Part I Overview Information

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Department of Health and Human Services

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

Components of Participating Organizations

National Institute for Occupational Safety and Health (NIOSH), (http://www.cdc.gov/niosh)

Title: Centers for Agricultural Disease and Injury Research, Education, and Prevention (U54)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement may differ from those used by the HHS National Institutes of Health (NIH). Written guidance on completing an application is provided in this announcement and at various websites referenced herein.

Authority

This program is described in the Catalog of Federal Domestic Assistance and is not subject to 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 Parts 52 and 86 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
This Funding Opportunity Announcement (FOA) is a reissue of PAR-06-057.

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

• September 22, 2015 - This PAR has been reissued as PAR-15-353.
• November 21, 2012 - See Notice NOT-OH-12-005. Notice of Change to Expiration Date.
• October 21, 2011 - See Notice NOT-OH-11-005. NIOSH is announcing that new or revised Ag Center applications will not be accepted for the December 2, 2011 receipt date.
• December 22, 2010 - See Notice NOT-OH-11-002 This Notice updates various sections of this PAR.

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). NIOSH is following the NIH transition schedule.

Program Announcement (PA) Number: PAR-11-022

Catalog of Federal Domestic Assistance Number(s)
93.262

Key Dates
Release Date: November 5, 2010
Letter of Intent Receipt Date(s): January 4, 2011; November 2, 2011; November 4, 2012.
Application Receipt Dates(s): February 4, 2011; December 2, 2011 (Not accepting applications per NOT-OH-11-005); (Not accepting applications per NOT-OH-12-005 December 4, 2012), (New Date December 2, 2013 per NOT-OH-12-005).
Peer Review Date(s): April 2011; February/March 2012; February/March 2013.
Council Review Date(s): May 2011; May 2012; May 2013.
Earliest Anticipated Start Date: July 1, 2011; July 1, 2012; July 1, 2013.
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date: (Extended to December 3, 2013 per NOT-OH-12-005), Originally December 5, 2012.

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• Purpose. NIOSH is encouraging applications from qualified organizations for Centers of Excellence in Agricultural Disease and Injury Research, Education, and Prevention (Ag Centers). These centers will conduct high quality research and help translate scientific discoveries into practical applications to improve worker safety and health. Ag Centers are expected to have a high caliber of scientific and technical competency, be forward looking, and provide regional leadership in the development and delivery of relevant interventions to improve Ag health and safety. Center structure should take advantage of diverse scientific resources and focus on local, regional and national issues. Center functions should include developing holistic approaches that link prevention, intervention, translation, outreach, education, and evaluation. The implementation of innovative, evidence-based solutions that address important agricultural safety and health problems in a collaborative manner is expected. While a specific Center theme is not required, applicants must concisely describe the mission, structure, function and service area of the proposed Center. Supporting information on major issues, priority focus areas, and essential gaps/needs must be concise, complete, timely and clearly tied to the basis for the proposed Center.
• Mechanism of Support. This FOA will utilize the U54 cooperative agreement mechanism.
• Funds Available and Anticipated Number of Awards. About $12M per year is available to be awarded under the Ag Center program. This includes new applications and resubmission applications. In FY-2011, it is anticipated that 7-9 center awards will be made for up to 5 years. Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.
• Budget and Project Period. Applicants may request a project period of up to five years and an annual budget for direct costs up to $1.3 million dollars per year.
• Application Research Strategy Length: The Research Strategy page length varies by the type of project. Page limits are clearly specified in Section IV. Application and Submission Information of this announcement.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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 NIOSH support.
• Number of PDs/PIs. More than one PD/PI or multiple PDs/PIs may be designated on the application as Center director. In this case, each PD/PI will be considered a Center co-director. Multiple PIs may also lead individual research, prevention, intervention, translation, outreach, education or evaluation projects. Multiple program directors may also be designated.
• Number of Applications. Eligible applicant institutions may submit one application to this announcement.
• Resubmissions. Applicants may submit one resubmission application which must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIOSH poloicy on resubmission (amended) applications (NOT-OH-10-008).
• Renewals. Applicants may submit a renewal application.
• Special Date(s). This FOA uses non-standard receipt dates.
• Application Materials. See Section IV.1 for application materials.
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (770) 488-2783.

Table of Contents

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Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section 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. 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. Submitting an Application to NIOSH
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
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. NIH Responsibilities
3. Collaborative Responsibilities
4. Dispute Resolution Process
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

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Section I. Funding Opportunity Description

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1. Research Objectives

Background

A three year policy development process (1987-1990) known as Agricultural Occupational and Environmental Health: Policy Strategies for the Future resulted in the emergence of occupational health and safety in US agriculture as a public health policy issue (see Agricultural at Risk: A Report to the Nation). Agricultural health and safety programs which subsequently resulted include NIOSH agricultural occupational health programs, The Kellogg Foundation agricultural health grants programs, and prospective chronic health studies of pesticides funded by USEPA and NIH.

In 1990, Public Law 101-517 directed NIOSH to establish a program of improving the health and safety of agricultural workers and their families. Details in the Senate appropriations language of PL 101-517 included the innovative call to establish extramural Centers for Agricultural Disease and Injury Research, Education, and Prevention (Ag Centers). Beginning in 1990 NIOSH established and maintained these centers through a series of competitive funding opportunity announcements (FOAs) including PAR-06-057, RFA-OH-03-002, and RFA-OH-01-004.

The Ag Centers conduct high quality research and help translate scientific discoveries into practical applications to improve agricultural health and safety. These centers of excellence help find practical solutions to complex problems, cultivate collaboration and partnerships, and conduct outreach/education efforts for specific issues or worker populations. The Ag Centers are distributed throughout the nation to be responsive to agricultural safety and health issues unique to different regions. Links to the Ag Centers currently funded by NIOSH are provided below:

Great Plains Center for Agricultural Health
High Plains Intermountain Center for Agricultural Health and Safety
Northeast Center for Agricultural and Occupational Health
Pacific Northwest Agricultural Safety and Health Center
Southeast Center for Agricultural Health and Injury Prevention
Southwest Center for Agricultural Health, Injury Prevention, and Education
Western Center for Agricultural Health and Safety

Highlights of recent activities can be found in the Spring 2010, Summer 2010 and Fall 2010 editions of the Ag Connections newsletter. Earlier editions of Ag Connections are also available online.

Note: NIOSH also funds the National Children’s Center for Rural and Agricultural Health and Safety (Child Ag Center). This center strives to enhance the health and safety of children exposed to hazards associated with agricultural work and rural environments. The center recompeted for funding in 2008.

From mid-2005 through 2008, the National Academies (NA) conducted separate evaluation studies of eight NIOSH programs, including Agriculture, Forestry and Fishing. These evaluations were guided by a framework document which set standards and methods for all the reviews. Prior to the evaluation, NIOSH provided an initial report to the NA evaluation committee. Upon completion of the evaluation, the NA found the Ag Centers to be a national resource for addressing occupational safety and health problems through research, education, prevention and intervention. The committee considered the centers to be an invaluable component of NIOSH s efforts to improve agricultural safety and health.

As the NA reviews were occurring, NIOSH entered the second decade of the National Occupational Research Agenda (NORA) with a sector and cross-sector based structure to better move research to practice within workplaces. The transition to the new NORA structure involved developing a NORA National Agriculture, Forestry, and Fishing Agenda. In addition, NIOSH has prepared a draft plan to implement recommendations made by the NA evaluation committee.

