CENTERS FOR AGRICULTURAL DISEASE AND INJURY RESEARCH, EDUCATION AND PREVENTION

Release Date:  January 29, 2001

RFA:  RFA-OH-01-004

National Institute for Occupational Health and Safety

Letter of Intent Receipt Date:  February 16, 2001
Application Receipt Date:       March 28, 2001

PURPOSE

National Institute for Occupational Health and Safety (NIOSH), Centers for 
Disease Control and Prevention (CDC), announces the availability of fiscal 
year (FY) 2001 funds for cooperative agreement (U50) applications from single 
institutions or consortia of institutions to establish Centers for 
Agricultural Disease and Injury Research, Education and Prevention (Ag 
Centers).  The purposes of the Ag Centers are to conduct research, education, 
and prevention/intervention programs that address agricultural safety and 
health problems in the geographic region served (multi-state), as well as 
nationally.

The mission of NIOSH is to support research and research training relating to 
the etiology, mechanisms, diagnosis, treatment and prevention of human 
diseases and disorders caused by occupational factors including those found in 
agriculture.  To assist in this mission, in 1990, Congress established a 
National Program for Occupational Safety and Health in Agriculture within 
NIOSH to lead a national effort in surveillance, research, and intervention.  
This program has had a "significant and measurable impact" on reducing adverse 
health effects among agricultural workers.  As part of this program, nine Ag 
Centers were established nationally.  These Ag Centers conduct research, 
education, and prevention projects to address the nation=s pressing 
agricultural safety and health problems.  Geographically, the Ag Centers are 
distributed throughout the nation to be responsive to the agricultural safety 
and health issues unique to the different regions.  Through these efforts, the 
Ag Centers help to ensure that actions to prevent disease and injury in 
agriculture are taken based upon scientific findings.  Additional information 
on NIOSH Agricultural Health and Safety activities can be found on the NIOSH 
web site at http://www.cdc.gov/niosh/agtopics.html. 

HEALTHY PEOPLE 2010

CDC is committed to achieving the health promotion and disease prevention 
objectives of "Healthy People 2010," a national activity to reduce morbidity 
and mortality and improve the quality of life.  This announcement is related 
to the focus area of Occupational Safety and Health.  For a copy of "Healthy 
People 2010" (Full Report: Stock No. 017-001-00547-9), write or call:  
Superintendent of Documents, Government Printing Office, Washington D.C. 
20402-9325, telephone (202) 512-1800 or visit the internet site: 
http://www.health.gov/healthypeople.

ELIGIBILITY REQUIREMENTS

Eligible applicants include State and private universities and university-
affiliated, not-for-profit and for-profit medical centers within the United 
States (U.S.).  Applications from minority and women investigators are 
encouraged.  The restriction of eligible applicants is due to the FY 1990 
appropriations language which initiated this program and states that centers 
for agricultural occupational safety and health will be established at 
universities.

Because of programmatic and regional differences throughout agriculture in the 
U.S., Ag Centers will be established across the country to address this 
diversity, and geographic distribution of the Ag Centers will be an important 
factor in making awards. 

MECHANISM OF SUPPORT

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

The total project period for an application submitted in response to this 
present RFA may not exceed five (5) years.  The anticipated award date is 
September 1, 2001.  The award and level of support depends on receipt of 
applications of high scientific merit. 

AVAILABILITY OF FUNDS

Approximately $7,500,000 is available in FY 2001 to fund 7 to 9 awards.  The 
maximum amount that may be requested is $1,000,000 total cost (direct and 
indirect) per year.  This level of expenditure is contingent upon the receipt 
of a sufficient number of applications directly relevant to the objectives of 
this RFA that are of high scientific quality as judged by a peer-review merit 
evaluation and the actual availability of funds. 

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

Use of Funds

Applicants should allocate funds for travel for two project staff (the Ag 
Center Director and one other person) to attend annual meetings held during 
each project year.  Travel funds should also be planned for semi-annual 
meetings of Ag Center Directors as a Coordinating Committee (see Collaborative 
Responsibilities under Terms and Conditions of Award).  For planning purposes, 
assume that the meetings will be held in Washington, DC.

