NIH Guide: NATIONAL CENTER FOR CHILDHOOD AGRICULTURAL INJURY PREVENTION

NATIONAL CENTER FOR CHILDHOOD AGRICULTURAL INJURY PREVENTION

RELEASE DATE: April 3, 2003

RFA: OH-03-001

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

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 THIS RFA

Centers for Disease Control and Prevention (CDC), National Institute for
Occupational Safety and Health (NIOSH), announces the availability of funds
in fiscal year 2003 to support a National Center for Childhood Agricultural
Injury Prevention. The purpose of this program is to provide support for a
national center for the prevention of childhood agricultural injury that 1)
serves as a leader to facilitates prevention efforts and activities; 2)
provide or enhance efforts to prevent injuries occurring to children who live
on, work on, or visit farms, or are associated with other agricultural
activities that pose a risk to children; 3) establish linkages and
partnerships with the agricultural community to facilitate childhood
agricultural injury prevention; 4) identifies, disseminates, and facilitates
the use of state-of-the-art information and programs to prevent childhood
agricultural injuries; 5) provide recommendations, utilizing input from the
diverse stakeholders within childhood agricultural safety and health, for
guiding childhood agricultural injury prevention efforts; and 6) conduct
research to improve the safety and health of children who live on, work on,
or visit farms.

This announcement identifies program needs consistent with the National
Occupational Research Agenda (NORA) developed by NIOSH and partners in the
public and private sectors to provide a framework to guide occupational
safety and health research in the new millennium towards topics which are
most pressing and most likely to yield gains to the worker and the nation.
The agenda identifies 21 research priorities. NORA priorities with specific
relevance to this announcement are: traumatic injuries and special
populations at risk, however, other relevant NORA priority areas are
considered. Information about NORA is available through the NIOSH Home Page;
http://www.cdc.gov/niosh/nora/.

PROGRAM OBJECTIVES

Background

Agricultural production, which is most commonly identified with the
occupation of farming, consistently ranks among the United States industries
with the highest rates of work-related injuries and deaths, and is unique
with respect to children and adolescents. Agriculture is the only major
industry in which the workplace often encompasses the home. Exposures to
agricultural production hazards are not confined to working adults. Children
and adolescents may be exposed to agricultural production hazards not only
through work activities, but also by virtue of living on a farm or ranch,
accompanying their parents to work, or visiting farms. Children and
adolescent involvement on farms is unique not only because they often begin
to actively work on the farm at an early age, but because they also live and
undertake recreational activities on the farm. An estimated 1.9 million youth
less than 18 years of age lived or worked on a farm in 1998 (NIOSH pub. 2001-
154).

In April 1996, the National Committee for Childhood Agricultural Injury
Prevention (NCCAIP) published a National Action Plan to maximize the safety
and health of all children and adolescents who may be exposed to agricultural
hazards. The National Action Plan included 13 objectives and 43 recommended
actions that called for funding of research and safety programs by the
Federal government, foundations, agribusiness, and other public and private
sector groups and nonprofit community-based organizations. The National
Action Plan specifically calls for developing collaboration among
researchers, public sector agencies and private sector foundations,
corporations, associations, nonprofit community-based organizations, and
other groups who can enact change; conducting efforts to ensure the public is
aware of childhood agricultural safety and health issues; using consensus-
building processes which involve interdisciplinary experts and stakeholders
to arrive at guidelines and recommended standards for research and practices;
and using state-of-the-art information and materials are essential for
achieving the objectives set forth in this plan.

In 2001, a summit on childhood agricultural injury prevention was convened
with the goal to propose specific injury prevention strategies based on
knowledge gained from research and interventions undertaken since
implementation of the National Action Plan in 1996. Nearly 100 farmers,
growers, professors, physicians, adolescents, and safety professionals, along
with representatives of agricultural organizations and federal agencies,
participated in the process of developing plans for a coordinated,
comprehensive effort to prevent agricultural-related injuries among children
and adolescents who live on, work on, or visit farms. The report, Childhood
Agricultural Injury Prevention: Progress Report and Updated National Action
Plan from the 2001 Summit, was released in April 2002. The Summit report
provides an assessment of progress to date in implementing the National
Action Plan, and includes three primary goals and twelve specific
recommendations to generate strategies and priorities for future efforts
related to childhood agricultural injury prevention. The Summit report
builds upon the 1996 National Action Plan.