Continued Need for Efforts in Agricultural Health and Safety

Agriculture, forestry and fishing continue to rank among the most hazardous industries in the US. National Census of Fatal Occupational Injuries (CFOI) data for 2005-2009 indicate that overall fatality rates for workers in agriculture (farming, ranching, forestry, logging and fishing) continue to be at least 6-10 times greater than U.S. workers in general. Fatality rates for parts of the sector (commercial fishing, logging) are often much higher (up to 50 times greater than U.S. workers in general). Overall fatality rates in agriculture typically exceed those for occupations traditionally known as dangerous, such as mining and construction.

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

Information compiled by NIOSH from various sources indicates that in the United States:

• About 1.82 million full-time workers were employed in production agriculture in 2008. That year 456 farmers and farm workers died from work-related injuries yielding a fatality rate of 25.1 deaths per 100,000 workers.
  
  
• From 1992-2007, almost 8,100 farmers or farm workers died from work-related injuries. The leading cause, tractor overturns, killed 96 people per year on average.
  
  
• Each day about 243 agricultural workers suffer lost-work-time injuries. Five percent of these result in permanent impairment.
  
  
• About 1.12 million children and adolescents under 20 years of age resided on farms in 2006. About 590,000 of these youth worked on the farms and an additional 307,000 children and adolescents were hired to work on farms. An estimated 23,100 children and adolescents were injured on farms; 5,800 of these injuries were due to farm work.
  
  
• The most effective way to prevent tractor overturn deaths is the use of a Roll-Over Protective Structure (ROPS) combined with use of a seatbelt. In 2006, only 59% of tractors used on farms were equipped with ROPS. If ROPS were placed on all current farm tractors manufactured since the mid-1960s, the prevalence of ROPS-equipped tractors could be increased to over 80%.

Commercial fishing is part of the Agriculture, Forestry and Fishing industry sector. Between 80,000-160,000 fishermen are employed on about 80,000 fishing vessels in the US. This industry consistently experiences one of the highest occupational fatality rates in the country. In 2007, commercial fishermen had the most dangerous job in the United States, with an annual fatality rate 28 times greater than the rate of all U.S. workers (112 and 4 per 100,000, respectively). A review of commercial fishing fatalities conducted by the U.S. Coast Guard (USCG) found that during 1994-2004:

• 641 commercial fishermen died while fishing in the US;
• More than 100 vessels were lost each year and resulted in more than half of all fatalities;
• Another 184 (29%) fatalities were due to fisherman falling overboard;
• Additional fatalities were due to deck injuries (8%), diving (5%) and fires or explosions (5%).

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

Priorities

The NORA Agricultural, Forestry, and Fishing Sector Council has developed strategic goals related to:

• Improving surveillance to describe the nature, extent, and economic burden of occupational illnesses, injuries, and fatalities; occupational hazards; and worker populations at risk for adverse health outcomes;
  
  
• Reducing deleterious health and safety outcomes for workers who are more susceptible to injury or illness due to circumstances which limit options for safeguarding their own safety and health;
  
  
• Moving proven health and safety strategies into workplaces through partnerships and collaborative efforts;
  
  
• Reducing the number, rate, and severity of traumatic injuries and deaths involving hazards of production agriculture, commercial forestry and commercial fishing; and
  
  
• Improving the health and well-being of workers throughout this sector by reducing occupational causes of, or factors contributing to, acute and chronic illness and disease.

Additional details on the strategic goals can be obtained from the NORA National Agriculture, Forestry, and Fishing Agenda. (Note: Appendix II provides a dictionary to help standardize terminology used to describe and report occupational hazards, risks, injury, disease and illness).

Top priorities identified in the NORA National Agriculture, Forestry, and Fishing Agenda include:

• Improved systems for collecting, analyzing and reporting data (surveillance);
• Valid, timely data regarding characteristics of vulnerable workers;
• Evidence-based interventions for vulnerable workers;
• Effective interventions in preventing tractor rollovers and runovers;
• Effective interventions to reduce the incidence and prevalence of musculoskeletal disorders; and
• Effective interventions to reduce deaths associated with vessel sinking and falls overboard.

The 17 priorities identified in the previous Ag Center announcement (PAR-06-057) are still considered to be important.

Interested applicants are encouraged to consult Agriculture, Forestry and Fishing Research at NIOSH published by the National Research Council and Institute of Medicine. Chapter 11 discusses new and emerging research areas, and specifically identifies the following six high priority research areas:

• Changes in demographic characteristics of the workforce;
• Changes in the fishing industry;
• Emerging forestry issues;
• Blurring boundaries for food harvesting and food processing;
• Food safety and security; and
• Industrialization of agriculture.

Chapter 12 of Agriculture, Forestry and Fishing Research at NIOSH lists eight major recommendations related to improving the NIOSH Agriculture, Forestry and Fishing Research Program. Topics related to Ag Centers include:

• Aligning efforts with national goals and addressing issues on a regional scale;
• Addressing regional forestry and fishing-related issues where applicable;
• Enhancing the use/role of the National Agricultural Safety Database (NASD);
• Conducting research on knowledge diffusion processes;
• Conducting research on reproductive health related to workers; and
• Partnering with state, regional, local, community agencies to increase the capacity for transforming research findings into practical, sustainable solutions.

Tractors

Deaths and injuries from tractors continue to be a great concern in the US. There are ample research data that identify tractor rollovers as the most frequent cause of death in the agricultural community. The most effective way to prevent tractor overturn deaths is the use of a Roll-Over Protective Structure (ROPS) in conjunction with a seatbelt. It is also important to keep kids away from tractors.

Additional information on ROPS can be found in the January 2010 issue of the Journal of Agricultural Safety and Health. This includes the following:

• 2010 Jan;16(1):3-4 (PubMed PMID: 20222266)
• 2010 Jan;16(1):5-18 (PubMed PMID: 20222267)
• 2010 Jan;16(1):31-40 (PubMed PMID: 20222269)

Websites with pertinent tractor-related information include:

• http://depts.washington.edu/trsafety/
• http://www.mc.uky.edu/SCAHIP/nationaltractorsafetyinitiativedesingningcommunity.html
• http://www.ecu.edu/cs-dhs/agromedicine/tractor.cfm
• http://agcenter.ucdavis.edu/tsi/tractor_safety.php
• ROPS Guide

Challenges for Ag Centers

The diverse occupational environments found in this sector reflect the many types of activities conducted in production agriculture, commercial forestry and commercial fishing. These activities can vary substantially by geographic region, time of year and the state of the economy in the US or other countries.

For these, and other, reasons, Ag Centers face a variety of challenges that include:

• Identifying critical regional issues (or needs) and developing holistic approaches toward resolving those issues or meeting those needs in alignment with national goals.
  
  
• Linking and integrating evidence-based prevention, intervention, translation, outreach, education, and evaluation in innovative ways.
  
  
• Maintaining a high caliber of scientific and technical competency.
  
  
• Being forward-looking and functioning effectively beyond multiple individual projects.
  
  
• Building an operational base that extends beyond NIOSH funding.
  
  
• Developing and sustaining collaborative, systematic approaches to identify new knowledge and use it to improve agricultural safety and health.
  
  
• Effectively using evaluation to help assess impact, guide projects and assess programs.

To help meet these challenges and achieve maximum effectiveness, Ag Centers often rely on collaborative, sustainable partnerships with diverse organizations. This includes service oriented groups (Agrisafe, NECAS, Agriwellness), state-funded centers (I-CASH, NYCAMH) or programs (Certified Safe Farms), state/federal agencies (USDA NASS and NIFA), professional organizations (NIFS), private insurance companies (Farm Bureau) and other groups (AEM, ASHCA). State, regional, local, or community health departments can also provide effective partnerships to help initiate, promote and sustain a variety of activities related to agricultural health and safety.

