Part I Overview Information

Department of Health and Human Services

Participating Organizations
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov/)

Components of Participating Organizations
National Institute for Occupational Safety and Health (NIOSH), (http://www.cdc.gov/niosh/homepage.html)

Title: Centers for Agricultural Disease and Injury Research, Education, and Prevention (U50)

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
This is a modification of RFA-OH-03-002 that was previously released April 3, 2003.

Update: The following update relating to this announcement has been issued:

Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PAR-06-057

Catalog of Federal Domestic Assistance Number(s)
93.262

Key Dates
Release Date: November 3, 2005
Letters of Intent Receipt Date(s): Annually on January 15   (Now October 30 each year per NOT-OH-06-007)
Application Receipt Dates: Annually on February 15   (Now November 30 each year per NOT-OH-06-007)
Peer Review Date(s):  February/March, each year
Council Review Date(s): May, each year
Earliest Anticipated Start Date: July 1, each year
Expiration Date: December 21, 2009             

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The purposes of the Agriculture Centers are to conduct research, education, and prevention/intervention programs that address agricultural safety and health problems in the geographic region served (multi-state), as well as nationally.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) 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. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  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 Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. CDC Responsibilities
      3. Collaborative Responsibilities
      4.
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)
  4. General Questions

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

SectionI. Funding Opportunity Description

1. Research Objectives

Purpose

NIOSH is interested in receiving Center (U50) cooperative agreement applications that address the etiology and prevention of injuries resulting from production agriculture/forestry/fishing.  The purpose of this cooperative agreement program is to strengthen the occupational and public health infrastructure by building on more than a decade of Agricultural Center accomplishments aimed at integrating resources for occupational safety and health research and public health prevention programs at the State and local levels.  Applications should address the risks from agriculture activities through research, prevention/intervention, and education projects that as a whole address problems in a synergistic manner resulting in a measurable impact on agriculture related injuries and diseases.  Centers activities should be designed to integrate research, education, and prevention projects that address unique problems of agriculture in the geographic region served as well as nationally. 

Background

Agriculture consistently ranks among the industries with the highest rates of work related injuries and deaths in the United States. For agriculture families, these injuries often have severe economic consequences as there is no one who can replace the injured worker.  This loss can result in the loss of family operated farms and fishing vessels.  Furthermore, the agricultural environment presents a number of unique work settings which vary across the United States.  As a result, the risks of injuries and prevention/intervention strategies will also be very different.  For example, the injury risks associated with dairy farming are different from Alaska fishing.  In addition, this is the only industry in which the workplace is often also a home.  To address the many diverse occupational safety and health risks posed by the varied agriculture work settings, the Agriculture Centers program is being continued to address the problems in a multidisciplinary and integrated manner.

Despite many safety advances in the three agriculture settings, this industry consistently ranks as one of the most hazardous industries in the United States.  Acute traumatic injury and death are among the most significant and striking occupational hazards in agriculture.  There were approximately 26 deaths per 100,000 workers in the agricultural sector [production/forestry/fishing] during 1999.  The average annual fatality rate for the United States civilian working population for this same time period was approximately 5 deaths per 100,000 workers.   Of special concern are the number of children killed each year (over 100) while involved in farm activities.  During 1993, approximately 201,000 work-related, lost-time injuries occurred on U. S. farms, nearly 10 injuries for every 100 farms.  Similar injury risks are observed for fishing.   Individuals who work in agriculture are also at increased risk for occupational morbidity from musculoskeletal disorders, certain cancers, reproductive disorders, dermatological conditions, zoonotic diseases, hearing loss, stress related mental disorders, and occupational lung diseases.   Farm tractors, farm machinery, stored grain, power lines, manure pits, and livestock are among the many injury hazards workers are exposed to in the agricultural workplaces.

To guide NIOSH, a National Occupational Research Agenda (NORA) was created in 1996.  NORA is a vision of the Institute to conduct occupational safety and health research to adequately serve the needs of workers in the United States.  During the development of the Agenda, the importance of sector-specific research (including agriculture) was emphasized:  Sector-focused research has had much success and continues to hold great promise for gathering and translating knowledge and information into prevention.  A cross-cutting, matrix approach for targeting research in some or all of the 21 NORA priority areas has been recommended for the agricultural sector.  See: http://www.cdc.gov/niosh/nora/.

