CENTERS FOR AGRICULTURAL DISEASE AND INJURY RESEARCH, EDUCATION AND PREVENTION

RELEASE DATE:  April 3, 2003 

RFA:  OH-03-002 (This RFA has been modified, see PAR-06-057)

National Institute for Occupational Safety and Health, (NIOSH),
Centers for Disease Control and Prevention (CDC),
Department of Health and Human Services (DHHS)
 (http://www.cdc.gov/niosh/homepage.html)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  CFDA 93.956

LETTER OF INTENT RECEIPT DATE: May 20, 2003

APPLICATION RECEIPT DATE: June 12, 2003

EXPIRATION DATE: June 13, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the RFA
o Program Objectives
o Mechanism(s)of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Pre-Application Conference Call
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THE RFA

The National Institute for Occupational Safety and Health (NIOSH/CDC), 
Centers for Disease Control and Prevention (CDC), announces the 
availability of fiscal year (FY) 2003 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 (Agricultural Centers).  The 
purposes of the Agricultural Centers are to conduct 
prevention/intervention, education/outreach, and research programs that 
address agricultural safety and health problems in the geographic 
region served (multi-state), as well as nationally.  

The mission of NIOSH/CDC 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/CDC to lead 
a national effort in surveillance, research, intervention/prevention, 
education, and outreach.  This program has had a significant and 
measurable impact on reducing adverse health effects among agricultural 
workers.  As part of this program, ten Agricultural Centers were 
established nationally.  These Agricultural Centers conduct outreach, 
prevention/intervention, education, and research projects to address 
the nation's pressing agricultural safety and health problems.  
Geographically, the Agricultural 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 
Agricultural Centers help to ensure that actions to prevent disease and 
injury in agriculture are taken based upon scientific findings.  
Additional information on NIOSH/CDC Agricultural Health and Safety 
activities can be found on the NIOSH web site at 
http://www.cdc.gov/niosh/topics/agriculture/default.html.

PROGRAM 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 Agricultural 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 accidental 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. Each day 
approximately 500 agricultural workers suffer lost-work-time injuries, 
and about 5% of these result in permanent impairment. 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 silos, power lines, manure pits, 
and livestock are among the many hazards workers are exposed to in 
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 outreach, prevention/intervention, education, and research 
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 prevention/intervention, 
outreach, education, and research. 

Goals

Note, for this RFA the term "projects" is defined as 
prevention/intervention, education/outreach, or research 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 Agricultural 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 Agricultural Centers should be on addressing 
priority, regional (multi-state) occupational health and safety issues 
including emerging issues applicable to agricultural safety and health 
(such as new technologies, stress, depression, and others), using a 
multi-disciplinary approach.  Emphasis should also be given to 
underrepresented populations 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. 

In 1996, a National Occupational Research Agenda (NORA) was created to 
guide NIOSH.  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/
 
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 
Agricultural Center, applicants are encouraged to consult with regional 
(multi-state) stakeholders (e.g. agricultural organizations, advisory 
groups, workers, and other interested parties).

Agricultural Centers should include the development, implementation, 
and evaluation of model intervention, education, and outreach programs 
that promote 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 to reach the identified agricultural populations within 
the Agricultural Center Districts.  Emphasis should be given to 
reaching under served agricultural populations such as hired farm 
laborers, migrant/seasonal workers, women, and children.

Agricultural 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.

Agricultural Centers should include plans to develop linkages and 
communication with other governmental and non-governmental agencies 
involved in agricultural health and safety, with special emphasis on 
communications and collaborations with other NIOSH/CDC-sponsored 
agricultural health and safety programs.  Refer to the following web 
sites for more information; 
http://www.cdc.gov/niosh/topics/agriculture/default.html and 
http://www.cdc.gov/niosh/agctrhom.html.

Useful References

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

The NIOSH/CDC 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/CDC 
Agricultural Coordinator (name and contact information in the Inquiries 
Section).

MECHANISM(s) OF SUPPORT

This RFA will use NIOSH (U50) cooperative agreement award mechanism.  
As an applicant you will be solely responsible for planning, directing, 
and executing the proposed project. This RFA is a one-time 
solicitation. The anticipated award date is September 1, 2003 and will 
be made for a 12-month budget period.  Continuation awards within the 
project period will be made on the basis of satisfactory progress and 
availability of funds.  Applications that are not funded in the 
competition described in this RFA may be submitted as NEW investigator-
initiated applications using the standard receipt dates for NEW 
applications described in the instructions on the PHS 398 application.