Ag Centers are considered to be centers of excellence and are expected to be cohesive, coordinated and synergistic in their efforts to improve agricultural health and safety. A particular challenge is developing a cohesive center built on individual projects/programs that are scientifically and technically meritorious, and clearly contribute in an integrated manner to the overall Center mission. Thus, each part must be sound, and the combined parts together must represent a coordinated, cohesive effort toward developing and delivering relevant interventions to improve agricultural health and safety.

Impact

Centers are expected to exert a sustained, powerful (transformative) influence on agricultural health and safety (including forestry and fishing). The focus of each center may vary based on regional needs and priorities. Overall, the research, prevention, intervention, outreach, education, translation and evaluation efforts of all centers should be focused on improving worker health and safety. All levels of Center efforts are expected to have a direct tie to impacts whenever possible. NIOSH strongly encourages the use of suitable evaluation techniques/tools and follow-up actions to help assess impact and outcomes.

Institutional Commitment

NIOSH intends to continue the Ag Center program and would like to receive cooperative agreement applications which address regional and national needs in agricultural health and safety. Applicants should provide holistic approaches that link and integrate evidence-based prevention, intervention, translation, outreach, education, and evaluation in innovative ways. Centers are expected to have a high caliber of scientific and technical competency, be forward looking, and provide regional leadership in the development and delivery of relevant interventions to improve Ag health and safety.

Applicant institutions must demonstrate a commitment of support and encouragement for an Ag Center. Examples include faculty release time, acquisition of scientific equipment and supplies, capital improvements for program facilities, travel and meeting/conference support. Helping ensure that an Ag Center has full support of, and access to, the diverse resources available at the institution is critical in synergizing the efforts, impacts and outcomes of NIOSH funding.

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

Section II. Award Information

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1. Mechanism of Support

This funding opportunity announcement (FOA) will use the U54 cooperative agreement award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

This is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIOSH 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".

This is an ongoing program. Applications to this announcement may include a project period of up to five years. NIOSH intends to re-announce the program upon expiration of this announcement.

2. Funds Available

NIOSH intends to commit about $12 million in FY2011 to fund 7-9 cooperative agreements in response to this FOA for a period of up to 5 years. Funding amounts in future years will depend on annual NIOSH appropriations.

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.

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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 the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Section III. Eligibility Information

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1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public nonprofit organizations
• Private nonprofit organizations
• For profit organizations
• Small, minority, and women-owned businesses
• Universities
• Colleges
• Research institutions
• Community-based organizations
• Faith-based organizations
• Federally recognized or state-recognized American Indian/Alaska Native tribal governments
• American Indian/Alaska Native tribally designated organizations

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 his/her 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 CDC programs.

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

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

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Eligible applicant institutions may submit one application to this announcement.

Resubmissions. Per NIOSH policy, one resubmission application is allowed provided that it includes an Introduction which addresses the previous peer review critique (Summary Statement).

Renewals. Applicants may submit a renewal application.

Section IV. Application and Submission Information

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1. Address to Request Application Information

Current 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) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Prepare all applications using PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

Information in the remainder of this section describes special requirements, specific content to be included, items to be addressed, and guidance on how to organize an application.

ESSENTIAL AG CENTER COMPONENTS

Ag Center cooperative agreements will support broadly based multi-disciplinary research, prevention, intervention, translation, outreach, education and evaluation programs. Ag Centers are expected to have the following components that cohesively address the stated goals, objectives, and service/focus areas of the Center:

• Administrative and Planning Core (up to $140K direct costs)
  
  
• Pilot/Feasibility Projects and Emerging Issues Program (up to $70K direct costs)
  
  
• Outreach Program (up to $40K direct costs)
  
  
• Research Core Projects (about 30% of annual costs)
  
  
• Prevention/Intervention Core Projects (about 20% of annual costs)
  
  
• Education/Translation Core Projects (about 20% of annual costs)
  
  
• Evaluation Program (about 10% of annual costs)

The percentages provided above are guidelines and projects may overlap the categories. The combination of projects and level of effort in each category will depend on how a Center identifies: 1) its service area, 2) the critical needs and gaps to be addressed, 3) the role(s) of the Center, and 4) the systematic approaches that the Center will use to achieve a measurable impact on agricultural safety and health.

While a specific Center theme is not required, applicants must concisely describe the mission, structure, function and service area of the proposed Center. Supporting information on major issues, priority focus areas, and essential gaps/needs must be concise, complete, timely and clearly tied to the basis for the proposed Center. The overall Center effort must represent a reasonable, prudent, forward-looking, innovative, and cost-effective approach toward meaningful and measurable impacts.

Administrative and Planning (AP) Core

The AP Core facilitates the leadership, guidance, and management of the Center Director in accomplishing the stated objectives the Ag Center. It provides the infrastructure to promote cross-discipline interactions among all cores, programs and projects, and to help ensure research translation.

The structure of the AP Core provides the Center Director with a mechanism for:

• planning, coordinating and monitoring research, prevention, intervention, education, translation, outreach, education, and evaluation efforts;
• integrating cross-discipline expertise;
• overseeing fiscal and resource management;
• managing internal and external advisory committees;
• ensuring appropriate facilities for seminars, meetings, workshops, advisory committee meetings or conferences;
• managing records; and
• compiling annual report information.

Applicants must clearly explain how the AP Core will achieve effective and efficient administrative functions. Clear lines of communication and mechanisms for ensuring integration and interaction between projects, including evaluation, are expected.

Center Directors should provide at least a 15% time commitment (direct and in-kind). The AP Core supports the entire Center and should not be duplicated within other components.

Internal and External Advisory Committees

To aid the Center Director in achieving the goals of the Ag Center, the establishment of Internal and External Advisory Committees is required.

Internal Advisory Committees assist Center Directors with scientific and administrative decisions about operations of the Ag Center. These committees should be comprised of individual project/program leaders. At least one from each type of project (research, prevention, intervention and translation) should be included. Senior key personnel responsible for the Pilot/Feasibility Projects and Emerging Issues Program, the Outreach Program and the Evaluation Program should also be included. Responsibilities include monitoring progress, integrating cross-discipline expertise, providing advice on outreach, evaluation, and translation, and resolving problems.

External Advisory Committees provide guidance, advice and feedback to Center Directors, project/program leaders, key center personnel, and project scientists on the progress, direction, impact, and effectiveness of the Center. These committees should include people knowledgeable about agriculture health and safety in the area or region served by the Ag Center. Committee composition should represent the diversity of production agriculture, commercial forestry or commercial fishing activities in 1) area or region served by the Ag Center, 2) the projects being undertaken by the Center, and 3) the goals of the Center. Members could include regional or national agriculture experts, producers, farmers, ranchers, workers, extension specialists, insurers, equipment dealers or manufacturers, healthcare providers, community organizations, or a NIOSH scientist (as a non-voting member).

Annual meetings to review the Ag Center’s progress, direction, successes, impacts and challenges should be convened. These meetings should provide an open exchange of ideas, information, approaches and knowledge on various topics including: effective research translation; linking researchers and stakeholders; identifying effective outreach and education activities; emerging issues; coordinating research across disciplines; and sustainability of established, effective prevention, intervention, outreach and education efforts. Effective external advisors can serve as force multipliers to enhance Center effectiveness, expand Center reach, and increase the sustainability of Center efforts beyond reliance on NIOSH funding alone.

Pilot/Feasibility Projects and Emerging Issues Program (up to $70K direct costs)

Pilot/Feasibility projects are fundamental to sustaining the quality, breadth and dynamics of an Ag Center program the program. These projects are expected to lead to the development of new and creative research, prevention, intervention, outreach, education, evaluation or translation findings and outcomes. They should develop and explore new activities or directions, or take advantage of special opportunities. Pilot projects may not be used to supplement or prolong ongoing research and should not be used as bridge funds when other research support is no longer available.