Goal

The goal of the National Center for Childhood Agricultural Injury Prevention
will be to enhance the knowledge, attitudes, and practices of individuals,
groups, and community-based organizations to protect children and adolescents
from agricultural injuries.

Useful References

National Committee for Childhood Agricultural Injury Prevention. Children and
Agriculture: Opportunities for Safety and Health. Marshfield, WI: Marshfield
Clinic. 1996. http://research.marshfieldclinic.org/children/action/title.htm

Lee, B. Gallagher, S. Marlenga, B. and Hard, D. (Eds.). 2002. Childhood
Agricultural Injury Prevention: Progress Report and Updated National Action
Plan for the 2001 Summit. Marshfield, WI: Marshfield Clinic.
http://www.marshfieldclinic.org/research/children/childrensReport/.

MECHANISM 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.

This RFA uses just-in-time concepts. This RFA 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/part_i.htm#matchorcost.

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 AVAILABILE

NIOSH intends to commit approximately $800,000 in FY 2003 to fund one award
to support a National Center for Childhood Agricultural Injury Prevention.
The amount of funding available may vary and is subject to change. The award
will be made for a 12-month budget period within a project period not to
exceed 5 years.

Continuation awards within a project period will be made on the basis of
satisfactory progress and the availability of funds.

Use of Funds

Applicants should include in their budget travel funds for one trip per year
for an annual meeting with NIOSH/CDC scientists and other childhood
agricultural principal investigators to be held in Morgantown, West Virginia.

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

The restriction of eligible applicants is due to the 1997 appropriations
language which initiated this program and states that centers for
agricultural occupational safety and health will be established at
universities.

Foreign institutions are not eligible to apply.

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 a National Center for Childhood Agricultural
Injury Prevention program are:

Overall Characteristics

o The National Center for Childhood Agricultural Injury Prevention will
support a broadly based national program of a coordinated outreach,
prevention/intervention, education, and research projects. A National Center
for Childhood Agricultural Injury Prevention is expected to have the
following components which together address the objectives of the Center:

1. Administrative and Planning Core.
This component should not exceed 25% of the direct cost budget.
2. Outreach Core
This component should be at least 10% of the direct cost budget.
3. Prevention/Intervention Core.
This component should be at least 10% of the direct cost budget.
4. Education Core.
This component should be at least 10% of the direct cost budget.
5. Research Core.
This component should be at least 10% of the direct cost budget.

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

o The National Center for Childhood Agricultural Injury Prevention 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 national child 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 a national
integrated program rather than simply a collection of projects.

NON-ALLOWABLE COSTS FOR THE NATIONAL CENTER FOR CHILDHOOD AGRICULTURAL INJURY
PREVENTION PROGRAM

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
National Center for Childhood Agricultural Injury Prevention program.

ESSENTIAL ELEMENTS OF A NATIONAL CENTER FOR CHILDHOOD AGRICULTURAL INJURY
PREVENTION

ADMINISTRATIVE AND PLANNING CORE
(Should not exceed 25% of the annual direct cost)

The Administrative and Planning Core must have strong leaders committed to
the program, who are capable of providing leadership and who are willing to
accept responsibility for the administration and integration of a national
program. Assessment of the ability of the program's principal investigator
to lead a highly integrated program of outreach, prevention/intervention,
education, and research 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 core. The responsibilities and activities for the administrative and
planning core include:

o Appropriate and adequate organization and facilities for conducting
outreach, prevention/intervention, education, training, and research
activities such as seminars, workshops, reference collection, computer
support, etc. The principal investigator should commit a minimum of 30% time
(direct and in-kind) to the effort and each member of the internal advisory
committee (one outreach, prevention/intervention, education, and research
project investigator) should commit a minimum of 5% time for the National
Center's administration and coordination.