This RFA uses just-in-time concepts and requires the detailed budget 
format, rather than the modular grant budget format. This program does not 
require cost sharing as defined in the current NIH Grants Policy Statement 
at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

The NIOSH (U50)is a cooperative agreement award mechanism in which the 
Principal Investigator retains the primary responsibility and dominant 
role for planning, directing, and executing the proposed project, with 
NIOSH/CDC staff being substantially involved as a partner with the 
Principal Investigator, as described under the section "Cooperative 
Agreement Terms and Conditions of Award".

FUNDS AVAILABLE

NIOSH intends to commit approximately $1,000,000 in FY 2003 to fund 1 
to 2 awards.  An applicant may request a project period not to exceed 
three (3) years and a budget of up to $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, the program merit as judged by a peer-review 
evaluation, and the 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 
Agricultural 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 Agricultural 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.

ELIGIBLE INSTITUTIONS

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

o Domestic public or private universities.
o Domestic for-profit or non-profit medical centers

Foreign institutions are not eligible to apply.

The restriction of eligible applicants is due to the 1990 
appropriations language which initiated this program and states that 
centers for agricultural occupational safety and health will be 
established at universities.

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

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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

Note: Title 2 United States Code section 1611 states that an 
organization described in section 501(c)(4) of the Internal Revenue 
Code that engages in lobbying activities is not eligible to receive 
Federal funds constituting an award, grant, or loan.

SPECIAL REQUIREMENTS

The essential characteristics of an Agricultural Center cooperative 
agreement are:

Overall Characteristics

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

1. Administrative and Planning Core.  
This component should not exceed 20% of the direct cost budget.
2. Prevention/Intervention Core.  
This component should be at least 20% of the direct cost budget.
3. Education and Outreach Core.  
This component should be at least 20% of the direct cost budget.
4. Multi-Disciplinary Research Core.  
This component should be at least 20% of the direct cost budget.

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

o The Agricultural Center's program should be more than a collection of 
projects, but rather should include a process for the administrative 
integration and oversight of the projects.  The projects should address 
agricultural issues in an integrated manner with well defined goals 
that contribute to the overall focus of the Center.  Therefore, under 
the Heading "OVERALL DESCRIPTION", the principal investigator should 
clearly describe the theme of the Center, how projects address the 
Center's focus, and how the Center will function as an integrated 
program rather than simply a collection of projects.   

NON-ALLOWABLE COSTS FOR NIOSH/CDC AGRICULTURAL CENTER COOPERATIVE AGREEMENT

The Agricultural Center funding mechanism should not be used as a 
substitute for individual research grant support.  It is expected that 
investigators participating in Agricultural Centers will have a history 
of independent project support in addition to the Agricultural 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 Agricultural Center cooperative agreement.

ESSENTIAL ELEMENTS OF AN AGRICULTURAL CENTER 

ADMINISTRATIVE AND PLANNING CORE 
(SHOULD NOT EXCEED 20% OF THE ANNUAL DIRECT COST)

The Administrative and Planning Core must have strong leaders committed 
to the program, who are capable of providing scientific leadership and 
willing to accept responsibility for the administration and integration 
of the program.  Assessment of the ability of the program's principal 
investigator to lead a highly integrated program of collaborative 
prevention/intervention, education, outreach, and research projects 
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 conducting 
intervention/prevention, education/outreach, training, and research 
activities such as seminars, workshops, reference collection, computer 
support, etc.  The principal investigator should provide a minimum of 
30% time commitment (direct and in-kind) and each member of the 
internal advisory committee (one prevention/intervention, 
education/outreach, and research project investigator) should provide a 
minimum of 5% time commitment for the Agricultural Center's 
administration and coordination. 

o  Feasibility Projects. Support of feasibility projects in the 
prevention/intervention, education/outreach, and research project areas 
within the NIOSH/CDC Agricultural Center is considered fundamental to 
sustaining the quality, breadth, and dynamics of this program.  These 
projects encourage exploration and development of new and creative 
prevention/intervention, education/outreach, and research approaches, 
and are considered an important and integral part of the support 
provided to the Agricultural Center. Therefore, funds should be 
designated to provide support for short-term projects (maximum duration 
of 12 months and $15,000) to explore the feasibility of new projects in 
any of the Center's program areas (prevention/intervention, 
education/outreach, and research).  This will also enable investigators 
to collect sufficient data to pursue support through other funding 
mechanisms.  Examples of feasibility projects may include but are not 
limited to: 