Funds should be designated to provide support for short-term projects (12-18 months and up to $25K per project). This will also enable investigators to collect sufficient data to pursue support through other funding mechanisms. A few examples of feasibility or pilot projects include:

• Initial support for developing novel, innovative, cutting edge research, translation, prevention, intervention, education or outreach approaches;
• Adapting and evaluating proven prevention, intervention, outreach or education tools or techniques for new populations, work environments or delivery systems;
• Obtaining preliminary data, mining existing state or national datasets or pursuing critical data gaps;
• Supporting investigators from other fields of study to apply their expertise to agriculture safety and health challenges;
• Developing new mechanisms for external or multi-Center collaborative partnerships to address emerging agriculture safety and health concerns; and
• Exploring new directions that represent significant departures from established approaches yet have the potential to yield great impacts.

Input from Internal and External Advisory Committees on managing the Pilot/Feasibility Projects and Emerging Issues Program is strongly recommended. Committee members can advise on scientific merit, relevance and importance, cross discipline integration, linkage or access to viable stakeholders, likelihood of success, and important factors for outreach or education activities.

The Center application must clearly address how the following will be accomplished:

• Widely announcing each pilot/feasibility project funding opportunity;
• Conducting a merit review of pilot/feasibility project proposals;
• Maintaining appropriate records including copies of proposals and their reviews, relative rankings, and final actions (upon request, these records must be made available to the NIOSH Scientific Program Official named in the notice of grant award);
• Ensuring that appropriate human subjects protections are provided;
• Reporting results or outcomes for each pilot/feasibility project study (publications, presentations, independent grant applications, guidance documents, web sites, etc.) in grant progress reports or annual reports; and
• Sharing significant results or outcomes to the NIOSH Scientific Program Official named in the notice of grant award in a timely manner.

Center applications should focus on how this program will be structured and managed. Brief highlights, progress statements or outcomes of previous pilot or feasibility studies may be included. Areas of interest or priorities for future projects may be included if known.

Note on Emerging Issues. It is not always possible to predict: what, when or where new issues may emerge; when a rapid response by a Center could be critically important; or when a small, timely investment by a Center could make a big difference. To help address these situations, Center Directors are allowed some latitude to use $5-10K from this program for strictly extramural activities at their discretion. The Center Director must fully report the discretionary use of these funds, including the rationale and outcome of the Center’s efforts, to the NIOSH Scientific Program Official named in the Notice of Grant Award. Any such discretionary use of these funds must fully comply with all applicable HHS/CDC/NIOSH policies.

Outreach Program (up to $50K direct costs)

Effective outreach is necessary to ensure that evidence-based prevention or intervention findings, best practices, tools, approaches, technologies, guidelines or policies reach the workplaces and the people who can benefit from them. Ag Centers must have external partnerships and collaborations to accomplish this.

Applicants should highlight strategies and collaborations that can yield effective adoption of best practices in production agriculture, commercial forestry or commercial fishing at regional or national levels. Best practices could include new technologies, engineering controls, behavior change interventions, education, training, guidelines or incentive programs.

Cross-center coordination is strongly encouraged to help provide an economy of effort, cost savings, and to maximally extend any given outreach effort. This could also include ongoing agriculture communication efforts, regional center meetings or joint center meetings based on common interests, issues, problems or projects.

Ag Centers should have a cohesive plan for timely dissemination and translation of evidence-based techniques, tools or programs. Appropriate communication interventions should be used to promote the adoption of evidence-based health protection or injury prevention practices. Strategic partnerships and collaborations should be established to diffuse evidenced-based practices for preventing work-related illness, injury, and death into the workplace. Outreach activities and materials should be culturally, linguistically and educationally appropriate.

Research Core Projects (about 30% of annual costs)

Research projects are hypothesis driven projects focused on improving our understanding of agricultural health and safety 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 laboratory 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. Topics should be relevant at the regional or national level.

Prevention/Intervention Core Projects (about 20% of annual costs)

These studies are for testing promising approaches in actual agriculture, forestry or fishing 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.

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

Education/Translation Core Projects (about 20% of annual 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 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 or 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.

Evaluation Program (about 10% of annual costs)

Effective, consistent, realistic and convincing evaluation is essential for both short- and long-term progress toward improving agricultural safety and health. The NIOSH Ag, Forestry and Fishing Program had major evaluations in 1995 ( the Kennedy Report ) and 2007 ( the National Academies report ). Evaluation challenges of Ag Centers were discussed by McDonald and White in 1998. Donham and Storm also discussed evaluation in their 2002 paper. In an effort to enhance and improve Ag Center evaluation activities, NIOSH has also funded the Ag Center Evaluation Project.

Ag Center applications must incorporate appropriate evaluation activities at the program, project or overall center level. Center Directors are allowed flexibility in developing sensible, practical and realistic Evaluation Programs. Approaches and rationales should be clearly explained in relevant sections of the application. Centers may balance evaluation costs between this component, individual projects and other Center programs or cores (as appropriate) to help achieve an economy of effort, cost savings, or to gain maximum benefits from any given evaluation effort.

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

The 2^nd edition (2004) of The Handbook of Practical Program Evaluation (Wholey, Hatry and Newcomer) provides a comprehensive evaluation reference. Applicants may also find the following links helpful:

• Centers for Disease Control and Prevention. Framework for Program Evaluation in Public Health. MMWR 1999;48 (No. RR-11).
• Framework for Program Evaluation in Public Health
• Evaluating Occupational Health and Safety Research Programs

Types of Projects

Several types of research, prevention, intervention, education, translation or evaluation projects are encouraged:

• comprehensive projects (R01);
• small projects (R03);
• exploratory or developmental projects (R21); and
• translation projects (R18).

Regardless of the types of projects proposed, they must be clearly tied to the goals, aims and mission of the proposed center.

Comprehensive projects (R01) address fully developed ideas and represent fully formed research efforts that are intended to produce definitive information. The project period is expected to be 3-5 years. Additional information on the R01 funding mechanism is available at: http://grants1.nih.gov/grants/guide/pa-files/PAR-10-188.html and http://grants.nih.gov/grants/guide/pa-files/PAR-09-138.html.

Small projects (R03) can be carried out in a short period of time (1-2 years) with limited resources (typically up to $50K direct costs/year for up to two years). Examples include pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. Additional information on the R03 funding mechanism is available at the following web sites: http://grants.nih.gov/grants/guide/pa-files/PAR-09-138.html and http://grants.nih.gov/grants/guide/pa-files/PA-10-064.html.

Exploratory/developmental projects (R21) are intended to support early and conceptual stages of project development. This can include novel projects that break new ground or extend previous discoveries toward new directions or applications. High-risk/high-reward studies that may lead to breakthroughs in specific areas, or result in novel techniques, methodologies, models or applications may be considered. These types of projects often generate preliminary data that supports submission of more comprehensive research, prevention, intervention, education, translation or evaluation grant applications. The project period for R21-type proposals is expected to be up to 2 years. Additional information on the R21 funding mechanism is available at: http://grants.nih.gov/grants/guide/pa-files/PAR-09-138.html and http://grants.nih.gov/grants/guide/pa-files/PA-10-069.html.

