CHILDHOOD AGRICULTURAL SAFETY AND HEALTH RESEARCH 

RELEASE DATE:  March 20, 2003 

RFA:  OH-03-003 (This RFA has been modified, see RFA-OH-07-002) 

LETTER OF INTENT RECEIPT DATE:  April 18, 2003

APPLICATION RECEIPT DATE:  May 23, 2003

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

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

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the RFA
o Research Objectives
o Mechanism(s)of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
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

The Centers for Disease Control and Prevention (CDC), National Institute for 
Occupational Safety and Health (NIOSH) announces the availability of fiscal 
year (FY) 2003 funds for grant applications for research on childhood 
agricultural safety and health. Projects are sought which will conduct 
research to: (1) develop and evaluate new or existing enhanced control 
technologies to reduce injury to youth exposed to farm hazards, (2) develop 
and evaluate incentives which encourage adults to protect youth from farm 
hazards, or (3) identify the economic and social consequences of youth 
working on farms.  Findings from these projects are intended to advance the 
scientific base of knowledge needed to maximize the safety and health of 
children exposed to agricultural production hazards.

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, special populations 
at risk, intervention effectiveness research, and social and economic 
consequences of workplace illness and injury.  Information about NORA is 
available through the NIOSH Home Page; http://www.cdc.gov/niosh/nora/.

RESEARCH OBJECTIVES

Background

Agricultural production, which commonly encompasses farming, consistently 
ranks among the industries with the highest rates of work-related injuries 
and deaths in the United States and is unique with respect to children and 
adolescents. This is the only industry in which the workplace is often also a 
home. Youth, children and adolescents, who commonly work on farms are exposed 
to agricultural production hazards.  However, exposures to agricultural 
hazards are not only experienced by working youths, non-working children who 
live on or visit farms may also be exposed to farm hazards. Research is 
needed to expand the knowledge base for the development and implementation of 
effective and appropriate intervention strategies. 

Surveillance activities by NIOSH over the past four years indicate an 
estimated 32,800 agriculture-related injuries occurred nationally to children 
or adolescents under the age of 20 who lived on, worked on, or visited a 
farm.  Forty-four percent or about 15,000 of these injuries were work-
related, and 70% of the work injuries were incurred by youth who live on the 
farm. In fact, youth who live on farms incurred about 72% of all injuries 
which happen to youth on farms.  Fatality surveillance indicates over 100 
deaths occur to youth 19 years of age and younger on farms.  About 33% of the 
farm deaths occur to youth 15-19 years of age and males account for 85% of 
all farm deaths.  Nearly 40% of the deaths among males occur between the ages 
of 15 and 19, while about 40% of the deaths among females happen before the 
age of five.  Two regions of the United States, the South and the Midwest, 
accounted for 79% of all fatal farm injuries.  Farm tractors, farm machinery, 
stored grain, power lines, manure pits, ponds, and livestock are among the 
many hazards youth are exposed to in the agricultural workplaces. Children 
and adolescents may be exposed to agricultural production hazards not only 
through work activities, but by virtue of living on a farm, accompanying 
their parents to work, or visiting farms. 
 
Goals

The goals of childhood agricultural safety and health research grants are to 
maximize the safety and health of children and adolescents exposed to 
agricultural hazards through the prioritization, development, or 
implementation of intervention efforts.  Projects are sought in one of three 
research areas which have been identified as priority areas in the documents 
Children and Agriculture: Opportunities for Safety and Health: A National 
Action Plan http://research.marshfieldclinic.org/children/action/title.htm 
or the Childhood Agricultural Injury Prevention: Progress Report and Updated 
National Action Plan from the 2001 Summit 
http://www.marshfieldclinic.org/research/children/childrensReport/ 
and provided below:

o Develop and Evaluate New or Existing Enhanced Control Technologies.  

Control technologies, in the broadest sense, include any strategy which will 
control the exposure of children to agricultural hazards. Exposures to 
agricultural hazards may be reduced through engineering controls and/or 
administrative controls. Examples of research efforts which are appropriate 
under this priority area include, but are not limited to: (a) engineering 
controls: these could encompass the development and evaluation of new, or the 
application and evaluation of existing, equipment or devices which could 
prevent childhood agricultural injuries, such as ensuring that agricultural 
structures have proper barriers and warnings, developing and evaluating play 
area designs to reduce child exposures to hazards, and developing and 
evaluating, or evaluating existing, sensor technology to notify operators or 
automatically shut down machines when children are in harms way and/or (b) 
administrative controls: these could encompass the evaluation of the impact 
of changes in work practices, such as limiting the type of work a youth does 
[e.g., not allowing youth under 16 to drive tractors or evaluation of the 
impact of the North American Guidelines for Children's Agricultural Tasks 
(NAGCATs)], modification of work periods, (such as limiting the amount of 
time a youth works), limiting the exposure of the youth (ensuring equipment 
in the work environment is properly shielded or limiting loads lifted or 
carried), and the type and amount of training and supervision given to the 
young worker.

o Develop and Evaluate Incentives which Encourage Adults to Adopt Injury 
Control Strategies to Protect Youth. 