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

As a general rule, approximately 5% to 10% of the direct cost budget 
for each year should be allocated to the Feasibility Projects Program 
of a Center.  While the administrative framework for management of the 
Center's Feasibility Projects Program is left to the Center Director's 
discretion, certain minimal requirements must be met.  Management of 
the program must include provisions for:

1.  A mechanism that ensures preparation and appropriate announcement 
of the availability of feasibility project funding.
2.  A mechanism for merit review of feasibility project proposals.  
Copies of all proposals, with documentation of their reviews, relative 
ranking, and final action must be retained by the Center.  These 
records must be available to reviewers in the event of a site visit.
3.  A mechanism to maintain a record of subsequent results of each 
feasibility project study (abstract, RO1/R21 submission, etc.) 
recipient.  This record must be available to reviewers in the event of 
a site visit for competing renewals.  Input by both the Internal 
Advisory Committee and the External Advisory Committee into the 
management of the Feasibility Projects Program is strongly recommended.

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

o  An Internal Advisory Committee is comprised of one senior individual 
from each core area that will assist the principal investigator in 
making scientific and administrative decisions in the operation of the 
program.  These individuals should commit 5% of their effort serving on 
this committee.

o  An External Advisory Committee, comprised of at least three members 
who are recognized leaders in agricultural health and safety and 
regional agricultural experts, will provide overall guidance and advice 
to the principal investigator and program investigators on program 
direction.  If not already included in the Agricultural Center, one 
member should be from the Agriculture Extension community.  

PREVENTION/INTERVENTION CORE (Non-Research)
(SHOULD BE AT LEAST 20% OF THE ANNUAL DIRECT COSTS)

This section is predominantly for non-research projects in prevention 
and/or intervention. Projects related to prevention/intervention 
research should not be included here, but rather in the multi-
disciplinary research projects section below.  Applicants should 
provide model programs in prevention/intervention that address injury 
and illness among people who work on, live, or visit farms.  Prevention 
projects may include but are not limited to actions taken to reduce 
susceptibility or exposure to health problems, to detect and treat 
disease in early stages, or to alleviate the effects of disease and 
injury.  Intervention projects may include but are not limited to 
actions to prevent disease or injury through combinations of techniques 
such as control technologies, exposure guidelines and regulations, 
worker participation programs, and training. 
 
Projects should be designed to involve direct input from agricultural 
stakeholders in addressing national needs and in the implementation of 
relevant and culturally appropriate innovative strategies for meeting 
those needs.  The development of strong partnerships with community 
organizations that can facilitate the identification of project needs 
and culturally appropriate education, 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 a monitoring component to determine the 
success of these techniques and programs.  

Partnerships and collaborative relationships are encouraged among the 
Agricultural Center and NIOSH/CDC intramural programs, other extramural 
partners including NIOSH/CDC Education and Research Centers (ERCs), 
Training Grant (TG) recipients, and other NIOSH/CDC funded agricultural 
programs. A central role of the Agricultural Centers is to provide 
leadership in the evaluation of agricultural injury and disease 
programs implemented by agricultural extension programs, State health 
departments, Federal agencies and others.  Projects that address this 
priority area are particularly encouraged.  The project should 
specifically identify: 

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

EDUCATION AND OUTREACH CORE (Non-Research)
(SHOULD BE AT LEAST 20% OF THE ANNUAL DIRECT COSTS)

This section is predominantly for non-research projects in education 
and/or outreach. Projects related to education/outreach research should 
not be included here, but rather in the multi-disciplinary research 
projects section below. Applicants should include well developed 
education and outreach projects to target the key agricultural health 
and safety needs in the Agricultural Center region. These programs 
should be model educational and outreach projects on safety and health 
for workers in agriculture. This core should include educational 
projects and a monitoring component to determine the success of this 
program as a public education approach to protect people who live, work 
on, or visit farms.  

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

Projects should involve regional agricultural stakeholders in 
addressing educational needs and in the implementation of innovative 
approaches for meeting those needs.  Partnerships and collaborative 
relationships are encouraged between Agricultural Centers and NIOSH/CDC 
intramural programs and other extramural partners including NIOSH/CDC 
Education and Research Centers (ERCs), Training Grant (TG) recipients, 
and other NIOSH/CDC funded agricultural programs.  In addition, when 
possible, collaborations with Agriculture Extension Services are 
encouraged. 