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 formed from the individual core area
program leaders, i.e., one each from outreach, prevention/intervention,
education, and research. These individuals will assist the principal
investigator in making programmatic and administrative decisions in the
operation of the overall Center's program and should have a minimum time
commitment of 5%.

o An External Advisory Committee comprised of at least three members who are
recognized leaders in child agriculture safety that will provide overall
guidance and advice to the principal investigator and core program
investigators on program direction. If not already included in the National
Center for Childhood Agricultural Injury Prevention, one external advisory
committee member should be from the Agriculture Extension community.

o Feasibility Projects. Support of feasibility projects in the outreach,
prevention/intervention, education, and research project areas within the
National Center for Childhood Agricultural Injury Prevention is considered
fundamental to sustaining the quality, breadth, and dynamics of this national
injury prevention program. These projects encourage investigations and
development of new and/or creative outreach, prevention/intervention,
education, and research approaches, and are considered an important and
integral part of the support provided to the National Center for Childhood
Agricultural Injury Prevention. 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
core program areas (outreach, prevention/intervention, education, or
research). This will also enable investigators to collect sufficient data to
pursue support through other funding mechanisms. Examples of feasibility
projects include but are not limited to:

1. Provide initial support for new investigators to develop new or
innovative approaches/lines of investigation in any of the four core program
areas.
2. Allow exploration of possible innovative or new directions representing a
significant departure from ongoing funded projects in agricultural sciences
(outreach, prevention/intervention, education, or research).
3. Stimulate investigators from other fields of study to apply their
expertise to child agricultural safety and health issues.

As a general rule, approximately 10%-15% of the direct cost budget for each
year should be allocated to the Feasibility Projects Program of the 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 should be met. Management of the program should include
provision for:

1. A mechanism that ensures preparation and appropriate announcement of the
availability of funding for feasibility projects.
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 should 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 (abstract, RO1/R21 submission, etc.) recipient. This
record should be available to reviewers in the event of a site visit for
competing renewals. Both the Internal Advisory Committee and the External
Advisory Committee are strongly encouraged to provide input into management
of the Feasibility Projects program.

OUTREACH CORE (Non-Research)
(SHOULD BE AT LEAST 10% OF THE ANNUAL DIRECT COST)

This section is predominantly for non-research projects in outreach. Projects
related to outreach research should not be included here, but rather in the
pilot research project section below. The outreach core is an essential
component of the National Center for Childhood Agricultural Injury
Prevention, playing a key role in coalition building among organizations and
groups that have the potential to reduce the childhood agricultural injury
burden. Assessment of the ability of the core leader to develop and lead a
highly integrated collaborative outreach program of prevention/intervention
and educational/training activities will be a significant consideration in
the evaluation of the application. There must also be a demonstrated
commitment of the core leader for consensus development activities aimed at
identifying issues and providing a course of action to reduce childhood
agricultural injuries and engaging the private sector to become an
acknowledged entity in childhood agricultural injury prevention. Annual
meetings to bring these groups (or components of these groups) together to
raise awareness of issues, promote action and achieve a "critical mass" of
dedicated professionals to prevent childhood agricultural injuries are
encouraged.

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 children who live on, work
on, or visit 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
childhood agricultural injuries.

PREVENTION/INTERVENTION CORE (Non-Research)
(SHOULD BE AT LEAST 10% OF THE ANNUAL DIRECT COSTS)

This section is predominantly for non-research projects in
prevention/intervention. Projects related to prevention/intervention research
should not be included here, but rather in the pilot research project section
below. Applicants should provide model programs, including
prevention/intervention projects, for the prevention of injury among children
who live on, work on, or visit farms. Prevention/intervention projects may
include but are not limited to actions to prevent injury through combinations
of techniques such as control technologies, exposure guidelines and
regulations, worker participation programs, and training.

Programs should be designed to involve direct input from national
agricultural stakeholders in addressing national needs and in the
implementation of relevant and culturally appropriate activities for meeting
those needs. The development of strong partnerships with community
organizations that can facilitate the identification of project needs and
culturally appropriate prevention/intervention activities is encouraged.
These programs 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
National Center for Childhood Agricultural Injury Prevention and the
NIOSH/CDC Centers for Agriculture Disease and Injury Research, Education, and
Prevention, NIOSH/CDC intramural programs, other extramural partners
including NIOSH/CDC Education and Research Centers (ERCs), Training Project
Grant (TPG) recipients, and other NIOSH/CDC funded agricultural programs. In
addition, when possible, collaborations with Agricultural Extension units and
Vocational Agricultural Programs are encouraged. In addition to national-
level activities, projects should specifically identify:

o The population of interest and relevant safety and health 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.

