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 https://grants.nih.gov/archive/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: https://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:
https://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: achildress@cdc.gov
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: solenchock@cdc.gov
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: gcattledge@cdc.gov
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: lguess@cdc.gov
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: gcattledge@cdc.gov
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 https://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. 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:
https://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:
https://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: gcattledge@cdc.gov
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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html)
a complete copy of the updated Guidelines are available at
https://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
https://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 https://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 https://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
https://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 https://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.