MULTI-DISCIPLINARY RESEARCH CORE
(SHOULD BE AT LEAST 20% OF THE ANNUAL DIRECT COSTS)

Two types of projects, pilot(2 years) and integral (up to 3 
years)research projects, will be supported as part of the Agricultural 
Center's program, and both types are encouraged.  Each project (pilot 
and integral research) should be an important component of the Center's 
program.  These projects can be in any of the program areas, outreach, 
prevention, intervention, education, or exploratory, but for this core, 
must be research in nature. Non-research projects in these areas should 
be included in the relevant non-research core.  To be funded, an 
Agricultural Center must have one pilot project and one integral 
research project that are judged to have significant and substantial 
scientific merit.  Collaborative research is encouraged between 
Agricultural Centers and the NIOSH/CDC intramural program.   

Pilot research projects are intended to provide Agricultural Center 
investigators an opportunity to obtain the preliminary research data 
needed to help direct and maintain ongoing prevention/intervention 
education, and research programs and for the submission of a NIOSH/CDC, 
NIH, EPA, or other peer-reviewed Research Project Grant application.  
The maximum project period for a pilot project is 2 years.  Follow the 
instructions for a NIOSH/CDC Exploratory/Developmental (R21)grant (see NIH 
guide: http://grants.nih.gov/grants/guide/rfa-files/RFA-OH-00-006.html), 
for additional information on R21 applications. 

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

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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.

Direct your questions about scientific/research issues to:

Adele Childress, Ph.D., MSPH
Scientific Program Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health/CDC
1600 Clifton Road, N.E.
Building 24, Room 1427, MS E-74
Atlanta, GA  30333
Telephone:  (404) 498-2509
FAX:  (404) 498-2517
Email:  [email protected]

Direct your questions about agricultural program issues to:
 
Stephen Olenchock, Ph.D.
Agriculture Coordinator
National Institute for Occupational Safety and Health/CDC
1095 Willowdale Road, P04/1119
Morgantown, WV 26505-2888
Telephone:  (304) 285-6271
FAX:  (304) 285-6075
Email:  [email protected]

Direct your questions about peer review issues to:

Cattledge, Gwen, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health/CDC
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 24, Room 1423, MS E-74
Atlanta, GA  30333
Telephone:  (404) 498-2508
Fax:  (404) 498-2571
Email:  [email protected]

Direct your questions about financial or grants management matters to:

Larry Guess
Acting Chief
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention 
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Announcement Number OH-03-002
Telephone:  (412) 386-6826
Email:  [email protected]

PRE-APPLICATION CONFERENCE CALL

Applicants are invited by NIOSH/CDC to participate in a pre-application 
technical assistance telephone conference call on May 7, 2003 at 1:OO 
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 404-639-3277 [(800-311-3437), for Non-Federal 
Participants].  Interested parties will need the conference code 
(457136) to participate.

LETTER OF INTENT

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

o Descriptive title of the proposed program
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA

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

The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to: 

Cattledge, Gwen, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health/CDC
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 24, Room 1423, MS E-74
Atlanta, GA  30333
Telephone:  (404) 498-2508
Fax:  (404) 498-2571
Email:  [email protected]

SUBMITTING AN APPLICATION   

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

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html 
in an interactive format. For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email: [email protected].  Information to 
prepare a detailed budget is provided in the instructions.  If the 
proposed project involves organizations or persons other than those 
affiliated with the applicant organization, letters of support and/or 
cooperation must be included. 

SUPPLEMENTAL INSTRUCTIONS

Applications may contain both non-research and research projects in 
either one or several of the Center's program areas (prevention, 
intervention, outreach, education). 

Non Research Projects

Each project section should begin with a cover sheet that identifies it 
as the beginning of the project section (outreach, prevention, 
intervention, and/or education), and the name of a project investigator 
who will be a member of the internal advisory committee should be 
listed.  This page is then followed by as many subsections as there are 
projects under that area.  Each subsection begins with a header page 
that identifies the project investigator and title of the project. The 
next page is the form page 2 of the PHS 398 which provides the 
description, performance sites, and key personnel. For further 
instructions, refer to the TABLE OF CONTENTS FOR THE "CENTERS FOR 
AGRICULTURAL DISEASE AND INJURY RESEARCH, EDUCATION, AND PREVENTION", 
provided below.