Priorities

The agriculture occupational environment is diverse, reflecting the many types of activities conducted for production agriculture/forestry/fishing. Reflecting this diversity, a number of agriculture research topics have been identified as priorities that include, but are not limited to, the following:

1.  Projects to reduce the rate of unintentional fatalities;
2.  Projects to reduce the number of unintentional injuries;
3.  Projects to reduce the number of unintentional acute occupational pesticide poisonings;
4.  Projects to reduce pesticide illnesses;
5.  Development of new pesticide biomarkers that are inexpensive, reliable, and readily available to health care professionals;
6.  Projects to reduce the incidence of respiratory disease;
7.  Approaches for increasing the proportion of farm machinery with power-take-off (PTO) shields in place used on farms in the US;
8.  Approaches for increasing the proportion of farm operators using fall protection in their farm buildings (e.g., barns, silos, grain bins);
9. Approaches for increasing the proportion of livestock operators who use appropriate animal handling facilities;
10. Intervention/prevention projects to reduce the rate of nonfatal injuries to youth on farming operations in the US;
11. Education/outreach projects to increase the knowledge of effective occupational safety and health interventions for agricultural workers;
12. Interventions for increasing the use of hearing protective devices and other strategies for reduction of noise exposure;
13. Projects to reduce machine related fatalities through intervention/prevention approaches;
14. Development of better methodologies for exposure and morbidity surveillance in agriculture;
15. Improved engineering controls for reducing exposure to bioaerosols in animal confinement facilities;
16  Intervention projects to reduce adverse safety and health events in migrant/seasonal farmworkers;
17. Surveillance and intervention/prevention strategies for reducing helicopter logging injuries.

Project Goals

Note: For this PAR, the term “Projects” is defined to include research, intervention/prevention, and education/translation research activities.  

This initiative is intended to assemble a cross-disciplinary, multi-institutional, and geographically diverse group to address the current issues in agricultural safety and health.  To accomplish this objective, it is envisioned that an Agriculture Center would:

1. Conduct research studies related to the prevention of occupational disease and injury among agricultural producers, workers and their families.

2.  Develop, implement and evaluate education projects for promoting health and safety for production agriculture/forestry/fishing including farmers, workers and their families.  This would include providing consultation and/or training to researchers, health and safety professionals, graduate/professional students, and agricultural extension agents and others in a position to improve the health and safety of agricultural workers.

3.  Develop, implement and evaluate model programs for the prevention of illness and injury among agricultural producers, workers and their families.

4.  Develop linkages and communication with other governmental and non-governmental bodies involved in agricultural health and safety with special emphasis on communications with other agricultural health and safety programs.

The emphasis of the Agriculture Centers should be on addressing priority, regional (multi-state) occupational health and safety problems using a multi-disciplinary approach.   Emphasis should also be given to populations not well represented in the current research such as hired laborers, migrant/seasonal workers, women and children.

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.   The size and characteristics of populations which can potentially be impacted by the research findings should be described.   Projects should include measures for assessing the impact on the disease, illness or injury targeted.

Intervention- Evaluation

Intervention/prevention and, to the extent possible, education/translation projects should include process and outcome measures.  Process measures must be detailed enough to allow for replication in other areas.  Outcome measures of interest include, but are not limited to: exposure to injury hazards, knowledge of safety and health hazards, documenting safety and health behavior change, and changes in the incidence of disease, injury, or fatality.  Evaluation of the results of these projects will guide future decisions to implement programs which have demonstrated success in reducing injury and disease.

Consultation/collaboration

In the development and prioritization of the project topics for the Agriculture Center, applicants are encouraged to consult with regional (multi-state) stakeholders (e.g. agricultural organizations, advisory groups, workers, and other interested parties).

Agriculture Centers should include the development, implementation and evaluation of model education and intervention programs promoting health and safety for agricultural workers and their families.  These programs should include culturally-appropriate materials (such as, consideration of language) and multi-media presentations, as appropriate, to reach the target agricultural populations within the Agriculture Center Region.

Agriculture Centers should include plans to provide assistance and direction to community-based groups in the region (e.g. farm youth or adult associations, extension services, schools, local government groups, migrant worker groups, medical clinics or treatment centers, worker associations, etc.) for the development and implementation of community projects including intervention research and prevention demonstration projects for preventing work-related injuries and illness among farm workers and their families.

Agriculture Centers should include plans to develop linkages and communication with other governmental and non-governmental bodies involved in agricultural health and safety, with special emphasis on communications and collaborations with other CDC/NIOSH-sponsored agricultural health and safety programs.

Useful References:

National Institute for Occupational Safety and Health.  National Occupational Research Agenda. Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No.96 115 (http://www.cdc.gov/niosh/nora/).

The NIOSH Agricultural program is a multi-faceted program.  For information on programs supported in the past, discussions of the vision, or future direction of the program, contact the NIOSH Agricultural Coordinator (name and contact information in the Inquiries Section).

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement. 

