core Description (see outline and page limits below)
• Outreach/Education Program Cover Sheet (with section title, PI Name and table of contents for the section)
• Outreach/Education Program Plans (A, B, etc. - see outline and page limits below)
• Prevention/Intervention Program Cover Sheet (with section title, PI Name and table of contents for the section)
• Prevention/Intervention Program Plans (A, B, etc. - see outline and page limits below)
• Research Projects Cover Sheet (with section title, PI Name and table of contents for the section)
• Research Project Plans (A, B, etc. - see outline and page limits below)
• Evaluation Program Cover Sheet (with section title, PI Name and table of contents for the section)
• Evaluation Program Plans (see outline and page limits below)
• Checklist
• Appendix

Outline and page limits for each section

Each core/program/project plan (admin and planning core, research projects, prevention/intervention program plans, outreach/education program plans, and evaluation program) constitutes a complete, discrete unit within the application, and should use the following outline:

• PHS 398 Face Page (Form Page 1)
• Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (PHS 398 - Form page 2)
• Table of Contents
• Highlights of Accomplishments for Past Project Period if an Existing Agriculture Center (2 page maximum)
• Highlights of Past Accomplishments Relevant to Proposed Center goals if a new applicant (2 page maximum)
• Detailed Budget for the Initial Budget Period for Individual Core, Program, or Project (Form Page 4)
• Budget for the Entire Proposed Period for Individual Core, Program, or Project (Form Page 5)
• Biographical Sketches for Program Directors/Principal Investigators
• Other Biographical Sketches
• Other Support
• Resources (facilities, scientific environment, physical resources)
• Research Plan (or Program Plan)
  • Introduction (for resubmission applications only, 1 page)
  • Specific Aims (1 page)
  • Research or Program Strategy (12 page limit)
  • Background and Significance
  • Innovation
  • Approach
  • Preliminary Studies
• References
• Targeted/Planned Enrollment Report (if applicable)
• Letters of Support
• Human Subjects
• Vertebrate Animals
• Consortium/Contractual Arrangements
• Resource Sharing Plan(s)
• Checklist

Type density and size of the entire application must conform to the limits provided in the 398 instructions on page 17. All pages should be numbered sequentially throughout the application beginning with the Face Page as Page 1. The U54 activity code uses ONLY the detailed Research & Related Budget - do not use the PHS 398 Modular Budget.

Center Components

The National Center of Excellence for the Prevention of Childhood Agricultural Injury must be more than a collection of individual projects. The Center is expected to have clear administrative oversight and management of all essential components, provide competent scientific and technical guidance on all projects, maintain the overall focus of the Center, and manage the progress and performance of each project. The Center should address agriculture issues in an integrated manner by identifying problems and their causes, developing evidence-based and effective solutions, and then promoting the adoption of these solutions. Therefore, under the heading Overall Description of the Center , the Program Director/Principal Investigator should clearly describe the theme or themes of the Center, how projects address the Center’s theme(s), and how the Center will function as an integrated program rather than simply a collection of projects. 

There must be a demonstrated commitment of the applicant's institution toward the support and encouragement of a National Center of Excellence for the Prevention of Childhood Agricultural Injury. Such support can be demonstrated by faculty release time, capital improvements to enhance or facilitate the operation of the Center, or assistance in acquiring relevant equipment, supplies or support personnel.

Essential Components

A National Center of Excellence for the Prevention of Childhood Agricultural Injury is expected to support a broad national program of coordinated outreach, education, translation, prevention, intervention, evaluation, and research. The Center is a synergistic effort that involves center-wide functions, core expertise in various areas, and individual projects clearly related to the mission of the Center and the priorities listed in this announcement.

While flexibility is allowed in the organizational structure and management of the Center, five components are considered essential for a fully functional Center. These are:

• Administrative, Management and Planning Core (about 25% of total budget)
• Outreach, Education, and Translation Program (about 25% of total budget)
• Prevention, Intervention, and Translation Program (about 20% of total budget)
• Research Projects (about 20% of total budget)
• Evaluation Program (about 10% of total budget)

These essential components must work cooperatively to address the objectives of the Center. The percentage allocated to each component is provided as a general guideline. Translation is listed in two categories 1) to emphasize its importance as a critical part of this Center, 2) because of the integrative nature of this field, and 3) because effective translation often results from a combination of outreach, education and intervention efforts.