Relevant, high quality research findings alone do not assure good agricultural safety and health practices under real world conditions. Acceptance and effective transfer or incorporation of such findings into routine safety and health practices, guidelines or policies is not automatic. Translation projects (R18) are intended to support efforts to facilitate the transfer of research findings to practice through implementation, dissemination and diffusion research. Proposals should identify 1) impediments/facilitators to the successful translation of evidence-based agricultural safety and health interventions; 2) methods for the successful translation of evidence-based interventions that retain fidelity, and achieve positive outcomes for specific populations; or 3) optimal strategies to enhance the widespread adoption and institutionalization of effective safety and health intervention programs. Types of interventions may include, but are not limited to, educational strategies, community-based approaches, behavior change techniques, demonstration and dissemination projects, and environmental or organizational strategies. The project period for R18-type proposals is expected to be 2-4 years. Prospective applicants can refer to the NIOSH Research to Practice (r2p) program. R2p is focused on transferring and translating knowledge, interventions, and technologies into highly effective prevention practices or products which are adopted in the workplace. Additional information on a variety of translation research is available at Improving Public Health Practice through Translation Research, Research Demonstration and Dissemination Grants, and Transforming Primary Care Practice.

Tractor-related Projects

Tractor-related proposals included as part of an Ag Center application must clearly and concisely identify the nature and scope of the problem to be addressed, the approach to be used and how the project would contribute to a national solution.

Tractor-related proposals for engineering approaches (e.g., sensors for rear overturn prevention and side stability information, operator control designs, engineering plastics for universal ROPS mounting), operator education and training, social marketing, or other innovative approaches will be considered. Business models that leverage partnerships with dealers, equipment manufacturers, insurers or other stakeholders to stimulate tractor upgrades or ROPS retrofitting will also be considered.

NIOSH grant/cooperative agreement funds cannot be used to provide rebates, incentives or subsidies for retrofitting, upgrading or replacing tractors.

TABLE OF CONTENTS FOR AN AG CENTER APPLICATION

Applicants must use the PHS 398 version, and the instructions, which are current at the time of their application. The applications submitted in response to this announcement are complex. The scientific and programmatic information needed to properly assess them is not fully accommodated within the basic PHS 398. Consequently, applicants will need to modify and expand the PHS 398 to properly organize the necessary information for reviewers. To help facilitate an effective and efficient peer review process, each individual core, program or project (i.e., research, prevention/intervention or education/ translation) should constitute a complete, discrete unit within the application with minimal duplication elsewhere. All applicants should use the following outline:

• PHS 398 Face Page (Form Page 1)
  
  
• Form Page 1-continued (only if Multiple PD/PIs are proposed)
  
  
• Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells. Use Form Page 2, additional Project/Performance Site pages and additional continuation pages as needed.
  
  
• Complete Table of Contents
  
  
• Detailed Budget for the Initial Budget Period for entire Ag Center (1^st 12 month budget for all components in the order they appear in the application) Form Page 4
  
  
• Budget for the Entire Proposed Project Period (all years, all components) Form Page 5
  
  
• Biographical Sketch for Center Director/co-Directors
  
  
• Other Support for Center Director/co-Directors
  
  
• Other Biographical Sketches (for people relevant to overall Center)
  
  
• Other Support for Key Personnel (relevant to overall Center)
  
  
• Resources (facilities, scientific environment, physical resources, etc., relevant to overall Center)
  
  
• Overall Description of the Center for Agricultural Disease and Injury Research, Education, and Prevention (up to 10 pages)
  
  
• Past Performance/Accomplishments in Last Project Period (for existing centers)
  
  
• Past Performance/Accomplishments Relevant to Ag Center goals (for new applicants)
  
  
• Institutional Commitment to the Ag Center (up to 2 pages)
  
  
• Identification of States that will be involved with the Ag Center
  
  
• Human Subjects summary table that lists all the projects and human subjects information (project title, performance sites, FWAs, IRB approval date/status)
  
  
• Administrative and Planning Core Cover Sheet (with section title, PI Name and table of contents for the section)
  
  
• Administrative and Planning Core Description (see outline and page limits below)
  
  
• Pilot/Feasibility Projects and Emerging Issues Program Cover Sheet with section title, PI Name and table of contents for the section)
  
  
• Pilot/Feasibility Projects and Emerging Issues Program (see outline and page limits below)
  
  
• Outreach Program Cover Sheet (with section title, PI/Program Director, and table of contents for the section)
  
  
• Outreach Program (see outline and page limits below)
  
  
• Research Core Cover Sheet (should serve as table of contents for the section by including each project title, PI, type of project (R01, etc.) and 1^st page of each project)
  
  
• Individual Research Core Project Plans (A, B, etc. see outline and page limits below)
  
  
• Prevention/Intervention Core Cover Sheet (should serve as table of contents for the section by including each project title, PI, type of project (R01, etc.) and 1^st page of each project)
  
  
• Prevention/Intervention Project Plans (A, B, etc. see outline and page limits below)
  
  
• Education/Translation Core Cover Sheet (should serve as table of contents for the section by including each project title, PI, type of project (R01, etc.) and 1^st page of each project)
  
  
• Education/Translation Project Plans (A, B, etc. see outline and page limits below)
  
  
• Evaluation Program Cover Sheet should serve as table of contents for the section by including each project title, PI, type of project (R01, etc.) and 1^st page of each project)
  
  
• Evaluation Program (see outline and page limits below)
  
  
• Checklist
  
  
• Appendix
• Note: Each individual core, program or project (research, prevention, intervention, education, or translation) should constitute a complete, discrete unit within the application, and should use the following outline:
  
  PHS 398 Face Page with Items 1-8 completed
• Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells. Use Form Page 2, additional Project/Performance Site pages and additional continuation pages as needed.
• Table of Contents
• Highlights of Accomplishments for Past Project Period (if part of existing Ag Center, 2 pages)
• Detailed Budget for the Initial Budget Period for Individual Core, Program, Project or Component (Form Page 4)
• Budget for the Entire Proposed Period for Individual Core, Program, Project or Component (Form Page 5)
• Biographical Sketches for Program Directors/Principal Investigators
• Other Biographical Sketches
• Other Support
• Resources (facilities, scientific environment, physical resources)
• Research Plan (or Program Plan)
  • Introduction (for resubmission applications, 1 page)
  • Specific Aims (1 page)
  • Research Strategy (or Program Strategy)--follow the page limits specified below
    • Significance
    • Innovation
    • Approach
    • Preliminary Studies for New Applications/Progress Report for Renewal Applications (see note below)
• Inclusion Enrollment Report (renewal or revision applications only)
• Bibliography and References Cited/Progress Report Publication List
• Protection of Human Subjects
• Inclusion of Women and Minorities
• Targeted/Planned Enrollment Table
• Inclusion of Children
• Vertebrate Animals
• Select Agent Research
• Multiple PD/PI Leadership Plan
• Consortium/Contractual Arrangements
• Letters of Support (e.g., consultants, collaborators, including NIOSH)
• Resource Sharing Plan(s)
• Checklist

Research Strategy Page Limits for Individual Projects: 12 pages for each R01-type project; 6 pages for each R03, R18 and R21-type project.

Preliminary Studies/Progress Report for Individual Projects: may be included within the Significance, Innovation or Approach sections of the Research Strategy; may be a separate section of the Research Strategy; may be placed in different order within Research Strategy than shown above.

AP Core, Pilot/Feasibility Projects and Emerging Issues Program, Outreach Program, and Evaluation Program: should follow the outline provided above. The Research Plan section may be modified (Program Plan) to accommodate these programs. In each of these cases, the section equivalent to the Research Strategy (i.e., Program Strategy) noted above is limited to 10 pages.

Applications must conform to PHS 398 typeset limitations. All pages should be numbered sequentially throughout the application beginning with the Face Page as Page 1.

Page limits (and guidance) in the PHS398 instructions, and subsequent update notices, should be adhered to unless superceded by limits (and guidance) specified in this announcement. Applications that do not observe the required page limitations (or other guidance) may not be reviewed.