SPECIAL REQUIREMENTS

The essential characteristics of an Agricultural Center cooperative agreement are listed below:

Overall Characteristics

Four Essential Components

The Agricultural Center cooperative agreement will support a broadly based multi-disciplinary research, prevention/intervention, and translation program.  An Agriculture Center is expected to have the following components that together address the objectives of a Center:

1. Administrative, Planning and Outreach Core.
This component should NOT exceed $200,000 of the direct cost budget.

2. Research Projects.
These projects should be at least 30% of the direct cost budget.

3. Prevention/Intervention Projects. 
These projects should be at least 20% of the direct cost budget.

4. Education/Translation Projects.
These projects should be at least 20% of the direct cost budget.

(Projects may overlap these arbitrary divisions.  For example an intervention project may also fit as a translation project.  Thus, these are intended as guidelines to help the principal investigator balance the Agricultural Center’s projects).

Commitment

There must be a demonstrated commitment of the applicant’s institution to support and encourage the Agricultural Center.  Such support could be demonstrated by release time of faculty, capital improvements that will facilitate the program, and/or assistance in the acquisition of scientific equipment and supplies.

The Agricultural Center’s program should be more than a collection of projects, but rather should include a process for the administrative integration and oversight of the projects.  The projects should address agriculture issues in an integrated manner that contributes to the overall focus of the Center.  Ideally, an Agricultural Center will address the entire continuum of a problem from identification/causation through translation.  Therefore, under the Heading “OVERALL DESCRIPTION”, the 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. 

ESSENTIAL ELEMENTS OF AN AGRICULTURAL CENTER

ADMINISTRATIVE, PLANNING AND OUTREACH CORE
(SHOULD NOT EXCEED $200,000 OF THE ANNUAL DIRECT COST)

The Administrative, Planning and Outreach Core must have strong leaders committed to the program, who are capable of providing scientific leadership for the administration and integration of the program.  Assessment of the ability of the program’s principal investigator to lead a highly integrated program of research, prevention/intervention, and translation projects will be a significant consideration in the evaluation of the application. 

The Administrative, Planning and Outreach Core support the administrative infrastructure for the entire program and should not be duplicated within any other components.  The responsibilities and activities for this core include:

A.  Appropriate and adequate organization and facilities for activities such as seminars, workshops, reference collection and computer support, etc.  The principal investigator should provide a minimum of 15% time commitment (direct and in-kind).  

B. Feasibility/Pilot Projects. Support of feasibility/pilot projects in the research, prevention/intervention and translation project areas within the NIOSH Agricultural Center is considered fundamental to sustaining the quality, breadth, and dynamics of this program.  Investigators should include a minimum of $50,000 annually in direct cost for these projects.  These projects are intended to lead to the development of new and creative research, prevention/intervention and education/translation projects, and are considered an important and integral part of the support provided to the Agriculture Center. Therefore, funds should be designated to provide support for short-term projects (maximum duration of 12 months and $20,000).  This will also enable investigators to collect sufficient data to pursue support through other funding mechanisms.  Examples of feasibility/pilot projects may include but are not limited to:

  1. Provide initial support to develop innovative approaches/lines of investigation in the program areas.
  2. Allow exploration of possible innovative new directions representing a significant departure from ongoing funded projects in agriculture sciences (research, prevention/intervention, and translation).
  3. Stimulate investigators from other fields of study to apply their expertise to agriculture safety and health issues.
  4. Develop new mechanisms for external or multi-Center collaborative partnerships to address emerging agriculture safety and health concerns.
  5. Provide initial support for a translational activity.

While the administrative framework for management of the Center's Feasibility/Pilot Projects Program is left to the Center Director's discretion, certain minimal requirements must be met.  Management of the program must include provisions for:

  1. A mechanism that ensures preparation and appropriate announcement of the availability of feasibility/pilot project funding.
  2. A mechanism for merit review of feasibility/pilot project 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 reviewers in the event of a site visit.
  3. A mechanism to maintain a record of subsequent results of each feasibility/pilot project study (abstract, RO1/R21 submission, etc.) recipient.  This record must be available to reviewers in the event of a site visit for competing renewals

C.  The use of existing state and national databases is encouraged; however, a data center/statistical support activity may be included in the administrative core if needed for the Center.

D.  Outreach Activities:  A minimum of $30,000 of the direct cost budget for each year should be allocated to the Outreach Program.  Essential functions of the outreach component of the administrative core include but are not limited to, coordinating and collaborating with agriculture researchers, industry stakeholders, unions and other organizations to identify key issues and needs.  They could also include ongoing agriculture communication efforts and convening consensus-development sessions to address complex and/or controversial issues with the aim of preventing agriculture injuries and illness. 

E.  An Internal Advisory Committee is formed from the individual project leaders, one from each type of project (research, prevention/intervention and translation) that will assist the principal investigator in making scientific and administrative decisions in the operation of the program. 