Administration, Management and Planning Core (about 25% of annual budget)

This core encompasses overall administrative, management, and planning functions; internal and external advisory committees; and a pilot projects program. Certain Center-wide outreach functions (newsletters, overall outreach plan, etc.) may be included here. If an overall/Center-wide outreach plan is not included here, then it should be included under the Outreach, Education, and Translation Program.

The Administrative and Planning Core must have strong leaders who are: 1) committed to the program, 2) capable of providing scientific leadership, and 3) accept responsibilities for administering and integrating a national program. Assessment of the program's Program Director/Principal Investigator’s ability to lead a highly integrated program of outreach/education, prevention and intervention, and research will be a significant consideration in the evaluation of the application.

This group provides the administrative infrastructure for the entire Center and should not be duplicated within other core program areas. Responsibilities and activities include:

• Providing expertise, organizational support and facilities to conduct outreach, education, prevention, intervention, training, and research activities including seminars, workshops, reference collections, and computer support. Program Director/Principal Investigator should commit a minimum of 30% effort.
• Facilitating and encouraging the use of existing state and national databases. A data center/statistical support activity may be included if needed for the Center.
• Managing an Internal Advisory Committee to assist the Program Director/Principal Investigator (Center Director) in making program and administrative decisions about operations of the overall Center and serve as main points of coordination between program areas and projects. This committee should consist of the individual program leaders and research project leaders. These individuals will also assist the Center Director with strategic planning and evaluation efforts. Internal Advisory Committee members should have a minimum commitment of 10%.
• Appointing and managing an External Advisory Committee to provide overall guidance, advice and feedback to the Program Director/Principal Investigator (Center Director), program leaders, and research project leaders on current efforts and future directions of the Center. This committee should consist of recognized leaders in child agriculture safety, members of the agriculture Extension community, representatives from collaborative and partnership organizations, and members of the farming community or populations served by the Center.
• Supporting and managing pilot projects in outreach, education, translation, prevention, intervention, and research areas of the Center to sustain the quality, breadth, and dynamics of a national program. These projects should encourage investigation and development of creative approaches in outreach, education, prevention, intervention, and research.

Pilot projects are considered an important and integral part of support provided to the Center. Funds should be designated to provide support for short-term projects (12 months or less, up to $20,000 in total costs) to explore new areas in the Center's programs. This is an opportunity for new investigators to collect sufficient data to pursue support through other funding mechanisms. Pilot projects can include, but are not limited to:

• Providing initial support for new investigators to develop new or innovative approaches/lines of investigation in any of the program areas or emerging issues;
• Exploring innovative or new directions representing a significant departure from ongoing funded projects in agricultural sciences;
• Encouraging investigators from other fields of study to apply their expertise to child agricultural safety and health issues.

As a general rule, 10%-15% of the Administration, Management and Planning Core budget for each year should be allocated to the Pilot Projects Program of the Center. While management of the Center's Pilot Project Program resides with the Center’s Director, certain minimal requirements must be met including:

• Appropriate announcement of funding available for pilot projects and solicitation of proposals.
• Merit review of proposals. Copies of all proposals, with documentation of their reviews, relative ranking, and final action must be retained by the Center. These records must be available to the NIOSH/OEP Scientific Program Official.
• Providing written documentation to the NIOSH/OEP Scientific Program Official regarding compliance with human subjects rules and regulations.
• Recording and reporting results of each funded pilot project (abstract, publications, subsequent grant applications, etc.). This record should be available to the NIOSH/OEP Scientific Program Official and to reviewers participating in site visits conducted by NIOSH/OEP.
• Obtaining input from the Internal and External Advisory Committees for management of this program.