Appendices are optional. NIOSH, AHRQ and NIH issued a notice on 15 April 2010 about limits on appendix materials that may be submitted with grant applications. Appendix materials must be well organized, clearly labeled as to the relevant section of the application, and ordered similarly to the application contents.

Do not use the Appendix to circumvent the page limitations.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date(s): January 4, 2011; November 2, 2011; November 4, 2012.
Application Receipt Dates(s): February 4, 2011; December 2, 2011; December 4, 2012.
Peer Review Date(s): April 2011; February/March 2012; February/March 2013.
Council Review Date(s): May 2011; May 2012; May 2013.
Earliest Anticipated Start Date: July 1, 2011; July 1, 2012; July 1, 2013.
Additional Information To Be Available Date (Url Activation Date): Not applicable.

3.A.1. Letter of Intent

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

• Descriptive title of the proposed application
• Name, address, and telephone number of the Center Director
• Number and title of this funding opportunity
• Descriptive title for each component (core, program or project)
• Name of each core, program or project leader
• For individual research, prevention, intervention, education, translation or evaluation projects, indicate the type of project (R01, R03, R21, R18)
• An indication where human or animal subjects will be involved
• Other key personnel, and participating or collaborating institutions.

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

M. Chris Langub, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mailstop E74
Atlanta, GA 30333
Telephone: (404) 498-2543
FAX: (404) 498-2571
Email: [email protected]

Overnight Mail Address:
2400 Century Parkway NE (4^th Floor), Atlanta, GA 30345-3114

3.B. Submitting an Application to NIOSH

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 paper copies of the application and 5 CDs of the appendix materials (if any) must be sent to:

M. Chris Langub, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mailstop E74
Atlanta, GA 30333
Telephone: (404) 498-2543
FAX: (404) 498-2571
Email: [email protected]

Overnight Mail Address:
2400 Century Parkway NE (4^th Floor), Atlanta, GA 30345-3114

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the NIOSH. Incomplete and/or non-responsive applications will not be reviewed.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

NIOSH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review, unless the applicant withdraws the pending application. NIOSH will not accept any application that is essentially the same as one already reviewed. However, NIOSH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

Ag Center applications previously submitted to PAR-06-057, but not funded, must be prepared as NEW applications. A new application is expected to be substantially different in content and scope with more significant differences than would normally be encountered in a resubmitted application. It should exhibit a significant change in direction and approach and include substantial changes in all sections of the Research Plan. The application must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the 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.
5. Funding Restrictions

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

Pre-award costs are not allowable.

6. Other Submission Requirements

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A.

PHS 398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, unless specified otherwise in this announcement.

For resubmission applications, an Introduction is required and is limited to 3 pages.

Budget Component

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the two application copies to the NIOSH Scientific Review Officer listed in Section IV.3.B.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may not be considered in the review process.

Resource Sharing Plan(s)

All applicants must include a plan for sharing research data in their application. The HHS/CDC data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements Release and Sharing of Data . 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 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.

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 (see the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc.) 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.

Section V. Application Review Information

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1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

\Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CDC/NIOSH and in accordance with HHS peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

Initial Merit Review

Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIOSH in accordance with HHS/NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below. For additional information on the enhanced peer review process to be used for this announcement, see http://enhancing-peer-review.nih.gov/.

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

• Undergo a selection process in which all Center applications will be discussed and assigned a priority score;
  
  
• Receive a written critique consisting of a summary evaluation of the overall Center program and a separate assessment of the:
  • Administrative and Planning (AP) Core;
  • Pilot/Feasiblity Projects and Emerging Issues Program;
  • Outreach Program;
  • individual research project proposals*;
  • individual prevention/intervention project proposals*;
  • individual education/translation project proposals*; and
  • the Evaluation Program.
    
    
• Receive a second level of review by the NIOSH Secondary Review Committee.
  
  * Note that individual research, prevention/intervention, education/translation or evaluation project proposals may undergo a review process in which only those deemed to have the highest scientific and technical merit are discussed and assigned an impact/priority score.

The mission of CDC is to promote health and quality of life by preventing and controlling disease, injury, and disability. Major goals of NIOSH research and training programs are to: identify the risks and conditions associated with occupational diseases and injuries, explore methods for reducing risks and preventing/minimizing exposure to hazardous conditions in the workplace, and to translate significant scientific findings into prevention practices or products that effectively reduce work-related illnesses and injuries. NIOSH-supported Ag Centers help engage well-qualified scientists, special resources and the creativity available in the extramural community in improving agricultural safety and health for workers in the US and addressing the Nation’s occupational safety and health research needs. The scientific review group will address and consider each of the review criteria in assigning the application's overall score, weighting them as appropriate for each application.

Review Criteria for the Overall Center Application

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the proposed center to exert a sustained, powerful transformative influence on agricultural health and safety using the following five scored review criteria, and the additional review criteria listed (Multidisciplinary and/or Interdisciplinary Nature of the Center) and, as applicable, Review Criteria for Renewal Applications.

Scored Review Criteria

Reviewers will consider the five scored review criteria below in determining scientific and technical merit of the Center, and will give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a component that by its nature is not innovative may be essential to support the Center. However, each individual part must be scientifically and technically sound, and clearly contribute in an integrated manner to the overall Center mission.

Significance. Does the Center address important problems or critical barriers to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, or best practices be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the Center likely to have an impact in meeting regional or national agricultural safety and health needs through effective research, intervention, translation, outreach, education and partnership activities? How will scientific knowledge be advanced by the Center? How will impact(s) be measured? Is there evidence or indications of collaborative relationships which are likely to contribute to the knowledge, benefits and sustainability of prevention intervention efforts to improve agricultural health and safety?

Investigator(s). Do the experience and scientific leadership of the Center Director (or co-Directors) allow him/her to effectively direct a large complex multidisciplinary program? Has the Center Director (or co-Directors) demonstrated the appropriate ability and experience to coordinate the interactions of the Research Projects with effective utilization of cores to achieve programmatic goals? Are the level of commitment and ability to develop a well-defined central focus adequate? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the leadership ability and scientific stature of the Center Director and his/her ability to meet the program’s demands of time and effort adequately described? Are the qualifications of the Center Director and Program Directors as evidenced by education, experience and accomplishments adequate to accomplish the goals and mission of the Center? Does the investigative team bring complementary and integrated expertise to the projects?

Innovation. Does the application challenge and seek to shift current paradigms or industry practices by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches, methodologies, practices, instrumentation, or interventions proposed? Does the Center propose new and novel projects? Does the Center appropriately build on current projects? Are new areas of investigation proposed that are challenging and have the potential for success? To what degree does the proposed program design address the distinct characteristics, specific populations and health needs in agricultural safety and health?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the Center is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves research involving human subjects or a clinical investigation, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is the Center cohesive in integrating all projects, facilitating interdisciplinary and trans-disciplinary interaction and likely to produce results that are translatable to occupational safety and health? For existing Centers, has the organization and structure of the Center contributed to producing measurable results and accomplishments? Is there an evaluation plan or program in place for the entire Center? Does the Center address national goals with a focus on regional issues? Is there appropriate collaboration with public and private community organizations, professional groups, industry and labor that will enhance the work of the Center and provide continuity? Is there a plan for dissemination of project results?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of institutional commitment as evidenced by sufficient resources, technical support and administrative arrangements and facilities that facilitate collaboration among researchers? Is there a plan for reaching out to other university environments, state agencies and professional groups? Do the presence, stature, and effectiveness of the Center represent an established organizational component within the institution?

In addition to the above scored review criteria, the following criteria will be considered in determining scientific merit and the impact score of the Center.