PREAPPLICATION CONFERENCE CALL

Applicants are invited by NIOSH to participate in a preapplication technical 
assistance telephone conference call on February 12, 2001 at 1:00 PM (Eastern 
time) to discuss:  programmatic issues regarding this program,  how to apply, 
and questions regarding the content of the RFA.  The conference name is 
Agriculture Centers program.  The telephone bridge number is 1-800-311-3437.  
Interested parties will need the conference code (199814) to participate.

RESEARCH OBJECTIVES

Background

Agriculture consistently ranks among the industries with the highest rates of 
work-related injuries and deaths in the United States.  The agricultural 
environment presents a number of unique work settings which vary across the 
United States.  This is the only industry in which the workplace is often also 
a home.  The Ag Centers were established to address the unique occupational 
challenges of the agricultural environment.  

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

This cooperative agreement program is designed to strengthen the occupational 
and public health infrastructure by building on a decade of Agricultural 
Center accomplishments aimed at integrating resources for occupational safety 
and health research and public health prevention programs at the State and 
local levels.  It is designed to address the research, education, and 
prevention activities that are unique to agriculture in all geographic 
regions.  To achieve this objective, the program will support Agricultural 
Centers that integrate disease and injury research, education, and prevention. 

Project Goals

Note, for this RFA the term "projects" is defined as research, education or 
intervention/prevention projects.  

This initiative is intended to assemble a cross-disciplinary, multi-
institutional and geographically diverse group to address the current issues 
in agricultural safety and health.  To accomplish this objective, it is 
envisioned that an Ag Center would: 
1.  Conduct research related to the prevention of occupational disease and 
injury among agricultural workers and their families.
2.  Develop, implement and evaluate education and outreach programs for  
promoting health and safety for agricultural workers and their families.  This 
would include providing consultation and/or training to researchers, health 
and safety professionals, graduate/professional students, and agricultural 
extension agents and others in a position to improve the health and safety of 
agricultural workers.
3.  Develop, implement and evaluate model programs for the prevention of 
illness and injury among agricultural workers and their families. 
4.  Develop linkages and communication with other governmental and non-
governmental bodies involved in agricultural health and safety with special 
emphasis on communications with other agricultural health and safety programs. 

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

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

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

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

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

Ag Centers should include the development, implementation and evaluation of  
model education, outreach, and intervention programs promoting health and 
safety for agricultural workers and their families.  These programs should 
include culturally-appropriate materials (such as, consideration of language) 
and multi-media presentations, as appropriate, to reach the target 
agricultural populations within the Ag Center Districts.  Emphasis should be 
given to reaching underserved agricultural populations such as hired farm 
laborers, migrant/seasonal workers, women and children.

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

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

Useful References

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

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

ESSENTIAL CHARACTERISTICS OF AN AGRICULTURAL CENTER COOPERATIVE AGREEMENT 

Overall Characteristics
o  The Ag Center cooperative agreement will support a broadly based multi-
disciplinary research, education and prevention program.  An Ag Center is 
expected to have the following components which together address the 
objectives of a center:

1.  An Administrative and Planning Core.  This component should not exceed 15% 
of the direct cost budget.
2.  A Multi-Disciplinary Research Core.  This component should be at least 40% 
of the direct cost budget.
3.  An Education and Outreach Core.  This component should be at least 10% of 
the direct cost budget.
4.  A Prevention/Intervention Core.  This component should be at least 10% of 
the direct cost budget.

o  There must be a demonstrated commitment of the applicant institution to the 
support and encouragement of the Ag Center.  Such support could be 
demonstrated by release time of faculty, capital improvements that will 
facilitate the research, and/or assistance in the acquisition of scientific 
equipment and supplies.

NON-ALLOWABLE COSTS FOR NIOSH AGRICULTURAL CENTER COOPERATIVE AGREEMENT

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

ESSENTIAL ELEMENTS OF AN AGRICULTURAL CENTER 

ADMINISTRATIVE AND PLANNING CORE 
(SHOULD NOT EXCEED 15% OF THE ANNUAL DIRECT COST)

The Administrative and Planning Core must have strong leaders committed to the 
project, who are capable of providing scientific leadership and who are 
willing to accept responsibility for the administration and integration of the 
program.  Assessment of the ability of the program principal investigator to 
lead  a tightly integrated program of collaborative research, education and 
prevention will be a significant consideration in the evaluation of the 
application.  

