United States Department of Health and Human Services (HHS)
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov)
Components of Participating
Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH), (http://www.cdc.gov/niosh/homepage.html)
Title: National Center of Excellence for the Prevention of Childhood Agricultural Injury (U54)
The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement 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.
Authority: This program is described in the Catalog of Federal Domestic Assistance and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. Awards are made under the authorization of the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670), Federal Mine Safety and Health Act, Section 501(a), 30 USC 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.
Announcement Type: New
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted using the most recently approved PHS 398 forms and the PHS 398 Application Guide.
Funding Opportunity Announcement (FOA) Number: RFA-OH-08-006Catalog of Federal Domestic Assistance Number(s):
Release/Posted Date: February 20, 2008
Letter of Intent Receipt Date: Not applicable.
Application Submission Receipt Date(s): April 10, 2008
Peer Review Date(s): April-May 2008
Council Review Date(s): May 2008
Earliest Anticipated Start Date(s): August 2008
Expiration Date: April 11, 2008
Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional Overview Content
The National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC) invites applications for a national center of excellence focused on preventing agricultural-related injuries to children.
Table of Contents
II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3.Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Request Application Information
2. Detailed Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application to CDC
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement
1. Recipient Rights and Responsibilities
2. HHS/CDC Responsibilities
3. Collaborative Responsibilities
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
4. General Questions Contact(s)
Section VIII. Other Information - Required Federal Citations
This request for applications (RFA) builds on prior NIOSH initiatives related to preventing agriculturally-related injuries to children. Agriculture generally encompasses growing crops, raising/harvesting animals on farms, ranches, or from their natural habitats. Agriculture may also extend to timber harvesting and aquaculture. Youth working in agriculture face risks not present for many other young workers, including tractors and other machinery, large animals, electrical hazards, chemical hazards and excessive noise. 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. This plan identified 13 objectives and 43 recommended actions for priority funding by the Federal government, foundations, agribusiness, and other public and private sector groups and nonprofit community-based organizations. 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 including: etiology, outcomes of youth farm work and injuries, intervention strategies, and evaluation of commonly used educational or training programs.
In 2001, a summit on childhood agricultural injury prevention reviewed progress in implementing the 1996 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. The progress report includes three primary goals and 12 recommendations on strategies and priorities related to childhood agricultural injury prevention. Five key principles guided the efforts undertaken at the summit meeting: education alone is insufficient for preventing injuries; evaluation strategies should be applied to existing and new programs and the results should drive program modifications; efforts should be made to enable farm families, rural schools, farm organizations and agribusinesses to plan and implement these recommendations; innovative strategies should be developed to match the diversity of people, production methods, and economic conditions affecting United States agriculture; and both successes and failures regarding research and program activities should be widely shared to maximize progress toward achieving our goals.
In 2003, NIOSH continued funding for a national center for research, training, and education to prevent child agricultural injuries in the United States this center continued with a second competitive award to the National Children’s Center for Rural and Agricultural Health and Safety in Marshfield, Wisconsin. The center provides a variety of resources and publications related to outreach and education, prevention and intervention, and research.In March 2005, five priorities for the North American Guidelines for Chilren’s Agricultural Tasks were identified as NAGCAT Priorities 2010. The include: address perceptions and barriers of NAGCAT users; revise and reformat a core set of the guidelines; develop a NAGCAT dissemination-marketing plan; create training and support materials for NAGCAT users; and conduct further research to facilitate accomplishing these priorities.
In 2007, NIOSH continued to focus on extramural research projects related to children in agriculture by funding three projects 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.
Continued Need for Efforts to Prevent Childhood Agricultural Injuries
Although substantial efforts have been undertaken to reduce and prevent childhood injuries related to agriculture in the past ten years, 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.
During 2001-2004, there were about 2 million farms operating in the U.S. Nearly one third of these (650,000) were reported as having youth less than 20 years old living on them. Estimates indicate that over 1.25 million youth live on these farms.
According to the U.S. Department of Agriculture, most U.S. farms (98 percent in 2004) are family farms (defined as operations organized as proprietorships, partnerships, or family corporations that do not have hired managers). Also, small family farms with sales less than $250,000 accounted for 90 percent of U.S. farms in 2004. Small farms make significant contributions to the production of specific commodities, including hay, tobacco, wheat, corn, soybeans, and beef cattle.