PHS 398 form page 3 contains the section entitled "Research Plan" and 
although these projects are not research, this section can be used to 
describe the specific aims, background and significance, preliminary 
information or data, the project design and methods, for each non-
research project (outreach, prevention, intervention, or education).  
This section should contain sufficient information to address the 
projects goals and plan to achieve those goals, it should answer the 
following questions; 1)What do you intend to do?, 2)Why is the work 
important?, 3)What has already been done?, and 4)How are you going to 
do the work?  This section should not exceed 25 pages for items d-g for 
outreach, prevention, intervention, and education project plans

Research Projects

All research projects (outreach, prevention, intervention, and/or 
education), integral or pilot, should be consistent with the 
competitive/peer-reviewed funding applications that are typically 
awarded by NIOSH/CDC and NIH and adhere to the submission guidelines 
for a R01/R21 application following the PHS 398 application 
instructions.  The R01 is a competitive, standard applied or basic 
research project funding mechanism and the R21 is an 
exploratory/developmental funding mechanism which provides small short-
term awards used to explore the feasibility of an innovative basic or 
applied research question or approach. 

Each project section should begin with a cover sheet that identifies it 
as the beginning of the project section (pilot or integral research), 
and the name of a project investigator who will be a member of the 
internal advisory committee should be listed.  This page is then 
followed by as many subsections as there are research projects under 
that area.  Each subsection begins with a header page that identifies 
the project investigator and title of the project. The next page is the 
form page 2 of the PHS 398 which provides the description, performance 
sites, and key personnel.  For further instructions refer to the, Table 
of Contents for an Agricultural Center Application, provided below.

PHS 398 form page 3 contains the section entitled "Research Plan" and 
can be used to describe the specific aims, background and significance, 
preliminary data, the research project design and methods, for each 
research project (outreach, prevention, intervention, or education).

For the integral (R01-type) research projects, the application should 
not exceed 25 pages for items d - g for outreach, prevention, 
intervention, or education project plans(see the, Table of Contents for 
an Agricultural Center Application).  For pilot research (R21-type) 
projects, follow the instructions for a NIOSH/CDC 
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. A 15 page maximum for items 
d - g should be followed. Refer to the, Table of Contents for an 
Agricultural Center Application, provided below.

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

NOTE:  NIOSH/CDC will inform successful applicants of the procedures 
for adding prevention/intervention, education, pilot, or research 
projects in future years of support.  Thus, the application should 
contain only projects for which funds are requested for support during 
year one.

TABLE OF CONTENTS FOR AN AGRICULTURAL CENTER APPLICATION

In order to facilitate the preparation and review of the Agricultural 
Center application, the following Table of Contents should be used.  It 
is a minor modification of the PHS 398 Table of Contents which should 
be followed as a guide.

o Face Page 
o Agricultural Center Description, Performance Sites, and Personnel, 
Form page 2(use additional continuation pages as needed)
o Table of Contents 
o Detailed Budget for the Initial Budget Period for the entire 
Agricultural Center
o Budget for the Entire Proposed Period of Support for the Entire 
Agricultural Center
o Detailed Budget for each Project for the Initial Budget Period 
Organized by Cores (prevention/intervention, educational/outreach, 
research),
o Budget for the Entire Proposed Period for each Project Organized by 
Cores
o Biographical Sketch-Principal Investigator/Program Director
o Other Biographical Sketches
o Other Support
o Overall Description of the Agricultural Center (2 page maximum)
o Past Performance/Accomplishments in Last Project Period (existing 
Agricultural Center)
o Past Performance/Accomplishments Relevant to Agricultural Center 
goals (new applicants)
o Statement on the Institutional Commitment to the Agricultural Center 
(1 page maximum)
o Identification of the States that will be involved with the project
o Administrative and Planning Core Cover Sheet
o Administrative and Planning Core
o Prevention/Intervention Core Cover Sheet
o Prevention/Intervention Project Plan A (use as many headings as there 
are projects)  
o Education and Outreach Core Cover Sheet 
o Education and Outreach Project Plan A (use as many headings as there 
are projects) 
o Research Core Cover Sheet 
o Pilot Project Plan A (use as many headings as there are projects)
o Research Project Plan A (use as many headings as there are projects) 

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 2)
c.  Highlights of Accomplishments for Past Project Period if it was 
part of an existing Agricultural Center (1 page maximum)
d.  Specific Aims
e.  Background and Significance
f.  Preliminary Studies/Progress Report
g.  Project 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/Contractual Arrangements
l.  Consultants and Collaborators, including NIOSH/CDC

Note: Type density and size of the entire application must conform to 
the limits provided on page 3 in the PHS 398 instructions. 