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

o  Appropriate and adequate organization and facilities for the conduct of the 
research, education, training and intervention/prevention activities such as 
seminars, workshops, reference collection, computer support, etc.

o  An Internal Advisory Committee formed of the individual Center Core leaders 
that will assist the principal investigator in making scientific and 
administrative decisions in the operation of the program.   

o  An External Advisory Committee comprised of at least three members who are 
recognized as leaders in agricultural health and safety and regional 
agricultural experts that will provide overall guidance and advice to the 
principal investigator and program investigators on program direction.  

MULTI-DISCIPLINARY RESEARCH CORE
(SHOULD BE AT LEAST 40% OF THE ANNUAL DIRECT COSTS)

Two types of projects (Pilot and Research) will be supported as part of the Ag 
Centers program, and both types must be present.  It is important that each 
project (Pilot and Research) be of sufficient scientific merit to warrant 
independent support and that each project is an integral part of the Ag 
Center.  To be funded, an Ag Center must have at least one Pilot project and 
two Research projects that are judged to have significant and substantial 
scientific merit on their own.  Collaborative research is encouraged between 
Ag Centers and with the NIOSH intramural program.

Research projects should be consistent with the R01-type projects that are 
typically awarded by NIOSH and NIH.  The project period for a Research project 
is usually five years but may be less.  These projects will adhere to the 
submission guidelines for a R01 application following the PHS 398 application 
instructions.   Each research project should begin with a cover sheet that 
identifies the principal investigator, the title, and type of research project 
(pilot or R01).  The next page is the form page BB of the 398 which provides 
the description, performance sites, and key personnel.  The next pages are for 
the Research Plan which cannot exceed 25 pages for items d - g (see table of 
contents for an Ag Center Application section).  The budget information, other 
support, etc. should be included in the appropriate sections of the 
application.   

Pilot projects are intended to provide Ag Center investigators an opportunity 
to obtain the preliminary research data needed to help direct and maintain 
ongoing research, education, and prevention/intervention programs and for the 
submission of a CDC, NIH, EPA, or other peer-reviewed Research Project Grant 
applications.  The maximum project period for a Pilot project is 24 months.  
Each pilot research project should begin with a cover sheet that identifies 
the principal investigator, the title, and type of research project (Pilot).  
The next page is the form page BB of the 398 which provides the description, 
performance sites, and key personnel.  The next pages are for the Research 
Plan.  Follow the instructions for a NIOSH Exploratory/Developmental grant 
(R21, see NIH guide:  
http://grants.nih.gov/grants/guide/rfa-files/RFA-OH-00-006.html, for additional 
information on R21 applications), and cannot exceed 15 pages for items d - g 
(see table of contents for an Ag Center Application section).  The budget 
information, other support, etc. should be included in the appropriate 
sections of the application.   

NOTE:  NIOSH will inform successful applicants of the procedures for adding 
Pilot, Research, Education/Outreach, or Prevention/Intervention projects in 
future years of support.  Thus, the application should contain only projects 
for which funds are requested.

EDUCATION AND OUTREACH CORE

Applicants should include a well developed Education and Outreach Core to 
target the key agricultural health and safety needs in the Ag Center District. 
 Projects should involve regional agricultural stakeholders in addressing 
educational needs and in the implementation of innovative strategies for 
meeting those needs.  Partnerships and collaborative relationships are 
encouraged between Ag Centers and NIOSH intramural programs and other 
extramural partners including NIOSH Education and Research Centers (ERCs), 
Training Grant (TG) recipients, and other NIOSH funded agricultural programs.

The Education and Outreach Core should begin with a cover sheet that 
identifies it as the beginning of the Core, and list the name of the Core 
leader.  This page is then followed by as many subsections as there are 
education projects.  Each subsection begins with a header page that identifies 
the project leader and title of the project.  The next page is the form page 
BB of the 398 which provides the description, performance sites, and key 
personnel. The rest of the project description should follow the framework for 
the research projects which is described above.