EDUCATION CORE (Non-Research)
(SHOULD BE AT LEAST 10% OF THE ANNUAL DIRECT COSTS)

This section is predominantly for non-research projects in education.
Projects related to education research should not be included here, but
rather in the pilot research project section below. Applicants should
include well developed education project plans to target key agricultural
safety and health needs. This Center core should include educational
programs and a monitoring component to determine the success of these
programs as a national public education approach to protect children who live
on, work on, or visit farms. 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 children. These projects
should be coordinated with the outreach core.

Projects should involve agricultural stakeholders in addressing educational
needs and in the implementation of a monitoring component to determine the
success of these projects in meeting those needs. Partnerships and
collaborative relationships are encouraged across states, as well as with the
NIOSH/CDC Centers for Agriculture Disease and Injury Research, Education, and
Prevention, NIOSH/CDC intramural programs, and other extramural partners
including NIOSH/CDC Education and Research Centers (ERCs), Training Project
Grant (TPG) recipients, and other NIOSH/CDC funded agricultural programs. In
addition, when possible, collaborations with Agriculture Extension units and
Vocational Agricultural Programs are encouraged.

RESEARCH CORE
(SHOULD BE AT LEAST 10% OF THE ANNUAL DIRECT COSTS)

Pilot research projects will be supported as part of the National Center for
Childhood Agricultural Injury Prevention program. To be responsive to the
RFA, a minimum of one pilot research project should be proposed. These pilot
research projects can be in any of the core program areas, outreach,
prevention/intervention, or education, but must be research in nature. Non-
research projects in these core areas should be included in the relevant non-
research core.

Pilot (R21-type)research projects are intended to provide the National Center
for Childhood Agricultural Injury Prevention investigators an opportunity to
obtain the preliminary research data needed to help direct and maintain
ongoing outreach, education, or prevention/intervention programs and for the
submission of a CDC, NIH, EPA, or other peer-reviewed research project grant
applications. The maximum project period for a pilot project (R21-type) 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.

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
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
1600 Clifton Road, N.E.
Building 24, Room 1427, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2509
FAX: (404) 498-2571
Email: achildress@cdc.gov

Direct your questions about the NIOSH agricultural program to:

Stephen Olenchock, Ph.D.
Agriculture Coordinator
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
1095 Willowdale Road, P04/1119
Morgantown, WV 26505-2888
Telephone: (304) 285-6271
FAX: (304) 285-6075
Email: solenchock@cdc.gov

Direct your questions about peer review issues to:

Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone: 304-285-5979
Fax: 304-285-6147
Email: pmajor@cdc.gov

Direct questions about financial or grants business 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-03-001
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 6, 2003 at 1:00 PM
(Eastern time) to discuss: programmatic issues, how to apply, and questions
regarding the content of the RFA. The conference name is Child Agriculture
Center program (CACP). The telephone bridge number is (404) 639-4100 (800-
713-1971, for Non-Federal Participants). Interested parties will need the
conference code (233749) 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:

SUBMITTING AN APPLICATION

Although not a prerequisite for applying, applicants are encouraged to
consult with NIOSH/CDC program staff concerning the technical and substantive
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 301/435-0714,
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 must contain both non-research and pilot research projects.
Pilot research projects can be proposed in either one or several of the
Center's core program areas (outreach, prevention/intervention, and/or
education).

Non-Research Core Projects (Outreach, Prevention/Intervention, Education)

Each non-research core project section should begin with a cover sheet that
identifies it as the beginning of the core project section (outreach,
prevention/intervention, 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 NATIONAL CENTER FOR CHILDHOOD AGRICULTURAL INJURY
PREVENTION", provided below.

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

NOTE: NIOSH/CDC will inform successful applicants of the procedures for
adding additional projects in subsequent years of support.

Pilot Research Projects (Outreach, Prevention/Intervention, Education)

Any pilot research project(s)(outreach, prevention/intervention, or
education), 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 R21 application following the PHS 398
application instructions. The R21 is an exploratory/developmental funding
mechanism which provides small short-term (2 year) awards used to explore the
feasibility of an innovative basic or applied research question or approach.
To be responsive to this RFA, a minimum of one pilot research project should
be proposed.

The pilot research core project section should begin with a cover sheet that
identifies it as the beginning of the pilot research core project section,
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 pilot 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.
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 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. For further instructions refer to the "TABLE OF CONTENTS
FOR THE NATIONAL CENTER FOR CHILDHOOD AGRICULTURAL INJURY PREVENTION",
provided below.