F.  An External Advisory Committee comprised of at least three members who are recognized leaders in agriculture health and safety and regional agriculture experts, will provide overall guidance and advice to the principal investigator and program investigators on program direction.  This committee should meet annually to review the agriculture center’s progress. .  Input by both the Internal Advisory Committee and the External Advisory Committee into the management of the Feasibility/Pilot Projects Program is strongly recommended.

TYPES OF PROJECTS

Note:  Principal investigators are reminded that the intent of the Agriculture Center is not to support a collection of projects (research, prevention/intervention, and education/translation).  Rather, the goal for a NIOSH Agriculture Center is to support multi-disciplinary projects that are focused on a agriculture issue(s) in such a way as to have a meaningful and measurable impact on the problem.  For example, a center may have as one focus fatal injury reduction and propose research, prevention/intervention, and translation projects that address this problem in a multidisciplinary manner with a goal of reducing fatalities in agriculture workers.

Two types of research, prevention/intervention, and education/translation projects may be included in the Agriculture Center, and both types are encouraged.  The two types are exploratory/short term projects (1 - 2 years, R21 type) and comprehensive projects (up to 5 years, R01 type).   Each project (exploratory and comprehensive) should be related to the overall goals established for the Center.  To be funded, an Agriculture Center must have one project, either exploratory or comprehensive, for each topic area (research, prevention/intervention, and translation) that is judged to have significant and substantial merit.  When appropriate, collaborative research is encouraged between Agriculture Centers and the NIOSH intramural program.

Exploratory research projects are intended to provide Agriculture Center investigators an opportunity to obtain the preliminary data needed for the submission of a NIOSH/CDC, NIH, EPA, or other peer-reviewed Project Grant application (R01 type).  The maximum project period for a exploratory project is 2 years.  Follow the instructions for a NIOSH Exploratory/Developmental (R21) grant (see NIH guide: http://grants.nih.gov/grants/guide/rfa-files/RFA-OH-00-006.html), for additional information on R21 applications).

Comprehensive research projects are intended to provide support for fully developed ideas that are ripe for study, and should be consistent with R01 projects that are typically awarded by NIOSH and NIH.  The project period for this type of project is usually three to five years. These projects will follow the submission guidelines for a R01 application according to the PHS 398 application instructions. See NIH guide: http://grants.nih.gov/grants/guide/pa-files/PA-99-143.html, for additional information on R01 applications.

RESEARCH PROJECTS
(SHOULD BE AT LEAST 30% OF THE ANNUAL DIRECT COSTS)

Research projects are hypothesis driven projects focused on improving our understanding of agriculture issues.  They may include, but are not limited to, projects involving surveillance, etiology, engineering, risk factor characterization, or development of analytical and exposure assessment approaches. They may be lab or field projects that provide the basis for creation or improvement of interventions.  Research projects should target priority topics, be done as a part of multidisciplinary efforts to address important problems, and avoid fragmentary efforts.  Other topics relevant to the agriculture environment are also appropriate.

PREVENTION/INTERVENTION PROJECTS
(SHOULD BE AT LEAST 20% OF THE ANNUAL DIRECT COSTS)

This section is for projects in prevention and/or intervention.  These studies are for testing promising approaches in actual agriculture settings.  Prevention/intervention projects may include but are not limited to actions taken to eliminate or reduce exposure to safety and health hazards via practices or policies, or projects to demonstrate the value of screening or related approaches to detecting disorders and diseases in early stages. They can also examine the value of larger preventive systems (e.g., the workers compensation system) in reducing hazards and adverse outcomes. Prevention/intervention projects examine the utility and impact of new and existing measures in the workplace.  They may include but are not limited to combinations of techniques such as control technologies, work practices, tools and materials, personal protective equipment, exposure guidelines and regulations, worker participation programs, contract language, design specifications, and changes in education and training.

Projects should address significant agriculture problems and involve agriculture stakeholder input to maximize relevance. The development of strong partnerships with organizations that can facilitate the identification of project needs and culturally appropriate, prevention, and intervention activities is encouraged. These projects should include the active participation of target populations identified at the state and national level, and include an evaluation plan to determine the efficiency and effectiveness of these techniques and programs. 

EDUCATION/TRANSLATION PROJECTS
(SHOULD BE AT LEAST 20% OF THE ANNUAL DIRECT COSTS)

These are projects that focus on the translation of extant knowledge (e.g. peer reviewed articles) into products or practices that meet agriculture “customer” needs so as to maximize the impact on industry practices.  The principal investigator (Center Director) should view these projects as the tool to move the results from the research environment into the agriculture industry.  As the goal for these projects is the adoption of new/improved knowledge in the agriculture sector, the principal investigator must include in the project plan how the study will accomplish this goal.