PREVENTION/INTERVENTION CORE.

Applicants should include model programs, including intervention/intervention 
effectiveness research programs, for the prevention of illness and injury 
among agricultural workers and their families in the region.  Programs should 
be designed to involve regional agricultural stakeholders in addressing 
regional needs and in the implementation of innovative strategies for meeting 
those needs.  These programs should include the active participation of the 
involved target populations, and include an evaluation component.  
Partnerships and collaborative relationships are encouraged between Ag Centers 
and NIOSH intramural programs and other extramural partners, including NIOSH 
Education and Research Centers (ERCs), Training Grant (TG) recipients, and 
other NIOSH funded agricultural programs.

The Prevention/Intervention Core should begin with a cover sheet that 
identifies it as the Prevention/Intervention Core, and list the name of the 
Core leader.  This page is then followed by as many subsections as there are 
education projects.  Each subsection begins with a header page that identifies 
the project leader and title of the project.  The next page is the form page 
BB of the 398 which provides the description, performance sites, and key 
personnel.  The rest of the project description should follow the framework 
for the research projects which is described above. 

TABLE OF CONTENTS FOR AN AG CENTER APPLICATION

In order to facilitate the preparation and review of the Ag Center 
application, the following Table of Contents should be used.  It is a minor 
modification of the 398 table of contents which should be followed as a guide.
Face Page 
Ag Center Description, Performance Sites, and Personnel, Form page BB (use 
additional continuation pages as needed)
Table of Contents 
Detailed Budget for the Initial Budget Period for the entire Ag Center
Budget for the Entire Proposed Period of Support for the Entire Ag Center
Detailed Budget for each Project for the Initial Budget Period Organized by 
Cores
Budget for the Entire Proposed Period for each Project Organized by Cores

Biographical Sketch- Principal Investigator/Program Director
Other Biographical Sketches
Other Support
Overall Description of the Ag Center (2 page maximum)
Past Performance/Accomplishments in Last Project Period (existing Ag Center)
Past Performance/Accomplishments Relevant to Ag Center goals (new applicants)
Statement on the Institutional Commitment to the Ag Center (1 page maximum)
Identification of the States that will be involved with the project
Research Project Core Cover Sheet 
Research Project Plan A
Research Project Plan B (use as many headings as there are projects) 
Pilot Project Plan  
Education and Outreach Project Core Cover Sheet 
Education and Outreach Project Plans
Prevention/Intervention Project Core Cover Sheet
Prevention/Intervention Project Plans

Note: each project plan should use the following outline
a.  Header Page with Title and Principal Investigator"s name
b.  Description, Performance Sites, and Personnel (form page BB)
c.  Highlights of Accomplishments for Past Project Period if it was part of an 
Existing Ag Center (1 page maximum)
d.  Specific Aims
e.  Background and Significance
f.  Preliminary Studies/Progress Report
g.  Research Design and Methods 

Items d-g cannot exceed 25 pages (except pilot projects, which cannot exceed 
15 pages)

h.  Human Subjects
i.  Vertebrate Animals
j.  Literature Cited
k.  Consortium/Contractural Arrangements
l.  Consultants and Collaborators, including NIOSH

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

TERMS AND CONDITIONS OF AWARD

The Terms and Conditions of Award, below, will be incorporated in all awards 
issued as a result of this RFA. It is critical that each applicant include 
specific plans for responding to these terms.  These 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, 
and PHS Grants Policy Statement.

Under the cooperative agreement, the NIOSH purpose is to support and/or 
stimulate the recipient"s activity by involvement in and otherwise working 
jointly with the award recipient in a partner role, but it is not to assume 
direction, prime responsibility, or a dominant role in the activity.  
Consistent with this concept, the dominant role and prime responsibility for 
the activity resides with the awardee(s) for the project as a whole, although 
specific tasks and activities in carrying out the studies will be shared among 
the awardees and the NIOSH collaborators where appropriate, including the 
following.