Outreach, Education, and Translation Program (about 25% of annual budget)

Outreach, education, and translation efforts comprise an essential part of the Center’s role to reach people who are in a position to improve the safety and health of children who live on, work on, or visit farms. Such efforts include building coalitions among organizations and groups with the potential to reduce the burden of childhood agricultural injury. Such efforts include having an overall outreach/communication plan for the Center and specific/targeted outreach programs or projects.

The program leader must be able to develop and lead highly integrated, collaborative outreach, education, translation, intervention, and training activities which are aimed at reducing and preventing childhood agricultural injuries. Further, the program leader must be able to build consensus among collaborators and partners regarding the direction and focus of the Center. The program leader must be able to identify key action steps needed to reduce and prevent childhood agricultural injuries. The program leader must be willing and able to engage and assist the private sector in becoming an acknowledged entity in childhood agricultural injury prevention. Periodic meetings to bring these groups (or components of these groups) together to raise awareness of issues, promote action, and achieve a "critical mass" of dedicated professionals to prevent childhood agricultural injuries are encouraged.

The translation of promising prevention or intervention findings into applied safety programs or demonstration programs through community services is a key role of the outreach/education component. Activities would include consulting with or training health and safety professionals, researchers, graduate/professional students, agricultural extension agents, vocational teachers, and parents, and others in a position to improve the safety and health of children who live on, work on, or visit farms. Essential functions of the outreach/education core include but are not limited to, coordinating and collaborating with established ongoing health communication efforts and convening consensus-development sessions to address complex and/or controversial issues with the aim of preventing childhood agricultural injuries.

Applicants should include well-developed education project plans to target key agricultural safety and health needs. This could include providing consultations or training to health and safety professionals, researchers, graduate/professional students, agricultural extension agents, vocational teachers, community of non-profit organizations, parents or others in positions to improve the safety and health of children. Clear monitoring or evaluation components should be included to determine the success of these programs in protecting children living, working, or visiting farms. These projects should be coordinated with the Prevention, Intervention, and Translation Program.

Projects should involve agricultural stakeholders in addressing educational needs and in the implementation of a monitoring component to determine the success of these projects in meeting those needs. Partnerships and collaborative relationships are encouraged across states, as well as with the NIOSH-supported Centers for Agriculture Disease and Injury Research, Education, and Prevention, NIOSH intramural programs, and other extramural partners including NIOSH-supported Education and Research Centers (ERCs), Training Project Grant (TPG) recipients, and Total Worker Health Centers as well as other NIOSH funded agricultural programs. In addition, when possible, collaborations with Agriculture Extension units and Vocational Agricultural Programs are encouraged as well as interactions with community-based organizations and other advocacy groups.

Prevention, Intervention, and Translation Program (about 20% of annual budget)

The function of this program is to actively engage target populations to determine effective intervention delivery methods. Suitable monitoring and evaluation components should be included to accurately determine the success and sustainability of these efforts. Direct input from agricultural stakeholders should be used to implement relevant and culturally appropriate activities which reduce or prevent childhood agricultural injuries. Strong partnerships with community organizations are encouraged to facilitate translating evidence-based interventions into effective, culturally appropriate actions.

Applicants should provide model programs, including prevention/intervention projects, for preventing or reducing injuries among children who live on, work on, or visit farms. Projects may include, but are not limited to, actions to prevent injury through combinations of techniques such as control technologies, exposure guidelines and regulations, worker participation programs, family-based interventions, and training.

Partnerships and collaborative relationships are encouraged among the National Center of Excellence for Childhood Agricultural Injury Prevention and the NIOSH-supported Centers for Agriculture Disease and Injury Research, Education, and Prevention, NIOSH intramural programs, other extramural partners including NIOSH-supported Education and Research Centers (ERCs), Training Project Grant (TPG) recipients, and other NIOSH funded agricultural programs. In addition, when possible, collaborations with state and county Agricultural Extension units and Vocational Agricultural Programs are encouraged. In addition to national-level activities, projects should specifically identify:

• the population of interest and relevant safety and health needs;
• mechanisms for establishing communication and active partnerships with local organizations, health care providers, educators, and community leaders;
• appropriate community-driven projects and approaches to identify potential risk factors; and
• the project approach and time frame to monitor the success of these prevention/intervention approaches in mitigating agriculture-related injury.