Adults are the primary agent for determining the safety of youth on farms. 
Understanding the factors which cause adults to adopt protective activities 
for youth on their farms or cease activities which increase risk for youth 
are important to prevention efforts.  Identifying the type, kind and 
magnitude of incentives which lead adults to adopt injury control strategies 
can lead to reduced risk for youth who live on, work on, or visit farms.  
Examples of research efforts which are appropriate under this priority area 
include, but are not limited to: (a) incentives needed by adults to adopt 
methods to reduce or eliminate the risk of injury from agricultural 
production, such as implementing affordable and accessible childcare which is 
readily available to farm families, or (b) incentives required to establish 
safe play and recreation areas for youth on farms, or c) for farms that are 
using young workers, incentives which are successful in getting adults to use 
model programs for training and supervising young agricultural workers to 
reduce the risk of injury. 

o Identify the Economic and/or Social Consequences of Youth Working on Farms.

Data on positive as well as negative outcomes of youth's involvement in 
agriculture are needed to develop a balanced response to protecting children. 
Examples of research efforts which are appropriate under this priority area 
include, but are not limited to: (a) studies to estimate the societal and 
economic costs and consequences associated with childhood agricultural 
injury; (b) assessments of short- and long-term disability from injuries; (c) 
assessment of short- and long-term psychosocial outcomes (positive and/or 
negative) related to children's and adolescents' participation in different 
types of agricultural work; (d) actual costs to protect youth from hazards on 
the farm; (e) physical assessments of children and adolescents who have been 
exposed to agricultural hazards such as agricultural chemicals, organic 
dusts, toxic gases, nitrates, volatile organic compounds, oils and solvents; 
and, (f) studies of the impact of noise, vibration, cumulative trauma, and 
other work or environment-induced health hazards on children and adolescents 
working on farms.

Useful Reference

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 individual research project grant (R01) 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 August 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. It also uses the modular budget format, 
rather than the detailed budget format (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  This program does not require cost sharing.

FUNDS AVAILABLE

NIOSH intends to commit approximately one million ($ 1,000,000)in fiscal year 
(FY) 2003 to fund approximately four to six new and/or competitive 
continuation grants in response to this RFA. An applicant may request a 
project period of up to 3 years and a budget for direct costs of up to 
$250,000 per year.  Because the nature and scope of the proposed research 
will vary from application to application, it is anticipated that the size 
and duration of each award will also vary. Although the financial plans of 
NIOSH provide support for this program, awards pursuant to this RFA are 
contingent upon the availability of funds and the receipt of a sufficient 
number of meritorious applications. 

Use of Funds

Applicants should include in their budget travel funds for one trip per year 
for an annual meeting with NIOSH scientists to be held in Morgantown, West 
Virginia.  The purpose of this meeting is to provide an opportunity for the 
exchange and dissemination of scientific information.

ELIGIBLE INSTITUTIONS

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

o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, 
  and laboratories.
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic and foreign
o Faith-based or community-based organizations
o Indian Tribes, Tribal Governments, Colleges, and/or Organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research 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 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.

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.  This RFA and other CDC Announcements can be found on the CDC 
HomePage at http://www.cdc.gov/, under the Funding Section (see Grants 
and Cooperative Agreements scroll down to Occupational Safety and Health).  
This RFA can also be found on the NIOSH HomePage 
http://www.cdc.gov/niosh/homepage.html, under Extramural Programs, Current 
Funding Opportunities.

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:  ahc0@cdc.gov

Direct your questions about NIOSH agricultural research program issues 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 inquiries 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-03-003
Telephone:  (412) 386-6826
Email:  lguesws@cdc.gov

LETTER OF INTENT

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

o Descriptive title of the proposed research
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 is 
used 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 and should be sent 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 

SUBMITTING AN APPLICATION   

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.  

SUPPLEMENTAL 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. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular grant format.  The modular grant format simplifies the preparation of 
the budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the 
research grant application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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/labels.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:

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 

APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of the 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.  Incomplete applications will be returned to the 
applicant without further consideration. And, if the application is not 
responsive to the RFA, NIOSH staff may contact the applicant to determine 
whether to return the application to the applicant or submit it for review in 
competition with unsolicited applications at the next appropriate NIH review 
cycle.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by a scientific review group convened by 
NIOSH 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 
scientific or technical 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 Secondary Review Committee.

REVIEW CRITERIA

Review Criteria

The criteria that NIOSH will use to review applications for scientific 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 research will 
have a substantial impact on the pursuit of these goals:

o Significance
o Approach
o Innovation
o Investigator
o Environment

The scientific 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 scientific impact and thus 
deserve a high priority score.  For example it may propose to carry out 
important work that by its nature is not innovative but essential to move a 
field forward.

o SIGNIFICANCE: Does this study 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?  Define the 
significance of the proposed research to the prioritization, development, or 
implementation of intervention efforts. 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?  How will the 
proposed research meet the goals of the program to prioritize, develop, or 
implement intervention efforts? 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?

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 
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: 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.  

o Availability of special opportunities for furthering research programs 
through the use of unusual talent resources, populations, or environmental 
conditions in other countries which are not readily available in the United 
States or which provide augmentation of existing U.S. resources.  

Programmatic Review Criteria

o  Magnitude of the problem in terms of numbers of children affected.
o  Severity of the disease or injury in the population.
o  Likelihood of developing applied technical knowledge for the prevention of 
childhood agricultural safety and health hazards on a national or regional 
basis.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: April 18, 2003
Application Receipt Date: May 23, 2003
Earliest Anticipated Start Date: August 1, 2003

AWARD CRITERIA

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

o Scientific merit
o Availability of funds
o Programmatic priorities

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.

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html.

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/women_min.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 must 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 must 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
6100 Executive Boulevard, Suite 3B01, MSC 7501
Rockville, Maryland 20892-7507
(Note: For Express or Hand Delivered Mail, Use Zip Code 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: (if 
applicable) 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.

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.

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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