1. Recipient Responsibilities

The recipient will coordinate project activities, scientifically and 
administratively at the awardee institution and at the other sites that may be 
supported by sub-contractors to this award.  The applicant will have primary 
authority and responsibility to define objectives and approaches,  to plan, 
conduct, and analyze data, and to publish results, interpretations, and 
conclusions of studies conducted under the terms and conditions of the 
cooperative agreement award.  Recipient will:

o  Develop and conduct research related to the prevention of occupational 
disease and injury of agricultural workers and their families, with an 
emphasis on multi-disciplinary research and the development and evaluation of 
control technologies. 

o  Develop a research protocol(s) for agricultural disease and injury 
research, education, and prevention which would include collaboration with 
regional stakeholders as appropriate. 

o  Develop, implement and evaluate model educational, outreach, and 
intervention programs promoting health and safety for the targeted 
populations. 

o  Develop, implement and evaluate model programs including control 
technologies for the prevention of illness and injury among agricultural 
workers and their families. 

o  Provide assistance and direction to community-based groups in the area for 
the development and implementation of community projects including 
intervention research and prevention demonstration projects for preventing 
work-related injuries and illness among farm workers and their families. 

o  Serve as a center for consultation and/or training for agricultural safety 
and health professionals. 

o  Develop linkages and communication with other governmental and non-
governmental bodies involved in agricultural health and safety. 

o  Disseminate research results and relevant health and safety education and 
training information. 

o  Collaborate with other CDC/NIOSH Ag Centers, to develop and utilize a 
uniform evaluation scheme for Agricultural Center research, 
education/training, and outreach/intervention activities.

o  Establish an external advisory committee including expertise from 
agricultural experts in the region and the nation to guide the Ag Center and 
Center projects/activities.

2.  NIOSH Responsibilities

o  Provide technical assistance through site visits and correspondence in the 
areas of program development, implementation, maintenance, and priority 
setting related to the cooperative agreement. 

o  Provide scientific collaboration where needed. 

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

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

3.  Collaborative Responsibilities

Part of this initiative will be the establishment of a Coordinating Committee 
(CC) that will facilitate sharing of information about activities and 
accomplishments among the Centers.  This CC will also provide leadership and 
work collaboratively to address occupational safety and health issues at a 
national level such as combined Center efforts to reduce tractor-related 
injury and fatality.  The CC will be comprised of the principle investigators 
from the Centers.  NIOSH representatives will participate in CC meetings where 
appropriate but will not have voting privileges.  The CC may designate working 
groups for specific purposes, made up of staff members from their Centers.  
One such working group would be an Ag Centers Methods Committee.  This 
multisite committee will provide a means to standardize the collection of 
evaluation materials/information across Ag Centers.  It will also provide a 
means to collect information necessary to help address accomplishments on the 
NIOSH Agricultural Initiative.  Information and materials may be collected at 
one repository location for common use by all Centers.  If there are added 
costs associated with creating and maintaining this repository, NIOSH may 
determine that a contract or other mechanism could be used to fund it.

It is anticipated that critical issues for understanding and protecting 
agricultural workers from job risks will be better defined through the 
deliberations of the CC.  The CC will combine the expertise and resources of 
the Centers with those of NIOSH to achieve a more integrated and effective 
program in agricultural health and safety.

HUMAN SUBJECTS REQUIREMENTS

If a project involves research on human subjects, assurance (in accordance 
with Department of Health and Human Services Regulations, 45 CFR Part 46) of 
the protection of human subjects is required.  In addition to other applicable 
committees, Indian Health Service (IHS) institutional review committees also 
must review the project if any component of IHS will be involved with or will 
support the research.  If any American Indian community is involved, its 
tribal government must also approve that portion of the project applicable to 
it.  Unless the grantee holds a Multiple Project Assurance, a Single Project 
Assurance is required, as well as an assurance for each subcontractor or 
cooperating institution that has immediate responsibility for human subjects. 
The Office of Human Research Protections (OHRP) negotiates assurances for all 
activities involving human subjects that are supported by the Department of 
Health and Human Services (Additional information is available at 
http://www.hhs.gov/ohrp/).

All investigators proposing research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 28, 1994 
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, August 2, 2000.  
It is also available at:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html.