Multidisciplinary, Interdisciplinary Nature of the Overall Center

Interdisciplinary Nature of Activities. Are the projects integrated around a clearly defined mission, focus areas or a central theme? Are there plans to effectively pursue interdisciplinary research, prevention, intervention, outreach, education, translation or evaluation objectives? Does the program propose a plan for the development of interdisciplinary collaboration among all components of the program?

Coordination and Cohesiveness. Is there evidence of adequate integration of the various cores, programs and projects? Is there evidence for the translation and delivery of the research findings to appropriate audiences?

Synergy of the Program. Is there evidence of meaningful interdisciplinary or multidisciplinary collaboration and synergistic potential among the various cores, programs and projects? Is the whole greater than the sum of the parts? Is the size of the program sufficient to afford effective interaction focused on a specific central mission (or theme), but sufficiently diverse in scientific disciplines to achieve meaningful contributions toward impacting agricultural health and safety at the regional or national level?

Is there evidence of integration/interaction between health and non-health related portions of the Center? Is there a systematic focus on outcomes and impacts?

Review Criteria for Renewal Applications

For renewal applications, the following criteria will be considered for the overall Center: Have existing Centers made significant contributions to improving agricultural safety and health as demonstrated by their accomplishments? Is there evidence of progress and achievements specific to this program since the previous competitive review? Is there evidence of integration and synergy among the projects and cores within the program? Is there documentation through publications, conferences, etc. that demonstrates that collaboration between or among projects has occurred? Is there evidence that the cores have met their objectives and been well utilized by the individual research projects? Is there adequate justification for adding new projects or cores or for deleting components previously supported? Is there evidence of transfer of research findings? Have the specific commitments and plans for the Center from the previous project period been met?

Review Criteria for the Administrative and Planning (AP) Core

The following scored review criteria will be used to assess the AP Core:

Adequacy of Administrative Core. Are there adequate administrative and management plans to support all operational facets of the Center? Is the Center Director adequately supported and sufficient management depth to provide long-term continuity of Center leadership? Does the administrative structure facilitate communication among Center leaders and project scientists? Are plans for routine management, allocation of funds and partnerships designed to effectively achieve Center objectives? Is there sufficient evidence that the lines of authority and the administrative structure are designed for effective management of the Center?

Evidence of an internal plan to promote integration and coordination. Does the program’s internal plan promote coordination of interdisciplinary research and stimulate collaborations among constituent research projects and cores, particularly with regard to biomedical and non-biomedical project interactions?

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

Qualifications of administrative staff. Are the qualifications, duties and time commitments of administrative staff appropriate to contribute to the needs and conduct of the program s research activities?

Adequacy of Internal/External Advisory Committees. Are there appropriate plans for organizing and convening internal and external committees to advise the Center Director? Is the External Advisory Committee (EAC) comprised of leaders and stakeholders from the community with expertise appropriate for the projects and mission of the Center? Does the role of the EAC include oversight and making recommendations to the Center which are considered and adopted?

Review Criteria for the Pilot/Feasibility Projects and Emerging Issues Program

The following scored criteria will be used to assess the Pilot/Feasibility Projects and Emerging Issues Program:

Adequacy of Pilot/Feasibility Projects Program. Are the goals for the program well described? Is the plan to conduct the program adequate (includes procedures for scientific/technical review, funding projects, monitoring progress, and documenting outcomes)? Does the applicant encourage participation by other investigators within the institution or at regional institutions? Is the plan for announcing the Pilot or Feasibility Projects Program adequate? Does the Center plan to retain copies of all proposals, with documentation of reviews, relative ranking, and final action? Is there a mechanism for tracking the results of each study?

Adequacy of Emerging Issues Plan. Does the application include a clear explanation about the use of discretionary funds for emerging issues? Is there mechanism or process for reporting the outcomes, findings, results or impacts of the use of emerging issue funds? Are priority areas identified as emerging issues?

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

Qualifications of administrative staff. Are the qualifications, duties and time commitments of administrative staff appropriate to contribute to the needs and conduct of the program s research activities?

Review Criteria for the Outreach Program

The following scored review criteria will be used to assess the Outreach Program:

Adequacy of Outreach Plan. Does the program adequately describe activities that will impact other institutions or agencies located within the Ag Center 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 Communication Plan. Does the project include a cohesive plan for timely dissemination and translation of evidence-based techniques, tools or programs that integrate health protection and health promotion? Are appropriate communication interventions used to promote the adoption of evidence-based health protection practices? Does the project include strategic partnerships and collaborations to diffuse evidenced-based practices for preventing work-related illness, injury, and death into the workplace? Is there a process for ensuring that the communication materials developed are culturally, linguistically and educationally appropriate?

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

Qualifications of administrative staff. Are the qualifications, duties and time commitments of administrative staff appropriate to contribute to the needs and conduct of the program s research activities?

Review Criteria for Research, Prevention/Intervention, Education/Translation Core Projects

Review of individual projects conducted in a manner similar to the review of individual investigator-initiated grant applications (R01, R03, R21, and R18).

Overall Impact. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on agricultural health and safety in consideration of the following five scored review criteria, and the project’s contribution to the overall Center program.

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

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, or practices be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If the study is successful, would it lead to incremental advance, or would it provide a substantial (transformative) step forward that would likely not be achieved through mechanisms other than this multi-project program? If successful, will the project result in knowledge or resources that could be utilized to agricultural health and safety? If successful, would the project provide data, information, and knowledge to prevent or reduce fatalities or non-fatal injuries? Will the project provide rigorous scientific data that might be used for effective decision-making?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Innovation. Does the application challenge and seek to shift current research, prevention/intervention, or education/translation paradigms (or industry practices) by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches, methodologies, practices, instrumentation, or interventions proposed? Does the project address an innovative hypothesis or critical barrier to progress in the field? Does the project address an innovative hypothesis or critical barrier to progress in understanding a pertinent issue, concern or problem in agricultural health and safety?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves research involving human subjects or a clinical investigation, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does the project apply an integrated approach to address a national agricultural health and safety goal with appropriate focus on a regional issue?

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

In addition to the above scored review criteria, the following criterion will be considered in determining scientific merit and the impact score of the Center.

Contribution to Overall Center Program. Reviewers will evaluate each project for its contribution to the overall goals of the Center:

• Does the project contribute scientifically to the overall proposed mission or programmatic theme (i.e., the importance of the ideas or aims, the rationale and originality of the approach, the feasibility of the methods and the value of the result)?
• Will the specific scientific objectives of each project benefit significantly from, or depend upon, collaborative interactions with other projects in the program (i.e., objectives that can be uniquely accomplished, specific contributions to the accomplishments of objectives in other projects, objectives that can be accomplished with greater effectiveness and/or economy of effort, etc.).
• For renewals, reviewers will evaluate whether previous specific aims, as funded, have been accomplished and whether the new research goals are logical extensions of ongoing work.

Review Criteria for the Evaluation Program

The following scored review criteria will be used to assess the Outreach Program:

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

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

Qualifications of administrative staff. Are the qualifications, duties and time commitments of administrative staff appropriate to contribute to the needs and conduct of the program s research activities?

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

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

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children. When the proposed project involves human subjects or a clinical investigation, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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

Resubmission Applications. When reviewing a Resubmission application (formerly an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly a competing continuation application), the committee will consider the progress made in the last funding period.

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

Additional Review Considerations

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

Applications from Foreign Organizations. Not applicable.