NOTE: NIOSH/CDC will inform successful applicants of the procedures for
adding additional projects in subsequent years of support.

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

TABLE OF CONTENTS FOR THE NATIONAL CENTER FOR CHILDHOOD AGRICULTURAL INJURY
PREVENTION

In order to facilitate the preparation and review of the National Center for
Childhood Agricultural Injury Prevention 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 National Center for Childhood Agricultural Injury Prevention 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 National
Center for Childhood Agricultural Injury Prevention.
o Budget for the Entire Proposed Period of Support for the Entire National
Center for Childhood Agricultural Injury Prevention.
o Detailed Budget for each Project for the Initial Budget Period Organized by
Cores.
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 National Center for Childhood Agricultural
Injury Prevention(2 page maximum).
o Highlights of Accomplishments for Past Project Period (for an existing
Child Agricultural Center)(1 page maximum).
o Highlights of Accomplishments Relevant to a National Center for Childhood
Agricultural Injury Prevention Goals (new applicants).
o Statement on the Institutional Commitment to the National Center for
Childhood Agricultural Injury Prevention(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 Outreach Core Cover Sheet.
o Outreach Project Plan A (use as many headings as there are projects).
o Prevention/Intervention Core Cover Sheet.
o Prevention/Intervention Project Plan A (use as many headings as there are
projects).
o Education Core Cover Sheet.
o Education Project Plan A (use as many headings as there are projects).
o Pilot Research Core Cover Sheet.
o Pilot Project Plan A (R21-type)(use as many headings as there are
projects).

Note: each project plan (outreach, prevention/intervention, education, or
research) 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 an existing
NIOSH/CDC Center) (1 page maximum).
Highlights of Accomplishments Relevant to a National Center for Childhood
Agricultural Injury Prevention Goals (new applicants).
d. Specific Aims.
e. Background and Significance.
f. Preliminary Studies/Progress Report.
g. Project Design, Methods, or Approach.

Items d-g cannot exceed 25 pages (except pilot research projects (R21), 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 in the PHS 398 instructions on page 3.

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 be
sent to:

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/CDC 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
program 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 of their peers 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 (SRC).

REVIEW CRITERIA

The primary consideration for a Center application is the ability of the
Center's program to bring together quality outreach, prevention/
intervention, education, and research activities into a national interactive,
multi-disciplinary operation addressing childhood agricultural injury issues
in the nation. Since the programmatic core areas are not mutually exclusive,
applicants will have latitude in determining the most appropriate core
area(s) for each proposed project.

Site Visits

A site visit to 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 Special Emphasis Panel (SEP) who have expertise
in major program 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, new projects, or
investigators, for making major changes, or for delivering another edition of
the application. Rather, it should be used by the principal investigator and
associates to elaborate on the program and core units, cost effectiveness and
quality control features of the core units, and on other Center activities
for which funding is requested. It also serves 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 the 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 the application's overall score, weighting them as appropriate for
each application. The application does not need to be strong in all
categories to be judged likely to have major program impact and thus deserve
a high priority score. For example an investigator may propose to carry out
important work that by its nature is not innovative but essential to move a
field forward.

Review Criteria for the Overall Program Are:

o Responsiveness to the objectives of the RFA, including the applicant's
understanding of the objectives of the national program for preventing
childhood agricultural injuries and the relevance of the proposal to those
objectives.

o Feasibility of meeting the proposed objectives of the RFA and the national
program for preventing childhood agricultural injuries, including the
proposed schedule for initiating and accomplishing each of the activities
within the core areas and the proposed method for evaluating the
accomplishments.

o Degree to which the overall Center's program addresses the distinct
characteristics, specific populations, and needs in childhood agricultural
injury prevention for the nation.

o Qualifications of the technical, physical, and intellectual environment of
key Center staff to serve as a national resource for childhood agricultural
injury prevention efforts.

o National multi-disciplinary scope of the program.

o Degree of interrelationships, collaboration, and synergism of projects
proposed for funding in this RFA.

o Technical stature as well as leadership ability of the Center Director and
his/her ability to meet the program's demands of time and effort.

o Provisions for coordinating the programmatic cores. The applicant must
have appropriate administrative arrangements and facilities that stimulate
collaboration among constituent projects and personnel.