ANIMAL SUBJECTS REQUIREMENTS

If the proposed project involves research on animal subjects, compliance with 
the "PHS Policy on Humane Care and Use of Laboratory Animals by Awardee 
Institutions" is required.  An applicant (as well as each subcontractor or 
cooperating institution that has immediate responsibility for animal subjects) 
proposing to use vertebrate animals in CDC-supported activities must file (or 
have on file) the Animal Welfare Assurance with the Office of Laboratory 
Animal Welfare (OLAW) at the National Institutes of Health. The applicant must 
provide in the application the assurance of compliance number and evidence of 
review and approval (including the date of the most recent approval) by the 
Institutional Care and Use Committee (IACUC).

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the Centers for Disease Control and Prevention (CDC) to 
ensure that individuals of both sexes and the various racial and ethnic groups 
will be included in CDC-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.

URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES

All applications for NIOSH funding must be self-contained within specified 
page limitations. Unless otherwise specified in a NIOSH solicitation, internet 
addresses (URLs) should not be used to provide information necessary to the 
review because reviewers are under no obligation to view the Internet sites.  
Reviewers are cautioned that their anonymity may be compromised when they 
directly access an Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit, by February 16, 2001, a letter of 
intent that includes a descriptive title of the proposed research, name, 
address, and telephone number of the Principal Investigator, identities of 
other key personnel and participating institutions, and number and title of 
the RFA in response to which the application may be submitted.

Although a letter of intent is not required, is not binding, and does not 
enter into the review of subsequent applications, the information allows NIOSH 
staff to estimate the potential review workload and to avoid conflict of 
interest in the review.

The letter of intent is to be sent to:

Price Connor, Ph.D.
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 1, Room 3070B, MS D-30
Atlanta, GA  30333
Telephone 404-639-2376
Fax 404-639-0035
Email: [email protected]

APPLICATION PROCEDURES

Although not a prerequisite for applying, applicants are encouraged to consult
with NIOSH staff concerning the technical and substantive aspects of preparing
the application.  Applicants should contact NIOSH staff by phone early in the
preparation process.  However, applicants should understand that advice given 
by staff is independent from the review process.

Applicants must use Form PHS 398 (rev. 4/98).  Application kits are available 
at most institutional offices of sponsored research and may be obtained from 
the Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, 
telephone 301/710-0267, Email: [email protected].  Application kits are also 
available at: http://grants.nih.gov/grants/forms.htm.

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Failure to use 
this label could result in delayed processing of the application such that it 
may not reach the review committee in time for review.  In addition, the RFA 
title and number must be typed on line 2 of the face page of the application 
form and the YES box must be marked.

The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has 
been modified to allow for this change.  Please note this is in pdf format.

Submit a signed original of the application, including the Checklist, and 
three signed photocopies, in one package to:

Center for Scientific Review (CSR)
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must also
be sent to:

Price Connor, Ph.D.
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 1, Room 3070B, MS D-30
Atlanta, GA  30333

Applications must be received by March 28, 2001.  If an application is 
received after that date, it will be returned to the applicant without review. 
CSR and NIOSH will not accept any application in response to this RFA that is 
essentially the same as one currently pending initial review, unless the 
applicant withdraws the pending application.  CSR and NIOSH will not accept 
any application that is essentially the same as one already reviewed.  This 
does not preclude the submission of a substantial revision of an application 
already reviewed, but such an application must follow the guidance in the PHS 
Form 398 application instructions for the preparation of revised applications, 
including an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by NIOSH.  Incomplete and/or non-responsive applications will 
be returned to the applicant without further consideration.  Those 
applications that are complete and responsive, will undergo scientific merit 
review in accordance with the criteria stated below for scientific merit by an 
appropriate peer review group convened by NIOSH.  As part of the scientific 
merit review, all applications will receive a written critique and undergo a 
process in which only those applications deemed to have the highest scientific 
merit, generally the top half of applications under review, will be discussed 
and assigned a priority score.  For these top applications, site visits may be 
included in the review process if it is deemed necessary in making the 
evaluation of scientific merit.

Following the scientific merit review, applications will then be reviewed by 
NIOSH according to the programmatic review criteria below.
  
Note: Type density and size of the entire application must conform to the 
limits provided in the 398 instructions on page 6.  Applications which do not 
conform to these limits may be returned without review and consideration for 
this RFA.