Education/Translation projects may include but are not limited to technology transfer projects or demonstration projects that expand the use of effective interventions by an agriculture trade or industry group.  Projects may address diffusion research issues to improve understanding of what influences agriculture industry decision-makers, workers, contractors, building owners, or others to adopt new practices, tools, and methods to improve safety and health performance.  Participatory research projects, where research subjects and researchers work as active co-partners on translation issues are encouraged.  Social marketing projects and other approaches that target important topics such as reducing agriculture fatalities at the industry, state, or national level are also appropriate.

Section II. Award Information

1. Mechanism(s) of Support

The administrative and funding instrument to be used for this program will be a cooperative agreement (U50), an "assistance" mechanism, in which substantial NIOSH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity.  Under the cooperative agreement, the NIOSH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role.  Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award."

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

The NIOSH U50 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the principal investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the principal investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

Approximately $7,500,000 is available to fund 7 to 9 awards.  The maximum amount that may be requested is $1,200,000 direct costs per year.  NIOSH will not accept applications requesting greater than $1.2 million in direct costs.  This level of expenditure is contingent upon the receipt of a sufficient number of applications directly relevant to the objectives of this PAR that are of high scientific quality as judged by a peer-review merit evaluation and the actual availability of funds.  

The total project period for an application submitted in response to this PAR may not exceed five (5) years.  The anticipated award date is July 1, 2006.  The award and level of support depends on receipt of applications of high scientific merit.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

Use of Funds

Applicants should allocate funds for travel for two project staff (the Agriculture Center Director and one other person) to attend annual meetings held during each project year.

Travel funds should also be planned for semi-annual meetings of Agriculture Center Directors as a Coordinating Committee (see Collaborative Responsibilities under Terms and Conditions of Award).  For planning purposes, assume that the meetings will be held in Washington, DC.

Applicants will be expected to establish an administrative core funded at the level of $200,000 of which $30,000 is for outreach, and $50,000 is for feasibility/pilot projects.

NON-ALLOWABLE COSTS FOR NIOSH AGRICULTURAL CENTER COOPERATIVE AGREEMENT

The Agriculture Center mechanism should not be used as a substitute for individual research grant support.  It is expected that investigators participating in Agriculture Centers will have a history of independent project support in addition to the Agriculture Center support.  Generally, funds for renovation of existing facilities or to purchase substantial amounts of equipment will not be allowed.  If such requests are made, they must be justified in terms of the critical nature of the equipment/renovations for the success of the overall objectives of the Agriculture Center Cooperative agreement.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIOSH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Foreign Institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing or Matching

Cost sharing or matching are not required.  However, there must be a demonstrated commitment of the applicant institution to the support and encouragement of the Agriculture Center.  Such support could be demonstrated by release time of faculty, capital improvements that will facilitate the research, and/or assistance in the acquisition of scientific equipment and supplies.  The applicant should include in the application a detailed description of the institutional support.  This information should be labeled “Institutional Support”.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Applicants must meet the eligibility criteria by the due date for submission.  Applications for renewal or supplementation of existing centers are eligible to compete   Applications must be responsive to the intent of the PAR.   NIOSH will not accept applications requesting greater than $1.2 million in direct costs.  

Section IV. Application and Submission Information

1. Address to 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.

Telecommunications for the hearing impaired: TTY 770-488-2783.

2. Content and Form of Application Submission

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.

All projects (research, prevention/intervention, or education/translation), should be consistent with the competitive/peer-reviewed applications that are typically awarded by NIOSH and NIH and adhere to the submission guidelines for  R21 and R01 applications following the PHS 398 application instructions.  The R21 is for projects that are exploratory and short-term in nature. R01 research projects are fully formed research efforts that are intended to produce definitive information and can last up to 5 years. 

PHS 398 form page 3 contains the section entitled “Research Plan” and although some projects are not hypothesis based research, this section should be used to describe the specific aims, background and significance, preliminary information or data, the project approach, for each project (research,  prevention/intervention, and education/translation).  This section should contain sufficient information to address the project’s goals and plan to achieve those goals, and should answer the following questions; 1) What do you intend to do?, 2) Why is the work important?, 3) What has already been done?, and 4) How are you going to do the work (see page 15 of the 398 instructions for additional guidance). 

Each project type section should begin with a cover sheet that identifies it as the beginning of the project section (administrative core, research, prevention/intervention, or education/translation), and the name of a project investigator who will be a member of the internal advisory committee should be listed.  This page is then followed by as many subsections as there are projects under that type.  Each subsection begins with a header page that identifies the project investigator and title of the project (do not use a 398 face page). The next page is the form page 2 of the PHS 398 which provides the description, performance sites, and key personnel.  For further instructions refer to the Table of Contents for a Agriculture Center Application, provided below.