o Effectiveness of the applicant in establishing or continuing an outreach
and education program that makes maximum use of the National Center for
Childhood Agricultural Injury Prevention strengths in educating the public
with regard to preventing or reducing child and adolescent agricultural
injuries and/or hazard exposure.

o Institutional commitment to the National Center for Childhood Agricultural
Injury Prevention

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

o SIGNIFICANCE: Merit and significance of the proposed projects as determined
by such factors as content, originality, feasibility, potential long-term
success, transportability, and appropriateness for 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 and plans, including a monitoring component to
determine the success of these programs as a national public outreach and/or
education approach for prevention/intervention of child and adolescent
agricultural injuries. Plans for the distribution of results and products to
appropriate stakeholders.

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 mission
of the National Center for Childhood Agricultural Injury Prevention.
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 provisions of appropriate resources, services, and technical
support.

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 populations served by the
Center.

o APPROACH: Demonstration within the proposed project plan of current
knowledge of prevention/intervention practices and effectiveness. Does the
applicant acknowledge potential problem areas and consider alternative
approaches? Development of activities and plans, including a monitoring
component to determine the success of these programs in the
prevention/intervention of child and adolescent agricultural injuries. 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.

Review Criteria for Pilot Research Core (Outreach, Prevention/Intervention,
and/or Education) Projects Are:

o SIGNIFICANCE: Does this project address an important problem related to the
research areas outlined in this announcement? If the aims of the application
are achieved, how will scientific knowledge be advanced?

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 technical/scientific environment in which the work
will be performed 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 (Research and Non-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 safety problems addressed in the
proposal for children and adolescents who live on, work on, or visit farms.

o Likelihood of developing knowledge (in the areas of outreach,
prevention/intervention, or education for the prevention of childhood
agricultural injuries.

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) for a National Center for Childhood Agricultural Injury
Prevention.

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 a
complex multidisciplinary project. Because of the nature of this award,
NIOSH/CDC program staff may be more involved than in a usual research grant.
NIOSH/CDC program staff may assist, as appropriate, the recipient's activity
by working with the award recipient, but NIOSH/CDC will not 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, and NIOSH/CDC program
staff will be available to collaborate where appropriate.

In conducting activities to achieve the purpose of this program, the
recipient will be responsible for activities under "Recipient Activities",
and NIOSH/CDC will be responsible for the activities listed under "NIOSH/CDC
Activities".

1. Recipient Activities

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

o Establish and enhance a national Center for programs, research, and
information which have been shown to be effective in preventing childhood
agricultural injuries;

o Establish and maintain contacts with organizations, groups, and
individuals which supply childhood agricultural injury prevention information
and data for use in targeting prevention efforts and prioritizing program
needs;

o Facilitate awareness and utilization of the Center through appropriate
activities, including but not limited to involving minority-serving groups,
community-based organizations, and other relevant organizations;

o Coordinate and collaborate with established and ongoing health
communication efforts, such as the National Safety Council's "Farm Safety and
Health Week," "Farm Safety 4 Just Kids," and other relevant organizations as
appropriate;

o Organize and manage multi-perspective work groups which use consensus-
building processes to arrive at recommendations for the protection of youth
who work on farms and the protection of bystander children who are exposed to
farm hazards.

o Inform and facilitate the involvement of the private sector in childhood
agricultural injury prevention activities;

o Collaborate with public and private sector agencies, community-based
organizations, researchers, and other groups who can enact change through
prevention efforts and activities;

o Conduct pilot research into the causes and prevention of childhood
agricultural injuries;

o Monitor the success of the National Center for the Prevention of Childhood
Agricultural Injury on promoting actions to prevent childhood agricultural
injuries.

2. NIOSH/CDC Activities

NIOSH/CDC recognizes the potential need for assistance, when appropriate, in
such a complex and diverse project. The following types of activities will
be available from NIOSH/CDC program staff:

o Provide technical assistance with program development, implementation,
maintenance, priority setting, evaluation of efforts, enhancement of the
Center, and information and dissemination activities.

o Facilitate linkages with researchers and public and private sector
agencies and organizations to plan, implement, and evaluate childhood
agricultural injury prevention efforts.

o Collaborate with the recipient in joint safety and health research,
communication and dissemination efforts related to childhood agricultural
injury prevention.

o Communicate new findings from NIOSH/CDC supported research.

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.htm.

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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