All applications will be judged on the basis of the scientific merit of the 
proposed project and the documented ability of the investigators to meet the 
objectives of the RFA.  Although the technical merit of the proposed protocol 
is important, it will not be the sole criterion for evaluation of a study.  
Other considerations, such as the importance and timeliness of the proposed 
research, education and intervention studies, access to the agriculture 
population, and the interdisciplinary nature of the studies, will be part of 
the evaluation criteria.

Following the scientific review, competitive applications will be reviewed for 
programmatic importance by a NIOSH Secondary Review Committee.

REVIEW PROCEDURES

SITE VISITS

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

A site visit is not a prerequisite and is not assured, however, for 
consideration of an application by NIOSH.  Therefore, the application is 
considered a complete document for review purposes.  Furthermore, the 
applicant should not use the site visit as an occasion for adding core units, 
research projects, or investigators, for making major changes, or for 
delivering another exposition of the application.  Rather, it should be used 
by the principal investigator and associates to elaborate on the research 
program and core units, cost effectiveness and quality control features of the 
core units, and on other Center activities for which funding is requested, as 
well as to answer reviewers" questions. The site visit team will not consider 
any component core unit that is presented for evaluation at the site visit 
which has not been included in the application.  Budgetary changes also will 
not be considered at the time of a site visit.  The findings of the site visit 
team are reported and discussed by the members of the SEP, which makes the 
final peer review recommendations and assigns the priority score.

REVIEW FACTORS

The primary consideration for a Center cooperative agreement application is 
the ability of the Center program to bring together quality research, 
education and prevention activities into an interactive, multi-disciplinary 
operation addressing agricultural issues in the region.  Quality scientific 
research is a prerequisite for the application, and without it, the 
application will fail.

Review criteria for the overall program are:

o  Responsiveness to the objectives of the cooperative agreement program, 
including the applicant"s understanding of the objectives of the proposed 
cooperative agreement and the relevance of the proposal to the objectives. 

o  Feasibility of meeting the proposed goals of the cooperative agreement 
program including the proposed schedule for initiating and accomplishing each 
of the activities of the cooperative agreement and the proposed method for 
evaluating the accomplishments. 

o  Degree to which the program design addresses the distinct characteristics, 
specific populations, and needs in agricultural research and education for the 
region. 

o  Qualifications of core scientists and the physical and intellectual 
environment of the group as a national resource for agricultural occupational 
health research and training.

o  Multidisciplinary scope of the program.

o  Degree of interrelationships, collaboration, and synergism of research that 
might be expected to derive from Center support. 

o  Leadership ability and scientific stature of the Center Director and 
his/her ability to meet the program"s demands of time and effort.

o  Provisions for coordinating Project Cores.  The Center must have 
appropriate administrative arrangements and facilities that stimulate 
collaboration among constituent projects and personnel.

o  Effectiveness of the Center in establishing or continuing a Community 
Education and Outreach Program that makes maximal use of the Center=s 
strengths in educating the public and surrounding community with regard to 
reducing agricultural injuries and/or hazard exposure.

o  Institutional commitment to the Center.

Review Criteria for Research Core Projects are:

o  Significance - Does this project address an important problem related to 
the topical research issues outlined in this solicitation?  If the aims of the 
application are achieved, how will scientific knowledge be advanced?  What 
will be the effect of these studies on the concepts or methods that drive this 
field?

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

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

o  Investigator - Is the investigator appropriately trained and well-suited to 
carry out this work?  Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers, if any?

o  Environment - Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there documentation of cooperation from 
stakeholders in the project, where applicable?  Is there evidence of 
institutional support and availability of resources necessary to perform the 
project?