For each comprehensive R01-type project, the application should not exceed 25 pages (see the Table of Contents for an Agriculture Center Application).  For exploratory  (R21-type) projects, follow the instructions for a NIOSH Exploratory/Developmental grant (R21), see NIH guide:  http://grants.nih.gov/grants/guide/pa-files/PA-04-030.html for additional information on R21 applications. A 15 page maximum should be followed. Refer to the Table of Contents for a Agriculture Center Application, provided below.  Each project should have its own detailed budget for year 01 and a detailed budget for the entire proposed period (PHS form 398- Pages 4 and 5)

The budget information, other support, etc. should be included in the appropriate sections of the application.  

NOTE:  NIOSH will inform successful applicants of the procedures for adding research, prevention/intervention, or education/translation projects in future years of support.  Thus, the application should contain only projects for which funds are requested for support during year one. In order to facilitate the preparation and review of the Agriculture Center application, the following Table of Contents should be used.  It is a minor modification of the 398 table of contents which should be followed as a guide.

TABLE OF CONTENTS FOR AN AGRICULTURE CENTER APPLICATION

Note: each project plan (research, prevention/intervention, and education/translation) should use the following outline:

 Agriculture Center (1 page maximum)
 Specific Aims
 Background and Significance
 Preliminary Studies/Progress Report
 Research Design and Methods

(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)

Human Subjects
Vertebrate Animals
Literature Cited
Consortium/Contractual Arrangements
Consultants and Collaborators, including NIOSH    

Note: Type density and size of the entire application must conform to the limits provided in the 398 instructions on page 6.

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.

Appendices are optional but allowed. Appendices should conform to the PHS398 Instructions.

3. Submission Dates and Times
See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): Annually on January 15   (Now October 30 each year per NOT-OH-06-007)
Application Receipt Dates: Annually on February 15   (Now November 30 each year per NOT-OH-06-007)
Peer Review Date(s):  February/March, each year
Council Review Date(s): May, each year
Earliest Anticipated Start Date: July 1, each year

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent is to be sent by express mail, delivery service, fax or email by the date listed at the beginning of this document.

The letter of intent should be sent to:

Charles Rafferty, Ph.D.
Assistant Director for Review and Policy
Office of Extramural Programs/NIOSH
Centers for Disease Control and Prevention
1600 Clifton Rd., NE, MS E-74
Atlanta GA 30333
Telephone: (404) 498-2582
FAX: (404) 498-2571
Email: cor9@cdc.gov 

3.B. Sending an Application

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).

Submit two additional copies of the application and all five sets of appendices to:

Charles Rafferty, Ph.D.
Assistant Director for Review and Policy
Office of Extramural Programs/NIOSH
Centers for Disease Control and Prevention
1600 Clifton Rd., NE, MS E-74
Atlanta GA 30333
Telephone: (404) 498-2582
FAX: (404) 498-2571
Email: cor9@cdc.gov

3.C. Application Processing

Applications must be received on or before the application receipt/submission 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.

The NIOSH and CSR will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIOSH and CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
 Executive Order 12372 does not apply to this program. This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIOSH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIOSH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIOSH approval before incurring the cost. NIOSH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIOSH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIOSH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission 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 who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, 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 any conditions will be placed 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). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. 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. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. 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

NIOSH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). 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 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.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to NIOSH for consideration.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by NIOSH in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The following will be considered in making funding decisions:

SITE VISITS

A site visit to the applicant institutions may be made (but such site visits are not assured) to evaluate the overall merit of the application. The site visit team would include members of the Special Emphasis Panel who have expertise in major research areas, facilities, and outreach activities of the proposed Center, the NIOSH Scientific Review Administrator, and NIOSH staff observer(s).

A site visit is not a prerequisite and is not assured for consideration of an application by NIOSH.  Therefore, the application is considered a complete document for review purposes.  Furthermore, the applicant should not use the site visit as an occasion for adding research projects, or investigators, for making major changes, or for delivering another exposition of the application.  Rather, it should be used by the 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 any component unit that is presented for evaluation at the site visit which has not been included in the application.  Budgetary changes also will not be considered at the time of a site visit.  The 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.

REVIEW CRITERIA FOR THE OVERALL PROGRAM:

The goals of NIOSH supported research are to advance our understanding of risks for biological systems, to improve the control of disease, and to enhance health. 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.

Significance: What is the potential impact of the Center in addressing regional and national health needs related to the etiology and prevention of disease and injuries of production agriculture/forestry/fishing agriculture? What is the potential of the outreach component to implement effective interventions and educate agricultural workers?

Progress: If this is a competing continuation application, or if this application builds on a preexisting NIOSH supported agricultural center, is there an adequate record of progress and accomplishments of the center?