Research Projects (about 20% of annual budget)

Research projects are hypothesis-driven investigations focused on improving our understanding of agriculturally-related injuries to children and how to reduce or prevent them. Research projects should: target the priorities identified earlier in this announcement; involve multidisciplinary efforts to address important problems; avoid fragmentary efforts; and be clearly related to the mission of the Center. Surveillance, etiology, engineering, risk characterization, hazard or exposure assessment, analysis, intervention, translation, and dissemination are a few of the areas that may be included. Both field and lab projects may be considered.

Each research project proposal submitted as part of the Center application should be prepared as a separate, complete section because each one will be peer reviewed individually.

To be considered for funding, a Center application must have at least one research project proposal.

The significance of a project to the development and/or implementation of intervention efforts must be fully developed in the proposal.  Individual projects should identify the types and geographical distribution of the agricultural issue(s) which will be addressed.  The size and characteristics of populations which can potentially be impacted by the research findings should also be described.

Evaluation Program (about 10% of annual budget)

Evaluation is essential for both short- and long-term progress toward improving childhood agricultural safety and health. The NIOSH Agriculture, Forestry and Fishing Program had major evaluations in 1995 ( the Kennedy Report ) and 2007 ( the National Academies report ).  NIOSH also supports evaluation programs under the nine Centers for Agricultural Disease and Injury Research, Education, and Prevention funded through PAR-11-022.

Applications must incorporate appropriate evaluation activities at the program, project or overall center level and provide expected outputs and outcomes for each component evaluated. The Center has flexibility in developing a sensible, practical, and realistic Evaluation Program. Approach and rationale should be clearly explained in relevant sections of the application. Centers may balance evaluation costs between this component, individual projects, and other Center programs to help achieve cost savings or to gain maximum benefits from any given evaluation effort.

Evaluation is critical in reviewing, adjusting, refining, implementing, and improving a project, product, process, tool, practice or guideline. Questions like Does it work? Will they use it? Did it make a difference? How do we make it better? , and many others, require evaluation. Center Directors should consider consistent and realistic evaluation from the outset and facilitate collaborations between evaluation experts and project scientists or program managers. Organized, proactive approaches to evaluation that are considered from the beginning are likely to be the most useful, including the development of a logic model that can be followed and referenced throughout the process.

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

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

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.
As part of the initial merit review, all applications will receive a written summary statement consisting of:

• A summary evaluation of the Overall Center (considering all component Programs and Projects)
• A separate evaluation of the Administration, Management and Planning Core
• A separate evaluation of each plan within the Outreach/Education/Translation Program
• A separate evaluation of each plan within the Prevention/Intervention/Translation Program
• A separate evaluation of each Research Project
• A separate evaluation of the Evaluation Program

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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.

Review Criteria for Overall Center

(Inclusive Of the Administrative, Management and Planning Core; Outreach, Education, and Translation Program; Prevention, Intervention, and Translation Program; Evaluation Program, and all Research Projects)

An evaluation of prior performance will be reflected throughout all five scored criteria for the Overall Center component. For competing continuation applications, the evaluation will be based on performance and outputs since the previous competitive review. For new applications, this will be based on the history of prior related efforts and how well they complement the proposed Center’s program plans. The adequacy of the applicant’s record in activities and programs to protect children from injuries in agricultural settings and the degree to which these activities and programs have established the applicant as a recognizable entity in this area of occupational safety and health is paramount to this evaluation. The principal performance measure will be the historical success of the applicant in developing, testing, and implementing interventions to protect children and in the effectiveness of outreach and education activities. The impact and productivity of the applicant will also be measured through publications and creation and dissemination of educational materials by investigators, conferences, new funded research grants in agricultural injury prevention, new collaborations with other organizations, etc.