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  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 RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
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:

Cattledge, Gwen, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health/CDC
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 24, Room 1423, MS E-74
Atlanta, GA  30333
Telephone: (404) 498-2508
Fax: (404) 498-2571
Email: [email protected]

APPLICATION PROCESSING: Applications must be received by the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review.  

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

The Center for Scientific 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.  However, when a previously unfunded application, 
originally submitted as an investigator-initiated application, is to be 
submitted in response to this RFA, it is to be prepared as a NEW 
application.  That is the application for the RFA must not include an 
Introduction describing the changes and improvements made, and the text 
must not be marked to indicate the changes. While the investigator may 
still benefit from the previous review, the RFA application is not to 
state explicitly how.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by NIOSH/CDC.  Incomplete applications will be returned 
to the applicant without further consideration. 

Applications that are complete and responsive to the RFA will be 
evaluated for merit by a review group convened by NIOSH/CDC in 
accordance with the review criteria stated below. As part of the 
initial merit review, all applications will:

o Receive a written critique
o Undergo a process in which only those applicants deemed to have the 
highest merit, generally the top half of the applications under review, 
will be discussed and assigned a priority score
o Receive a second level of review by the NIOSH/CDC Secondary Review 
Committee.

REVIEW CRITERIA

The primary consideration for a Center cooperative agreement 
application is the ability of the Center's program to bring together 
quality prevention/intervention, education, outreach, and research 
activities into an interactive, multi-disciplinary operation addressing 
agricultural issues in the region.

SITE VISITS

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

A site visit is not a prerequisite and is not assured for consideration 
of an application by NIOSH/CDC.  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.

General Review Criteria

The criteria that NIOSH/CDC will use to review applications for merit 
and for meeting program objectives are provided below.  In the written 
comments, reviewers will be asked to discuss the following aspects of 
your application in order to judge the likelihood that the proposed 
project (non-research or research) will have a substantial impact on 
the pursuit of these goals:

o Significance
o Approach
o Innovation
o Investigator
o Environment

The review group will address and consider each of these criteria in 
assigning your application's overall score, weighting them as 
appropriate for each application.  Your application does not need to be 
strong in all categories to be judged likely to have a major impact and 
thus deserve a high priority score.  For example you may propose to 
carry out important work that by its nature is not innovative but 
essential to move a field forward.

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 designs addresses the distinct 
characteristics, specific populations, and needs in agricultural 
research and education for the region. 

o  Qualifications of core investigators 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 Prevention/Intervention Core (predominantly Non-
Research) Projects Are:

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

o  APPROACH: Demonstration within the proposed project plan of current 
knowledge of intervention practices and effectiveness.  Does the 
applicant acknowledge potential problem areas and consider alternative 
approaches? Development of activities, plans, and including a  
monitoring component to determine the success of these programs.  Plans 
for the distribution of results and products. 

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?  The project does not have to be innovative but can use 
established methods to have a major impact and thus deserve a high 
priority score.

o  INVESTIGATOR: Qualifications and experience of the principal 
investigator and staff, particularly but not exclusively in areas 
relevant to the NIOSH/CDC's mission of an Agricultural 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  ENVIRONMENT: Availability of resources necessary to perform project 
objectives.  Strength of commitment by the participating institution(s) 
as evidenced by provisions of appropriate resources, services, and 
technical support.

Review Criteria for Education and Outreach Core (predominantly Non-
Research) Projects Are:

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

o  APPROACH: Demonstration within the proposed project plan of current 
knowledge of education practices, outcomes, and standards, specifically 
those related to learning, attitudes, motivation, and educational 
approaches.  Development of activities, plans, and including a 
monitoring component to determine the success of these programs.  Plans 
for the distribution of results and products within the community and 
educational settings.  

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?  The project does not have to be innovative but can use 
established methods to have a major impact and thus deserve a high 
priority score.

o  INVESTIGATOR: Qualifications and education experience of the 
principal investigator and staff, particularly but not exclusively in 
areas relevant to the mission of NIOSH/CDC Agricultural 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 and outreach settings.

o  ENVIRONMENT: Availability of resources necessary to perform project 
objectives. Strength of commitment by the participating institution(s) 
as evidenced by provision of appropriate resources, services, technical 
support.

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 announcement?  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 approaches?

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? The project does not have to be innovative but can use 
established methods to have a major impact and thus deserve a high 
priority score.

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?