Approach: Have the investigators adequately established the feasibility of meeting the proposed goals of the cooperative agreement program including a plausible schedule for initiating, accomplishing, and evaluating each of the activities of the cooperative agreement? Are the key stakeholders involved? Does the Program adequately address the distinct characteristics, specific populations, and needs in production agriculture/forestry/fishing? Is there an adequate plan for addressing the health issues of under-represented populations such as hired laborers, migrant/seasonal workers, women and children? Is the scope of the Center activities multidisciplinary? Are there appropriate administrative arrangements and facilities to stimulate collaboration among constituent projects and personnel? Are there adequate connections among the proposed research, intervention, and education projects, involving topical and collaborative relationships, to build a synergistic overall program?

Innovation: What is the degree of innovation of the Program? To what extent are novel administrative models, research methods, research topics, or potentially synergistic project relationships proposed that may enhance the potential of the Program to improve the health of agricultural workers.

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Are the core investigators adequately qualified to plan and conduct research and administer a national center for agricultural health and safety? Does the Center Director have adequate leadership ability, scientific stature, and commitment of time to adequately manage such a Center?

Environment: Does the scientific and institutional 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, or subject populations, or employ useful collaborative arrangements? Is there strong Institutional commitment to the proposed Center?

REVIEW CRITERIA FOR PROJECTS 

Significance: Does the study address an important occupational agricultural illness and injury problem? Have the broad, long-term objectives of the project and expected accomplishments been defined? If the aims of the application are achieved, how will scientific knowledge and clinical practice be advanced?  What will be the effect of this research on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?  

Approach: Are the conceptual 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 tactics? Is the time line proposed for the project suitable and realistic?  

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, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? 

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, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

REVIEW CRITERIA FOR ADMINISTRATIVE CORE

Adequacy of a Board of Advisors and Executive Committee: Are there appropriate plans for organizing and convening a Board of [external] Advisors to advise the Agricultural Center on the overall success of the work of the Agricultural Center. Are there appropriate plans for an Executive Committee drawn from internal faculty to advise and assist the Agricultural Center Director?

Adequacy of the Outreach Plan: Does the program adequately describe activities that will impact the practitioner, work environment, or other agencies and institutions located within the Agriculture Centers region?  Does the program facilitate the translation of occupational safety and health findings into the work environment?  Are appropriate occupational safety and health constituents engaged in the program?  Will the proposed activities have an impact on the practitioner or ability to affect occupational safety and health?

Adequacy of the Feasibility/Pilot Projects Program: Are the goals for the program well described?  Is the plan to conduct the Feasibility/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 encourage participation by other investigators interested in occupational safety and health either within the institution or regional institutions?  Is the plan for announcing the Feasibility/Pilot Projects Program funding adequate? Does the investigator provide a plan for retaining copies of all proposals, with documentation of their reviews, relative ranking, and final action?  Is there a mechanism for tracking the results of each Feasibility/Pilot Project study (abstract, RO1/R21 submission, dissertation, etc.)?

Adequacy of an Interdisciplinary Coordination Plan:  Does the applicant describe an appropriate plan for ensuring and enhancing interdisciplinary coordination among the research, intervention, and education projects?  Does the applicant provide evidence of past success in interdisciplinary coordination?

2.A. Additional Review Criteria:
 
In addition to the above criteria, the following items will continue to 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 Research Plan, Section E on Human Subjects in the PHS Form 398).

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 Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data 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. http://grants.nih.gov/grants/policy/data_sharing. NIOSH Program Staff will be responsible for the administrative review of the plan for sharing research data.  

2.D. Sharing Research Resources

NIOSH policy requires that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources 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. Program staff may negotiate modifications of the data and resource sharing plans with the grantee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIOSH will 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIOSH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the principal investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable 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, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U50), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIOSH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIOSH 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 NIOSH as defined above.

2.A.1. Principal Investigator Rights and Responsibilities

The principal investigator will have the primary responsibility for:                 

Coordinating the project activities, scientifically and administratively at the awardee institution and at the other sites that may be supported by sub-contractors to this award.  The principal investigator 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 cooperative agreement award.  The principal investigator  will:

2.A.2. CDC Responsibilities
 
A CDC project scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
Provide technical assistance through site visits and correspondence in the areas of program development, implementation, maintenance, and priority setting related to the cooperative agreement.

Provide scientific collaboration where needed.        

Assist in the reporting and dissemination of research results and relevant health and safety education and training information to appropriate Federal, State, local agencies, health-care providers, the scientific community, agricultural workers and their families, management and union representatives, and other CDC/NIOSH Centers for agricultural disease and injury research, education, and prevention.       

Assist in the development of human subjects protocols for the CDC Institutional Review Board (if required) and in the preparation of OMB (and other) clearances that may be required during the conduct of the study.