Significance: What is the potential impact of the Center in meeting the national and regional needs for childhood agricultural injury protection? Does the creation or continuation of the Center push forward this field of occupational safety and health, and is it a driving national resource? Does the Center address the needs of children working in agricultural environments?

Approach: Is the application cohesive and likely to achieve synergy and integration of the component programs? Is the proposed Center more than the sum of its parts, not just a collection of programs? Are the component programs and research projects well integrated with each other and designed to foster interdisciplinary interaction and national impact?

Innovation: What is the degree of innovation of the program? Does the Center propose new and innovative programs and maintain highly effective approaches to improving child agricultural safety and health?

Investigators: Are the qualifications of the Center Director and leadership team appropriate for managing a complex program in child agricultural injury protection in an institutional environment? Are the qualifications of the Program Leaders adequate to coordinate, oversee, and manage each component program, evidenced by training and record of accomplishments?

Environment: Is the quality, sufficiency, and multidisciplinary character of the education, intervention, and research environment adequate to accomplish the proposed activities? Is there evidence of institutional commitment to the Center?

Review Criteria for Administrative, Management and Planning Core

Adequacy of the Administrative, Management and Planning Core: Are there adequate overall plans for administration and management of the Center? Is the Center Director adequately supported and is there adequate management depth to provide long-term continuity of Center leadership? Does the administrative structure facilitate communication among the Center leaders and the project leaders? Are the plans for day-to-day management, allocation of funds, and cooperative arrangements designed to effectively achieve the goals of the Center?

Adequacy of External and Internal Advisory Committees: Are there appropriate plans for organizing and convening an External Advisory Committee to advise the Center leaders on the progress and the overall functional success of the Center? Are there appropriate plans for an Internal Advisory Committee drawn from Center staff to advise and assist the Center leaders?

Adequacy of the Outreach Plan: Does the plan adequately describe activities that will impact practitioners, farm environments, or other agencies and institutions that are involved with childhood agriculture issues? Is the plan National in scope? Does the plan facilitate the translation of occupational safety and health findings into the farm environment?  Are appropriate occupational safety and health constituents engaged in the program? 

Adequacy of Pilot Project Program: Are the goals for the program well described? Is the plan to conduct the Pilot Projects Program adequate? This includes the adequacy of procedures for reviewing and funding projects, the scientific review mechanism, and program quality assurance. Does the applicant describe the scope of the program and the eligibility of applicants? Is the plan for announcing the Pilot Projects Program funding adequate? Are there adequate plans for retaining copies of all pilot project applications, with documentation of merit reviews, relative ranking, and final action? Is there a mechanism for tracking the results of each Pilot Project study, i.e., by documenting publications, conference proceedings abstracts, subsequent related RO1/R21 submission to a DHHS Agency, dissertation, etc.)?

Review Criteria for Outreach, Education and Translation Program

Significance: Has the applicant provided documentation of merit and potential impact of the proposed program at the national and regional levels as determined by content, originality, feasibility, potential for success, and appropriateness for populations served by the Center?

Approach: Does the applicant describe the adequacy of the educational content and design, the formal training objectives, and the plans to meet the needs of both the practitioner community and the populations at risk? Do the investigators demonstrate knowledge of current practices and approaches for outreach and education? Do they describe adequate plans, methods, and activities for reaching target populations? Are there adequate plans to assess the success of outreach/education programs to prevent child and adolescent agricultural injuries? Are there plans for distributing results and products to appropriate stakeholders?

Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

Investigators: Are the qualifications and experience of the program leader and staff in areas relevant to the mission of the Center and outreach/education? Are individuals with strong subject matter skills playing key roles? Do personnel demonstrate knowledge of target audience needs in educational and outreach settings?

Environment: What is the availability of resources necessary to perform project objectives? What is the strength of commitment by the participating institution(s) as evidenced by provisions of appropriate resources, services, and technical support?

Review Criteria for Prevention, Intervention and Translation Program

Significance: What is the impact of the overall prevention/intervention program at the national and regional levels as determined by content, originality, feasibility, potential for success to improve protection, and appropriateness of populations targeted by the Center?