ADDITIONAL REVIEW CRITERIA FOR ALL PROJECTS (Non-Research and 
Research): In addition to the above criteria, the following items will 
be considered in the determination of scientific merit and the priority 
score:

o PROTECTIONS OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below).

o INCLUSIONS OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The 
adequacy of plans to include subject from both genders, all racial and 
ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
in the sections on Federal Citations, below). 

o CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001 
will be assessed).

ADDITIONAL CONSIDERATIONS     

o BUDGET: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.  

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 knowledge (in the areas of science, 
education, prevention, intervention, or outreach) for the prevention of 
agricultural occupational safety and health hazards on a National or 
regional basis (multi-state).

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: May 20, 2003
Application Receipt Date: June 12, 2003
Anticipated Award Date: September 1, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Program merit
o Availability of funds
o Programmatic priorities
o Balance of program areas and geographic balance (including multi-
state involvement).

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

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

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

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

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

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

2.  NIOSH/CDC 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 NIOSH/CDC 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/CDC 
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 Agricultural Centers Methods 
Committee.  This multi-site committee will provide a means to 
standardize the collection of evaluation materials/information across 
Agricultural Centers.  It will also provide a means to collect 
information necessary to help address accomplishments on the NIOSH/CDC 
Agricultural Initiative.  Information and materials may be collected at 
one repository location for common use by all the Centers.  If there 
are added costs associated with creating and maintaining this 
repository, NIOSH/CDC 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/CDC to achieve a more 
integrated and effective program in agricultural health and safety.

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated 
with reference to the risks to the subjects, the adequacy of protection 
against these risks, the potential benefits of the research to the 
subjects and others, and the importance of the knowledge gained or to 
be gained.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the 
policy of the CDC that women and members of minority groups and their 
sub-populations must be included in all CDC-supported clinical research 
projects unless a clear and compelling justification is provided 
indicating that inclusion is inappropriate with respect to the health 
of the subjects or the purpose of the research. This policy results 
from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH 
Guidelines For Inclusion of Women and Minorities as Subjects in 
Clinical Research, - amended, October, 2001," published in the NIH 
Guide for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html)
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_
2001.htm.  The amended policy incorporates: the use of an NIH definition 
of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of CDC staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS:  The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 
1998.  This policy will be followed by NIOSH for this announcement. 

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects" that is available at 
http://grants.nih.gov/grants/funding/children/children.html

HUMAN SUBJECT REGUIREMENTS: If the proposed project involves research 
on human subjects, the applicant must comply with the Department of 
Health and Human Services (DHHS) Regulations (Title 45 Code of Federal 
Regulations Part 46) regarding the protection of human research 
subjects.  All awardees of CDC grants and cooperative agreements and 
their performances sites engaged in human subjects research are 
strongly recommended to file an assurance of compliance with the 
regulations and have continuing reviews of the research protocol by 
appropriate institutional review boards.

In order to obtain a federal-wide Assurance (FWA) of Protection for 
Human Subjects, the applicant can complete an on-line application at 
the Office for Human Research Protections (OHRP) website or write to 
the OHRP for an application.  OHRP will verify that the signatory 
official and the Human Subjects Protections Administrator have 
completed the OHRP Assurance Training/Education Module before approving 
the FWA.  Existing Multiple Project Assurances (MPAs), Cooperative 
Project Assurances (CPAs), and Single Project Assurances (SPAs) remain 
in full effect until they expire or until December 31, 2003, whichever 
comes first.

To obtain a FWA contact the OHRP at: 
http://www.hhs.gov/ohrp/assurances/assurances_index.html or write to:
Office for Human Research Protections (OHRP)
Department of Health and Human Services
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852

Note: In addition to other applicable committees, Indian Health Service 
(IHS) institutional review committees must also 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 the applicable portion of that project.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-00-039.html. This policy will be followed by NIOSH for 
this announcement.

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).  Web 
page http://grants.nih.gov/grants/olaw/olaw.htm

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  
The Department of Health and Human Services (DHHS) issued final 
modification to the "Standards for Privacy of Individually Identifiable 
Health Information", the "Privacy Rule," on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR). 
Those who must comply with the Privacy Rule (classified under the Rule 
as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

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

URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for 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.  Furthermore, we caution reviewers that their 
anonymity may be compromised when they directly access an Internet 
site.