Additionally, a NIOSH program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

Coordinating Committee

Part of this initiative will be the establishment of a Coordinating Committee (CC) that will facilitate sharing of information about activities and accomplishments among the Centers.  This CC will also provide leadership and work collaboratively to address occupational safety and health issues at a national level such as combined Center efforts to reduce tractor-related injury and fatality.  The CC will be comprised of the principle investigators from the Centers.  NIOSH representatives will participate in CC meetings where appropriate but will not have voting privileges.  Each full member will have one vote. Grantee members of the Coordinating Committee will be required to accept and implement policies approved by the Coordinating Committee.

Function of Coordinating Committee

It is anticipated that critical issues for understanding and protecting agricultural workers from job risks will be better defined through the deliberations of the CC.  The CC will combine the expertise and resources of the Centers with those of NIOSH to achieve a more integrated and effective program in agricultural health and safety. The emphasis of the Agriculture Centers should be on addressing priority, regional (multi-state) occupational health and safety problems using a multi-disciplinary approach.   Emphasis should also be given to populations not well represented in the current research such as hired farm laborers, migrant/seasonal workers, foresters, fisherman, women and children.

The CC may designate working groups for specific purposes, made up of staff members from their Centers.  One such working group would be an Agriculture Centers Methods Committee.  This multisite committee will provide a means to standardize the collection of evaluation materials/information across Agriculture Centers.  It will also provide a means to collect information necessary to help address accomplishments on the NIOSH Agricultural Initiative.  Information and materials may be collected at one repository location for common use by all Centers.  If there are added costs associated with creating and maintaining this repository, NIOSH may determine that a contract or other mechanism could be used to fund it.

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

3. Reporting

Comprehensive Annual Center Report.  In addition to the summary progress report required for continuation applications, the Center Director prepares and submits separately, within 30 days following the conclusion of each budget period, a comprehensive annual report of all activities relating to the Center. This report is submitted electronically. Typically, this report includes:

(a) An "Introduction and Summary" of the program.

(b) Directors report on major accomplishments (highlights).

(c) Detailed progress reports on each project, grouped according to type with appropriate references and a list of publications since the last annual report.

(d) A progress report on feasibility/pilot projects.

(e) A report on the Outreach Program.

(f) A report on specific improvements in agriculture safety and health that resulted from center activities.

(g) An administrative report, discussing relevant personnel and other matters.

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Lee Husting, Ph.D.
Scientific Program Administrator
Office of Extramural Programs/NIOSH
Centers for Disease Control and Prevention
1600 Clifton Rd., NE, MS E-74
Atlanta GA 30333
Telephone: (404) 498-2506
FAX: (404) 498-2571
Email: eih8@cdc.gov 

2. Peer Review Contacts:
  
Charles Rafferty, Ph.D.
Assistant Director for Review and Policy
Office of Extramural Programs/NIOSH
Centers for Disease Control and Prevention
1600 Clifton Rd., NE, MS E-74
Atlanta GA 30333
Telephone: (404) 498-2582
FAX: (404) 498-2571
Email: cor9@cdc.gov 


3. Financial or Grants Management Contacts:

Cynthia Mitchell
Grants Management Branch, Procurement and Grants Office
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Telephone: (412) 386-6434
FAX: (412) 386-6459
Email: cmitchell@cdc.gov

4. General Questions Contacts:

Technical Information Management Section
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA  30341
Telephone: 770-488-2700
Email: PGOTIM@cdc.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with 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.

Human Subjects Protection:
Federal regulations (45CFR46) 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).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIOSH that women and members of minority groups and their sub-populations must be included in all NIOSH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIOSH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIOSH policy requires education on the protection of human subject participants for all investigators submitting NIOSH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIOSH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 PA is related to the Occupational Safety and Health Goal “Promote the health and safety of people at work through prevention and intervention” in the numbered objective series 20-1 through 20-11.  This series includes several priority areas, including 20-1e to “Reduce deaths from work- related injuries” in Agriculture, forestry, and fishing; 20-2d “Reduce work-related injuries resulting in medical treatment, lost time from work, or restricted work activity” in Agriculture, forestry, and fishing.  Other work-related exposures important in agriculture such as noise induced-hearing loss, and conditions such as occupational skin diseases are included in the series.

Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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 NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Lobbying Restrictions:
Applicants should be aware of restrictions on the use of Health and Human Services (DHHS) 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 the Center for Disease Control and Prevention (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, 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 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 healthy environments.

Recipients of 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, publication, and “grassroots” activities that relate to specific legislation, recipients of CDC funds should give attention to isolating and separating the appropriate use of CDC funds from non-CDC funds.  CDC also cautions recipients of CDC funds to be careful not to give the appearance that CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.


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