In 2004, NIOSH published the Worker Health Chartbook in which Chapter 3 (Focus on Agriculture) indicates that youths aged 15–19 accounted for the most unintentional on-farm deaths (742) during 1982–1996, and youths under age 5 accounted for the next highest number of these deaths (527). During 1992–2001, fatal occupational injury rates in agriculture (includes forestry and fishing) were 13.7 per 100,000 for workers aged 16–24. Surveillance data for 1995-2002 indicate that 907 youth died on farms (average of 113 deaths per year) with most between 16-19 years of age. The majority of deaths to youth on U.S. farms were due to machinery (23%), such as tractors; motor vehicles (19%), which include ATVs; and drowning (16%).
According to Injuries Among Youth on Farms, 2001, almost 17,000 youth considered to be part of the farm household were injured (16 injuries per 1,000 household youth) in 2001; 10-15 year olds had the highest injury rate (21 injuries per 1,000 household youth); 5,807 injuries occurred while working on the farm (10 injuries per 1,000 working household youth); and 10-15 year olds experienced the highest rate of injury while doing farm work (11 injuries per 1,000 household youth).
The National Agricultural Statistics Service indicated that about 3,800 injuries occurred to youth who visited farms. As would be expected, a large percentage of these injuries (about 77 percent) were classified as non work-related while 23 percent were considered to be work-related. Non work-related injuries largely involved slips or falls, encounters with livestock (horses, cows) or off-road, recreational use of vehicles such as ATVs or motorcycles.
Hard and Meyers (2006) reported 310 work-related deaths of youth < 20 years of age during 1992-2002 in the agriculture production sector as compared to 1,958 total fatalities for all workers less than 20 years of age for the same time period. While the number of fatalities generally decreased, the rates were higher for young workers in agriculture production than for young workers in all industries by a factor of 3.6. Fifteen year olds had the highest fatality rates with the crop production sector having a rate six times that of all 15 year old workers.
Farm tractors, farm machinery, stored grain, power lines, manure pits, ponds, and livestock are among the many hazards youth are exposed to in the agricultural workplaces. In addition to work activities, children and adolescents may be exposed to agricultural production hazards by virtue of living on a farm, accompanying their parents to work, or visiting farms.
2. Research Objectives
Building on prior NIOSH initiatives and the continued needs for efforts in this area, a national center for the prevention of childhood agricultural injury is to 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 outcomes include evaluation of intervention effectiveness and translation of interventions into a variety of agricultural workplace settings.
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:
1. 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);
2. 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);
3. Developing effective networks and organization partnerships to address prevention of childhood agricultural injuries and fatalities via national-level initiatives, including public awareness campaigns;
4. 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;
5. 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, work guidelines for youth (NAGCAT);
6. Evaluating the economic consequences of childhood agricultural injuries;
7. Improving exposure and morbidity surveillance of youth in agriculture;
8. Improving engineering controls to reduce exposures of youth to agricultural hazards;
9. Reducing rates and numbers of fatalities or injuries to youth on farming operations in the U.S.;
10. 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; and
11. 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.
1. Mechanism of Support
The HHS/CDC U54 is a cooperative agreement assistance instrument. Under the U54 assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and with HHS/CDC staff substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.
This FOA uses just-in-time concepts. It also uses only the detailed Research and Related Budget. Do not use the PHS Modular Budget page.
2. Funds Available
Funds Available and Anticipated Number of Awards. NIOSH intends to commit approximately $850,000 in new money for direct costs in FY 2008 to fund one Center application for up to five (5) years. Total costs are capped at $1.2 million dollars per year.
Although the financial plans of NIOSH provide support for this program, the award issued under this FOA is contingent upon the availability of funds and the submission of meritorious application(s) as judged by peer review evaluations of the individual components within the application and the overall Center application as a whole.
Continuation awards within an approved project period will be made based on satisfactory progress as evidenced by required reports and the availability of funds.
Applicants should include funds in their budgets for one trip per year to meet with NIOSH scientists and other childhood agricultural experts.
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application if your organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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 support.
2. Cost Sharing or Matching
Cost Sharing or Matching is not required.
The most current HHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/adminis/gpd/
3. Other-Special Eligibility Criteria
Applicants may submit only one Center application under this announcement.
If your application is incomplete or non-responsive to the special requirements listed in Section IV, it will not enter into the review process.
Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.
1. Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
435-0714, Email: GrantsInfo@nih.gov.
HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.
2. Detailed Content and Form of
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
TABLE OF CONTENTS FOR AN APPLICATION TO THIS RFA
Note: each project plan (research, prevention/intervention, and education/translation) should use the following outline:
(For pilot projects the aims, background, preliminary studies, progress report, and research design together cannot exceed 15 pages. For other projects, these items cannot exceed 25 pages)
Note: Type density and size of the entire application must conform to the limits provided in the 398 instructions on page 17.
Note: The CDC U54 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)
3. Special Requirements
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 from identifying problems, and their causes, to developing effective solutions that can be successfully implemented. Therefore, under the Heading “OVERALL DESCRIPTION”, 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.
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, 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, four components are considered essential for a fully functional Center. These are:
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 Core Program.
The Administrative and Planning Core must have strong leaders who are: 1) committed to the program, 2) capable of providing scientific leadership, 3) and who accept responsibilities for administering and integrating a national program. Assessment of the ability of the program's Program Director/Principal Investigator 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:
A. Providing suitable organization 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 (direct and in-kind).
B. 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.
C. 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 core 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%.
D. Appointing and managing an External Advisory Committee to provide overall guidance, advice and feedback to the Program Director/Principal Investigator (Center Director), core 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.
E. 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 core 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:
1) Providing initial support for new investigators to develop new or innovative approaches/lines of investigation in any of the core program areas;
2) Exploring innovative or new directions representing a significant departure from ongoing funded projects in agricultural sciences;
3) 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 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:
1) Appropriate announcement of funding available for pilot projects and solicitation of proposals.
2) 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 and to reviewers participating in site visits conducted by NIOSH/OEP.
3) Consultation with the NIOSH/OEP Scientific Program Official regarding compliance with human subject’s rules and regulations.
4) 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.
5) Obtaining input from the Internal and External Advisory Committees for management of this program.
Outreach, Education, and Translation Core Program (about 30% 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 along with 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 core. 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 evaluations 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 Core 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/CDC Centers for Agriculture Disease and Injury Research, Education, and Prevention, NIOSH/CDC intramural programs, and other extramural partners including NIOSH/CDC Education and Research Centers (ERCs), Training Project Grant (TPG) recipients, and other NIOSH/CDC funded agricultural programs. In addition, when possible, collaborations with Agriculture Extension units and Vocational Agricultural Programs are encouraged.
Prevention, Intervention, and Translation Core Program (about 25% of annual budget)
The function of this core 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/CDC Centers for Agriculture Disease and Injury Research, Education, and Prevention, NIOSH/CDC intramural programs, other extramural partners including NIOSH/CDC Education and Research Centers (ERCs), Training Project Grant (TPG) recipients, and other NIOSH/CDC 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:
1. the population of interest and relevant safety and health needs;
2. mechanisms for establishing communication and active partnerships with local organizations, health care providers, educators, and community leaders;
3. appropriate community-driven projects and approaches to inform the community of potential risk factors; and
4. describe 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, dissemination, and research to practice 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 stand alone, complete section because each one will be reviewed separately. Applications should follow the guidance for an R03 or the R21 which are stepping stones to the R01. These should be prepared using the SF398 form.
To be considered for funding, a Center application must have at least one approved research project.
The significance of a project and application 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 which will be addressed by a project. Finally, the size and characteristics of populations which can potentially be impacted by the research findings should be described.
Foreign Organizations are not eligible.
3. Submission Dates and Times
See Section IV.3.A for details.
3. A. Submission,
Review and Anticipated Start Dates
Letter of Intent Receipt Date: Not applicable.
Application Submission Receipt Date(s): April 10, 2008
Peer Review Date(s): April-May 2008
Council Review Date(s):May2008
Earliest Anticipated Start Date(s): August 2008
Expiration Date: April 11, 2008
3.A.1. Letter of
A letter of intent is not applicable to this funding opportunity announcement.
Applications must be prepared using the research grant
application forms found in the PHS 398 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)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies of the application and one CD ROM disk containing appendix materials (if any) must be sent to:
Charles N. Rafferty, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road NE, Mailstop E74
Atlanta, GA 30333
Telephone: (404) 498-2530
Overnight Mail Address:
2400 Century Parkway NE (4th Floor)
Atlanta GA 30345-3114
Applications must be received on or before the application submission receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.
Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
will not accept any application submitted to this funding opportunity that is
essentially the same as one currently pending initial merit review unless the
applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed.
Information on the status of an application should be checked by the Program Director/Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
Executive Order 12372 does not apply to this program.
All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Restrictions, which applicants must take into account while writing their budgets, are as follows:
Awardees upon acceptance of Notice of Award (NoA), must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI. "Award Administration Information”.
Applicants’ research plan(s) should address activities they will conduct over the entire project period.
The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.
Research Plan Component Sections
Your research plan must not exceed limits set in Section IV.2. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.
Special Instructions for Appendices
An appendix is permitted but should include only those materials appropriate for the proposed grant mechanism. Appendix materials should be supplied in the form of a PDF file contained on a CD ROM disk. Paper copies of appendix materials will not be accepted. The preparation of appendices should conform to the instructions described by the 11/2007 revision of the PHS 398 Instructions) and NIH Notice NOT-OD-08-031).
NIOSH (with AHRQ and NIH) has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.
Do not use appendices to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not the awardee will place any conditions on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.
All applicants must include a plan for sharing research
data in their application. Applicants should consult the HHS/CDC data sharing
policy available for additional
requirements on release and sharing of data (under Additional Requirements
25). All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
HHS policy requires that
grant award recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (refer to related HHS Grants Policy Statement). Investigators
responding to this funding opportunity should include a plan for sharing
research resources addressing how unique research resources will be shared or
explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by the HHS/CDC Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate scientific peer
review group convened by NIOSH in accordance with standard DHHS peer review
As part of the initial merit review, all applications will:
All applications will then be evaluated for programmatic relevance by the NIOSH Secondary Review Committee.
A site visit to the applicant institutions may be made to evaluate the overall merit of the application. If done, the site visit team would include members of the Special Emphasis Panel with expertise in the major program areas of the proposed Center, the NIOSH Scientific Review Administrator, and the NIOSH Scientific Program Official.
A site visit is not a prerequisite for consideration of an application by NIOSH. Therefore, the application is considered a complete document for review purposes. If a site visit is conducted, it provides an opportunity for the Program Director/Principal Investigator and associates to elaborate on the research program, cost effectiveness and quality control features, and on other Center activities for which funding is requested, as well as to answer reviewers' questions. The site visit team will not consider additional research projects or investigators, major revisions or amendments to the application, or any component which has not been included in the application. Budgetary changes also will not be considered during a site visit. Findings of the site visit team are reported and discussed by the members of the SEP, which makes the final peer review recommendations and assigns the priority score.
Initial Review Group Considerations
The goals of the NIOSH research program are to develop an understanding of the risks and conditions that are associated with occupational diseases and injuries, to explore methods for reducing risks and for preventing or minimizing exposure to hazardous conditions in the workplace, and to translate significant scientific findings into prevention practices and products that will effectively reduce work-related illnesses and injuries. Specific research priorities are derived from the National Occupational Research Agenda (NORA) which is used by NIOSH for determining how best to carry out its mission of providing national and world leadership in preventing work-related illnesses and injuries. Detailed information about NORA can be found at http://www.cdc.gov/niosh/nora/. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Review Criteria for Overall Center (Inclusive Of the Administrative, Management and Planning Core; Outreach, Education, and Translation Core Program; Prevention, Intervention, and Translation Core Program; and All Research Projects)
Significance: The 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 the major significant childhood populations in agricultural environments?
Past Performance: The adequacy of the record of the Center in activities and programs to protect children from injuries in agricultural settings and the degree to which the Center has established itself as a recognizable entity in this area of occupational safety and health. The principal performance measure will be the success of the Center in developing, testing, and implementing interventions to protect children and in the effectiveness of outreach and education activities. The impact and productivity of the Center will also be measured through publications and creation and dissemination of educational materials by Center investigators, conferences, new funded research grants in agricultural injury prevention, new collaborations with other organizations, etc. For competing continuation applications, the evaluation will be based on information submitted since the previous competitive review. For new applications, this will be based on the history of prior related efforts and the proposed Center program plans.
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: 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: The qualifications of the Center Director and leadership team in managing a complex program in child agricultural injury protection in an institutional environment. The qualifications of the Program Leaders and to coordinate, oversee, and manage each component program, evidenced by training and record of accomplishments.