Approach: How strong are the overall strategies and methodologies employed by the program? Do the investigators demonstrate knowledge of current prevention-intervention strategies and methodologies? Do they acknowledge potential problem areas and consider alternative approaches? Do they describe adequate plans, methods, and activities for reaching target populations? Are the interventions used in this program informed by ongoing research? Are there adequate plans to assess the success of interventions on child and adolescent agricultural injuries? Are there plans for the distribution of results and products to appropriate stakeholders?

Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the program challenge existing paradigms or develop new methodologies or technologies?

Investigators: What are the qualifications and experience of the program leader and staff in areas relevant to the mission of the Center and the prevention/intervention program? Do individuals with strong subject matter skills play key roles? Do personnel demonstrate knowledge of the needs of their target audience?

Environment: What are the availability of resources necessary to perform project objectives? What is the strength of commitment by the participating institution(s) as evidenced by provisions of appropriate resources, services, and technical support?

Review Criteria for Individual Research Projects

Significance: Does this study address an important problem related to childhood agricultural injury prevention? If the aims of the project are achieved, how will scientific knowledge or clinical practice and the goals of the Center be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services or preventive interventions that drive this field?

Approach: Are the conceptual or clinical framework, design (including composition of study population), methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative approaches?

Innovation: Is the project original and innovative? For example, does the project challenge existing paradigms or clinical practice? Does it address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?

Investigators: Are the Program Director/Principal Investigator and key personnel appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the Program Director/Principal Investigator and other researchers?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Review Criteria for Evaluation Program

Adequacy of Center Evaluation: Does the application describe an adequate plan for the evaluation of scientific projects, the overall Center, and Center objectives to assess the effectiveness of the Center? Are there plans to obtain feedback from advisors, partners, stakeholders, or employers to assess the quality and effectiveness of childhood agricultural health and safety prevention, intervention, translation, promotion or protection programs?

Qualifications of senior leaders of the component: Does the senior leadership have appropriate experience and have they demonstrated effective and responsible leadership in the past? Is the percent effort requested adequate?

Qualifications of administrative staff: Are the qualifications, duties, and time commitments of administrative staff appropriate to contribute to the needs and conduct of the program’s outreach, education, prevention, intervention and research activities?

Institutional Commitment: Is there an adequate level of institutional commitment to effective, practical evaluation efforts? Do the proposed evaluation efforts reflect an established organizational component within the institution?

Contribution to Overall Center Program: Is the evaluation component an integral part of the Center? Are the approaches and rationales clearly explained in relevant sections of the application? Are evaluation efforts appropriately balanced between individual projects and other Center programs or cores to help achieve an economy of effort and gain maximum benefits?

As applicable for the Center 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 Center 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.

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

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

Revisions

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

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

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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), in accordance with NIOSH peer review policy and procedures , using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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 HHS Grants Policy Statement.

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. 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.

Overview of Terms and Conditions of Award and Requirements for Specific Types of Grants

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.

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

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

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:

Tobacco-free indoors no use of any tobacco products (including smokeless tobacco) or electronic cigarettes in any indoor facilities under the control of the applicant.

Tobacco-free indoors and in adjacent outdoor areas no use of any tobacco products or electronic cigarettes in any indoor facilities, within 50 feet of doorways and air intake ducts, and in courtyards under the control of the applicant.

Tobacco-free campus no use of any tobacco products or electronic cigarettes in any indoor facilities and anywhere on grounds or in outdoor space under the control of the applicant.

Nutrition:

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

http://www.cdc.gov/nccdphp/dnpao/hwi/toolkits/tobacco/index.htm

http://www.cdc.gov/chronicdisease/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

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 PD(s)/PI(s) will have the primary responsibility for the following:

• The Recipient will have the primary responsibility of all management, administrative, and scientific aspects of the research including all data, resources, and operations;
• Recipient Organization will retain custody of and have primary rights to the information, data and software developed under this award, subject to U.S. Government rights of access consistent with current HHS/CDC policies;
• The recipient will coordinate project activities, technically, scientifically, and administratively at the awarded institution and at other sites that may be supported by sub-contracts to this award;
• The applicant will have primary authority and responsibility to define objectives and approaches; to plan, conduct, and analyze data; and to publish results, interpretations, and conclusions of studies conducted under the terms and conditions of the program project award;
• Establish or enhance a National Center for programs, research, and information which have been shown to be effective in preventing childhood agricultural injuries;
• Establish and maintain contacts with organizations, groups, and individuals which supply childhood agricultural injury prevention information and data for use in targeting prevention efforts and prioritizing program needs;
• Facilitate awareness and utilization of the Center through appropriate activities, including but not limited to involving minority-serving groups, community-based organizations, and other relevant organizations;
• Coordinate and collaborate with established and ongoing health communication efforts, such as the National Safety Council's "Farm Safety and Health Week," "Farm Safety 4 Just Kids," and other relevant organizations as appropriate;
• Organize and manage multi-perspective work groups which use consensus-building processes to arrive at recommendations for the protection of youth who work on farms and the protection of bystander children who are exposed to farm hazards.
• Inform and facilitate the involvement of the private sector in childhood agricultural injury prevention activities;
• Collaborate with public and private sector agencies, community-based organizations, researchers, and other groups who can enact change through prevention efforts and activities;
• Conduct pilot research into the causes and prevention of childhood agricultural injuries;
• Monitor the success of the National Center for the Prevention of Childhood Agricultural Injury on promoting actions to prevent childhood agricultural injuries.

NIOSH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

NIOSH Scientific Program Official

NIOSH/CDC recognizes the potential need for assistance, when appropriate, in such a complex and diverse project. An HHS/CDC/NIOSH agency Scientific Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the NoA.

The Scientific Program Official will be responsible for objective, independent evaluation of the progress of the award in meeting its objectives. The Scientific Program Official will also be responsible for 1) ensuring that all requirements are met prior to issuance of an initial award, 2) objectively and independently evaluating progress toward specific aims or objectives, approving non-competitive continuation of the award, and 3) recommending corrective actions as needed.

The following types of activities will be available from NIOSH/CDC program staff:

• Technical assistance with program development, implementation, maintenance, priority setting, evaluation of efforts, enhancement of the Center, and information and dissemination activities.
• Links with researchers and public and private sector agencies and organizations to plan, implement, and evaluate childhood agricultural injury prevention efforts.
• Collaboration with the recipient in joint safety and health research, communication and dissemination efforts related to childhood agricultural injury prevention.
• Communication of new findings from NIOSH/CDC supported research.

NIOSH Project Scientist

A NIOSH Intramural Scientist will serve as a Project Scientist to provide substantial scientific involvement and subject matter expertise for agriculture safety, prevention, injury, or health. This person will assist in reporting or disseminating non-confidential research results, and relevant health and safety information, to appropriate Federal, State and local agencies, the scientific community, and other interested parties.

In accordance with HHS/CDC/NIOSH policies and guidelines, the NIOSH Project Scientist may publish with the awardee if mutually agreeable and warranted by the nature and extent of his/her intellectual contribution to the program or project.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the HHS Grants Policy Statement.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH 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.

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

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)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)

Contact Center Phone: 800-518-4726
Email: support@grants.gov

Hours: 24 hours a day, 7 days a week; closed on Federal holidays

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

Steve Dearwent, Ph.D.
Scientific Program Official
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road N.E., Mailstop E74
Atlanta, GA 30333
Telephone: 404-498-6382
FAX: 404-498-2571
Email: SDearwent@cdc.gov

Nina L. Turner, Ph.D.
Scientific Review Official
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1095 Willowdale Road
Morgantown, WV 26505
Telephone: 304-285-5976
FAX: 304-285-6047
Email: NTurner@cdc.gov

Mary Pat Shanahan
Centers for Disease Control and Prevention
OD, Environmental, Occupational Health and
Injury Prevention Services Branch - Team1
Procurement and Grants Office
P.O. Box 18070
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Telephone: 412-386-4453
FAX: 412-386-6429
E-mail: mshanahan@cdc.gov

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