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

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• scientific and technical merit of the proposed Center as determined by scientific peer review;
• availability of funds;
• relevance of the proposed Center to NIOSH program priorities;
• geographic balance of Centers among regions of the country;
• statutory and program purposes to be accomplished;
• the extent to which the components of the proposed program would be coordinated into one multi-disciplinary effort within the center;
• the extent to which the center's activities would be coordinated with similar efforts by other organizations;
• the commitment of the applicant institution; and
• the administrative and managerial capability of the applicant.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

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1. Award Notices

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

If the application is under consideration for funding, HHS/CDC will request "just-in-time" information from the applicant. For details, applicants may refer to the HHS Grants Policy Statement .

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.

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 CDC/NIOSH grant and cooperative agreement awards incorporate the HHS Grants Policy Statement by reference as part of the Notice of Award.

The 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 courteous copy to the PD/PI 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, CDC and NIOSH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial 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 NIOSH as defined below.

2.A.1. Center Director/Principal Investigator (CD/PI) Rights and Responsibilities

The Recipient will have the primary responsibility for management, administrative and scientific aspects of the Center including data, resources and operations, including, but not limited to the following:

The 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 all technical, scientific and administrative aspects of all component Center activities 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; plan, conduct, and analyze data; and publish results, interpretations, and conclusions of studies conducted under the terms and conditions of the Ag Center award.

The applicant will collaborate with diverse groups (community-based, workers, producers, and others) in the area or region to develop, implement or evaluate interventions, prevention strategies, educational efforts translation projects, research projects or demonstration projects focused on preventing work-related injuries and illnesses among agricultural workers and their families.

The recipient will also:

• Develop linkages and communication with other governmental and non-governmental bodies involved in agricultural health and safety.
• Disseminate research results, and relevant health/safety information.
• Collaborate with other NIOSH Ag Centers to develop and utilize a uniform evaluation scheme for Ag Center research, prevention, intervention, education, translation, outreach and evaluation activities.
• Establish an external advisory committee that includes expertise from agricultural experts in the region and the nation to help guide the Ag Center.
• Serve as a center for consultation on agricultural health and safety.
• Conduct pilot research on the causes and the prevention of agricultural-related injuries (including fatalities).
• Conduct appropriate evaluation activities in coordination with other Ag Centers.
• Develop, implement and evaluate model programs for preventing injuries and illnesses among agricultural workers, farmers and their families, and
• Obtain the appropriate Institutional Review Board approvals for all institutions or individuals participating in the research project.

2.A.2. HHS/CDC Responsibilities

NIOSH Program Official (PO)

The NIOSH Office of Extramural Programs and the CDC Procurement and Grants Office will designate a Program Official (PO) for this cooperative agreement. This person will be responsible for the normal programmatic stewardship of the award and will be named in the Notice of Award (NoA). The PO will have programmatic involvement during the conduct of this activity through approval for added subprojects that have undergone NIOSH meritorious review, approval of progress report, approval of pilot study guidance/plan and human subjects protection, approval of annual summary report, advice and coordination commensurate with normal program stewardship for grants, as described below. Responsibilities of the PO include:

• Ensuring that all requirements are met prior to issuance of an initial award.
• Objective and independent evaluation of progress toward specific aims or objectives.
• Approving non-competitive continuation of the award.
• Recommending corrective actions as needed.
• Carry out administrative and technical related duties e.g., grant cycle or funding information, programmatic approvals and recommendations, consultation or technical assistance pertaining to administration requirement of award, monitor performance of the recipient, process Just-In-Time (JIT) information for research projects, approve final reports before release and distribution, communicate guidance and policy, facilitate budget recommendations, program/site visit, dissemination of grantee information such as the Annual Report and research reports.
• Provide guidance or information for addressing recipient inquiries.
• Participate in grantee meetings (as a non-voting member); facilitate development of goals and agenda for these meetings as necessary.

NIOSH Project Scientists

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

• Obtain prior NIOSH approval/clearance for involvement in project.
• Upon request of the Center (and approval by NIOSH), provide expert consultation in the area of occupational health and safety as needed.
• Serve as subject matter experts.
• Upon request of the Center (and approval by NIOSH), provide advice on formats for data reporting and coding, computer software and electronic storage of data.
• Scientific collaboration, upon request.
• Upon invitation by Center, attend meetings (as voting members) and other workshops.
• With the PO, facilitate coordination and collaboration among grantees on meeting agendas, and prevention activities and opportunities requested.
• Attend and actively participate in the planning and implementation of grantee meetings as requested.
• Facilitate collaborative efforts to compile and disseminate program results through presentations and publications.
• Publish with the awardee if mutually agreeable and warranted by the nature and extent of his/her intellectual contribution to the program or project, and
• Obtain Institutional Review Board approvals as required by CDC when CDC is engaged in research involving human subjects.

NIOSH Project Scientists will be named in the Notice of Award and will work closely with the recipient and the PO.

2.A.3. Collaborative Responsibilities

Respective Center Directors should plan to meet annually with NIOSH in Washington, DC, and budget accordingly.

Likewise, Center Directors should expect that a Coordinating Committee (CC) will be formed to facilitate the sharing of information about activities and accomplishments among the Centers. The CC will provide leadership and work collaboratively to address occupational safety and health issues at a national level.

The CC will be comprised of the Center Directors and the principal investigators from the Centers. NIOSH representatives may participate in CC meetings as appropriate, but will not have voting privileges. The CC may designate working groups comprised of staff from each Center for specific purposes. These multi-site committees could provide a means to share data, enhance translation, or help provide focus on specific issues of national importance.

To the extent practicable, CC meetings should be held annually in conjunction with major scientific meetings that center staff attend or utilize current technology suitable for distance meetings.

About every other year, NIOSH will organize a workshop, conference or meeting to encourage interactions between Ag Center scientists and NIOSH scientists. These will provide opportunities to discuss projects, progress, emerging issues, and mutual interests. Centers should plan to participate in these meetings.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIOSH may be brought to Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter 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.

3. Reporting

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.
   
   
5. Final Invention Statement and Certification form

The 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.

Prior to initiating pilot projects, grantees must provide written notification to the NIOSH Scientific Program Official named in the notice of grant award. This notification should contain a brief description of, and rationale for, the planned project, the funding amount and the proposed length of the project. The Center Director should also verify that: 1) the project complies with applicable HHS policies, 2) all necessary assurances have been obtained; and that 3) the project received an appropriate within-Center review. Studies involving clinical trials must include a Data and Safety Monitoring Plan approved by the relevant institutional review board(s) with concurrence by the NIOSH Scientific Program Official.

Although the financial plans of the NIOSH 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.

Section VII. Agency Contacts

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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:

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
Telephone: (404) 498-2530
FAX: (404) 498-2571
[email protected]

2. Peer Review Contacts:
M. Chris Langub, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mailstop E74
Atlanta, GA 30333
Telephone: (404) 498-2543
FAX: (404) 498-2571
Email: [email protected]

Overnight Mail Address:
2400 Century Parkway NE (4^th Floor), Atlanta, GA 30345-3114

3. Financial or Grants Management Contacts:

Maryann Monroe
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Telephone: 412-386-5075
FAX: 412-386-6429
Email: [email protected]

4. General Questions Contacts:

Technical Information Management Section
HHS/CDC Procurement and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Telephone: 770-488-2700
Email:

Section VIII. Other Information

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Required Federal Citations

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 on 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 Research
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). The website can be found at; http://www.nchstp.cdc.gov/od/infocenter/npin.htm.

Patient Care
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 (SF 424).

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.

Lobbying Restrictions
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.

Capability Assessment
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.

Research Integrity
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).

For example:
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, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) http://www.cdc.gov/od/foia/index.htm.

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. Reviewers may consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the impact/priority score. 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 (Public Law 89-665, 80 Stat. 915)
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:

a. Section 106 of the National Historic Preservation Act (NHPA) states:

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.