Environment: Quality, sufficiency, and multidisciplinary character of the education, intervention, and research environment. 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 Core Program
Significance: The 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: 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: Qualifications and experience of the program leader and staff in areas relevant to the mission of the Center and outreach/education. Individuals with strong subject matter skills are expected to play key roles. Personnel should demonstrate knowledge of target audience needs in educational and outreach settings.
Environment: Availability of resources necessary to perform project objectives. 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: 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: The adequacy of 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 problems 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: Qualifications and experience of the program leader and staff in areas relevant to the mission of the Center and the prevention/intervention program. Individuals with strong subject matter skills are expected to play key roles. Personnel should demonstrate knowledge of the needs of their target audience.
Environment: Availability of resources necessary to perform project objectives. 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; 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?
Additional Review Criteria
In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the “Human Subjects Sections” of the PHS398 Research Plan.
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan component.
and Use of Vertebrate Animals in Research: If
applicants plan to use vertebrate animals in the project, HHS/CDC will assess
the five items described in the Vertebrate Animals of the Research Plan
component. Additional HHS/CDC
Requirements under AR-3 Animal Subjects Requirements are available on the
Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Biohazards: If applicants propose the applicant has proposed materials or procedures that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The evaluation of the budget should not affect the priority score.
Data Sharing Plan: The reasonableness of the data sharing plan may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy.
HHS policy requires that recipients of grant awards make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. Please see http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs. Investigators responding to this funding opportunity should include a plan addressing how unique research resources will be shared or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (HHS/PHS 2590 http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.
3. Anticipated Announcement and Award Dates
1. Award Notices
After the peer review of the application is completed, the applicant organization will receive a written critique called a “Summary Statement.” The applicant organization and the PD/PI will be able to access the Summary Statement via the eRA Commons.
CDC/NIOSH will contact all applicants being considered for funding to request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
Formal notification will be provided in the form of a Notice of Award (NoA) to the applicant organization. The NoA signed by the Grants Management Officer (GMO) is the authorizing document for the award. CDC/NIOSH will mail and/or e-mail this document to the recipient fiscal officer identified in the application.
Selection of the application for award is not an authorization to begin performance. Preaward costs are not allowed. See also Section IV.5. Funding Restrictions.
Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about
requirements. For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
Additional requirements are available Section VIII.
Other Information of this document or on the HHS/CDC website at the following
Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
These will be incorporated into the NoA by reference.
The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courtesy copy to the PD/PI at the time of award.
2.A. Cooperative Agreement
The following terms of award are in addition to, and not
in lieu of, otherwise applicable Office of Management and Budget (OMB)
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS/CDC grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement U54 an "assistance" instrument (rather than an "acquisition" instrument), in which substantial HHS/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; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the HHS/CDC may share specific tasks and activities, as defined above.
2.A.1. Recipient Rights and Responsibilities
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. The recipient will:
Establish and 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 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:
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.
The NIOSH Project Scientist will be named in the NoA and will work closely with the grantee and the Scientific Program Official.
2.A.5. Arbitration Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and HHS/CDC/NIOSH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIOSH staff voting, one NIOSH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
Recipient Organization must provide HHS/CDC with an original, plus two hard copies of the following reports:
1. 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, no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application
2. Annual report suitable for public distribution submitted to NIOSH/OEP Scientific Program Official.
3. Financial status report, no more than 90 days after the end of the budget period.
4. Final financial and performance reports, no more than 90 days after the end of the project period.
Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this FOA.
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.
HHS/CDC encourages your inquiries
concerning this FOA and welcomes the opportunity to answer questions from
potential applicants. Inquiries can fall into three areas: scientific/research,
peer review, and financial or grants management issues:
1. Scientific/Research Contact:
W. Allen Robison, Ph. D.
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 USA
Email: WRobison@cdc.gov and copy OEPCorrespond@cdc.gov
Overnight Mail Address:
2400 Century Parkway NE (4th Floor)
Atlanta GA 30345-3114
2. Peer Review Contact:
Stephen Olenchock, Ph.D.
MORG Bldg L Room 1116
1095 Willowdale Road
Morgantown, WV 26505
3. Financial or Grants Management Contact:
Peter Grandillo Jr.
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Telephone: (412) 386-6834
FAX: (412) 386- 6429
4. General Questions Contact:
Technical Information Management Section
CDC Procurement and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Human Subjects Protection
Federal regulations (45 CFR Part 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Use of Animals in Research
Recipients of PHS support for activities involving live, vertebrate animals must comply with the PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable. Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements can be found at http://www.cdc.gov/od/pgo/funding/ARs.htm.
Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research
It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.
Inclusion of Persons Under the Age of 21 in
The policy of CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including persons under the age of 21. If persons under the age of 21 will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.
In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.
The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.
The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.
HIV/AIDS Confidentiality Provisions
Recipients must have confidentiality and security provisions to protect data collected through HIV/AIDS surveillance, including copies of local data release policies; employee training in confidentiality provisions; State laws, rules, or regulations pertaining to the protection or release of surveillance information; and physical security of hard copies and electronic files containing confidential surveillance information.
Describe laws, rules, regulations, or health department policies that require or permit the release of patient-identifying information collected under the HIV/AIDS surveillance system to entities outside the public health department; describe also the measures the health department has taken to ensure that persons reported to the surveillance system are protected from further or unlawful disclosure.
Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.
HIV Program Review Panel Requirements
Compliance with Content of AIDS-Related Written Materials, Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions (June 1992) is required.
To meet the requirements for a program review panel, you are encouraged to use an existing program review panel, such as the one created by the State health department's HIV/AIDS prevention program. If you form your own program review panel, at least one member must be an employee (or a designated representative) of a State or local health department. List the names of the review panel members on the Assurance of Compliance form, CDC 0.1113. Submit the program review panel's report that all materials have been approved.
If the proposed project involves hosting a conference, submit the program review panel's report stating that all materials, including the proposed conference agenda, have been approved. Submit a copy of the proposed agenda with the application.
Before funds are used to develop educational materials, determine whether suitable materials already exist in the CDC National Prevention Information Network (NPIN).
Ensure that all STD or HIV infected patients enrolled in the proposed project will be linked to an appropriate local care system that can address their specific needs, such as medical care, counseling, social services, and therapy.
Public Health System Reporting Requirements
This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:
A. A copy of the face page of the application.
B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:
1. A description of the population to be served.
2. A summary of the services to be provided.
3. A description of the coordination plans with the appropriate state and/or local health agencies.
If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.
Paperwork Reduction Act Requirements
Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).
Smoke-Free Workplace Requirements
HHS/CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.Healthy People 2010
The Public Health Service (PHS) is
committed to achieving the health promotion and disease prevention objectives
of "Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at www.healthypeople.gov
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.
In addition no part of HHS/CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.
Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.
The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation
It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.
Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.
Prohibition on Use of HHS/CDC Funds for Certain Gun Control Activities
The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."
Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.
In addition to the restrictions in the Anti-Lobbying Act, HHS/CDC interprets the language in the HHS/CDC's Appropriations Act to mean that HHS/CDC's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.
Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.
It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.
Proof of Non-profit Status
Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.
Security Clearance Requirement
All individuals who will be performing work under a grant or cooperative agreement in a HHS/CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardees employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at HHS/CDC must undergo a security clearance process.
Small, Minority, And Women-owned Business
It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:
1. Place small, minority, women-owned business firms on bidders mailing lists.
2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.
The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.
The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).
Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.
Compliance with Executive Order 13279
Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations. All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS. If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance. A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above. A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols. In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization=s name, select its board members on a religious basis, and include religious references in its organization=s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities. For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site: http://www.whitehouse.gov/government/fbci/
Health Insurance Portability and Accountability Act Requirements
Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions. The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency. HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.
Release and Sharing of Data
The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the HHS/CDC data sharing agreement will be released as follows:
a. In a timely manner.
b. Completely, and as accurately as possible.
c. To facilitate the broader community.
d. Developed in accordance with CDC policy on Releasing and Sharing Data.
April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, http://www.whitehouse.gov/omb/circulars/a110/a110.html and Freedom of Information Act (FOIA) http://www.hhs.gov/foia/.
Applications must include a copy of the applicant's Data Release Plan. Applicants should provide HHS/CDC with appropriate documentation on the reliability of the data. Applications submitted without the required Plan may be ineligible for award. Award will be made when reviewing officials have approved an acceptable Plan. The successful applicant and the Program Manager will determine the documentation format. HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.
National Historic Preservation Act of 1966
The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:
The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking, shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register. The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.
b. Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”
Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.
Conference Disclaimer and Use of Logos
Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:
“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention (CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) . The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”
Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003). Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer. It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.
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