LOBBYING RESTRICTIONS: Applicants should be aware of restrictions on 
the use of Health and Human Services (DHHS) funds for lobbying of 
Federal or State legislative bodies.  Under the provisions of 31 U.S.C. 
Section 1352, recipients (and their subtier contractors) are prohibited 
from using appropriated Federal funds (other than profits from a 
Federal contract) for lobbying congress or any Federal agency in 
connection with the award of a particular contract, grant, cooperative 
agreement, or loan.  This includes grants/cooperative agreements that, 
in whole or in part, involve conferences for which Federal funds cannot 
be used directly or indirectly to encourage participants to lobby or to 
instruct participants on how to lobby.

In addition, no part of the Centers for Disease Control and Prevention 
(CDC) appropriated funds shall be used, other than for normal and 
recognized executive-legislative relationships, for publicity or 
propaganda purposes, for the preparation, distribution, or use of any 
kit, pamphlet, booklet, publication, radio, television, or video 
presentation designed to support or defeat legislation pending before 
the Congress or any State or local legislature, except in presentation 
to the Congress or any State or local legislature itself.  No part of 
the appropriated funds shall be used to pay the salary or expenses of 
any grant or contract recipient, or agent acting for such recipient, 
related to any activity designed to influence legislation or 
appropriations pending before the Congress or any State or local 
legislature.

Any activity designed to influence action in regard to a particular 
piece of pending legislation would be considered "lobbying."  That is 
lobbying for or against pending legislation, as well as indirect or 
"grass roots: lobbying efforts by award recipients that are directed at 
inducing members of the public to contact their elected representatives 
at the Federal or State levels to urge support of, or opposition to, 
pending legislative proposals is prohibited.  As a matter of policy, 
CDC extends the prohibitions to lobbying with respect to local 
legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the 
legislative branch, or to prohibit educational efforts pertaining to 
public health.  Clearly there are circumstances when it is advisable 
and permissible to provide information to the legislative branch in 
order to foster implementation of prevention strategies to promote 
public health.  However, it would not be permissible to influence, 
directly or indirectly, a specific piece of pending legislation.

It remains permissible to use CDC funds to engage in activity to 
enhance prevention; collect and analyze data; publish and disseminate 
results of research and surveillance data; implement prevention 
strategies; conduct community outreach services; provide leadership and 
training; and foster safe and healthful environments.

Recipients of CDC grants and cooperative agreements need to be careful 
to prevent CDC funds from being used to influence or promote pending 
legislation.  With respect to conferences, public events, publication, 
and "grassroots" activities that relate to specific legislation, 
recipients of CDC funds should give attention to isolating and 
separating the appropriate use of CDC funds from non-CDC funds.  CDC 
also cautions recipients of CDC funds to be careful not to give the 
appearance that CDC funds are being used to carry out activities in a 
manner that is prohibited under Federal law.

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 Program Announcement 
is certifying compliance with the Department of Health and Human 
Services (DHHS) regulations in Title 42 Part 50, Subpart A, entitled 
"Responsibility of PHS Awardee and Applicant Institutions for Dealing 
with and Reporting Possible Misconduct in Science."
The regulation places several requirements on institutions receiving or 
applying for funds under the PHS Act that are monitored by the DHHS 
Office of Research Integrity's (ORI) Assurance Program. 
For examples:
Section 50.103(a) of the regulation states: "Each institution that 
applies for or receives assistance under the Act for any project or 
program which involves the conduct of biomedical or behavioral research 
must have an assurance satisfactory to the Secretary (DHHS) that the 
applicant: (1) Has established an administrative process, that meets 
the requirements of this subpart, for reviewing, investigating, and 
reporting allegations of misconduct in science in connection with PHS-
sponsored biomedical and behavioral research conducted at the applicant 
institution or sponsored by the applicant; and (2) Will comply with its 
own administrative process and the requirements of this Subpart."
Section 50.103(b) of the regulation states that: "an applicant or 
recipient institution shall make an annual submission to the [ORI] as 
follows: (1) The institution's assurance shall be submitted to the 
[ORI], on a form prescribed by the Secretary,...and updated annually 
thereafter...(2) An institution shall submit, along with its annual 
assurance, such aggregate information on allegations, inquiries, and 
investigations as the Secretary may prescribe." 

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 RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 301(a) [42 U.S.C. 241(a)], the Occupational 
Safety and Health Act of 1970, Section 20(a) [29 U.S.C. 669(a)] 
[number: 93.956, Agricultural Health and Safety Program of the National 
Institute for Occupational Safety and Health (NIOSH)], and under 
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

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

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