Review Criteria for Education and Outreach Core Projects are:

o  Merit and significance of the proposed project as determined by such 
factors as content, originality, feasibility, potential long-term impact, 
transportability, and appropriateness for regional populations served by the 
Center. 

o  Demonstration within the proposed project plan of current knowledge of 
education practices, outcomes, and standards, specifically those related to 
learning, attitudes, motivation, and educational strategies.

o  Qualifications and education experience of the principal investigator and 
staff, particularly but not exclusively in areas relevant to the mission of 
NIOSH Ag Center.  Individuals with strong subject matter skills are expected 
to play key roles.  Personnel should demonstrate knowledge of the needs of 
their target audience in educational settings.

o  Availability of resources necessary to perform project objectives. 

o  Strength of commitment by the participating institution(s) as evidenced by 
provision of appropriate resources, services, technical support.

o  Appropriateness of the proposed budget and duration in relation to proposed 
objectives. 

o  Plans for evaluation of factors contributing to the project"s 
effectiveness.

o  Plans for distribution of results and products in the educational arena.

Review Criteria for Prevention/Intervention Core Projects are:

o  Merit and significance of the proposed project as determined by such 
factors as content, originality, feasibility, potential long-term impact, 
transportability, and appropriateness for regional populations served by the 
Center.

o  Demonstration within the proposed project plan of current knowledge of 
intervention practices and effectiveness.  Does the applicant acknowledge 
potential problem areas and consider alternative tactics?

o  Qualifications and experience of the principal investigator and staff, 
particularly but not exclusively in areas relevant to the mission of NIOSH Ag 
Center. Individuals with strong subject matter skills are expected to play key 
roles.  Personnel should demonstrate knowledge of the needs of their target 
audience.

o  Availability of resources necessary to perform project objectives.

o  Appropriateness of the proposed budget and duration in relation to proposed 
objectives. 

o  Plans for evaluation of factors contributing to the project"s 
effectiveness.

o  Plans for distribution of results and products.  

Other Review Criteria for all Projects

The scientific review group will also examine the appropriateness of proposed 
project budget and duration, the adequacy of plans to include both genders, 
minorities and their subgroups, and children as appropriate for the  
scientific goals of the research and plans for the recruitment and retention 
of subjects, the provisions for the protection of human and animal subjects, 
and the safety of the research environment.

Programmatic Review Criteria:

o  Magnitude and severity of the occupational health or safety problems 
addressed in the proposal for the agricultural workplace and among 
agricultural populations in the region.

o  Likelihood of developing technical knowledge for the prevention of 
agricultural occupational safety and health hazards on a national or regional 
basis (multi-state).

AWARD CONSIDERATIONS

Applications will be considered for award based upon (a) scientific and 
technical merit, (b) program importance, (c) program balance and geographic 
balance (including multi-state involvement), and (d) availability of funds.

SCHEDULE

Letter of Intent Receipt Date:  February 16, 2001
Application Receipt Date:       March 28, 2001
Anticipated Award Date:         September 1, 2001

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.  The 
opportunity to clarify any issues or questions from potential applicants is 
welcome.

Direct inquiries regarding programmatic issues to either:

Roy M. Fleming, Sc.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-30
Atlanta, GA  30333
Telephone:  (404) 639-3343
FAX:  (404) 639-4616
Email:  [email protected]

Stephen Olenchock, Ph.D.
Agriculture Coordinator
National Institute for Occupational Safety and Health

1095 Willowdale Road, P04/1119
Morgantown, WV 26505-2888
Telephone:  (304) 285-6271
FAX:  (304) 285-6075
Email: [email protected]

Direct inquiries regarding grants management to:

Sheryl L. Heard, Grants Management Specialist
Grants Management Branch, Procurement and Grants Office
Centers for Disease Control and Prevention 
2920 Brandywine Road, Room 3000
Atlanta, Georgia 30341
Telephone: (770) 488-2723
Email: [email protected]

PAPERWORK REDUCTION ACT

Projects that involve the collection of information from 10 or more 
individuals and funded by cooperative agreement will be subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction Act.

AUTHORITY AND REGULATIONS

The Catalog of Federal Domestic Assistance number is: 93.262 for the National 
Institute for Occupational Safety and Health (NIOSH).  This program is 
authorized under the Public Health Service Act, as amended, Section 301(a) [42 
U.S.C. 241(a)], and the Occupational Safety and Health Act of 1970, Section 
20(a) [29 U.S.C. 669(a)].  The applicable program regulation is 42 CFR Part 
52.

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 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.

SMOKE-FREE WORKPLACE

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

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.

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NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
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