COMMUNITY PARTNERS FOR HEALTHY FARMING INTERVENTION

RELEASE DATE:  April 9, 2003

RFA: OH-03-004

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

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

LETTER OF INTENT RECEIPT DATE: May 27, 2003

APPLICATION RECEIPT DATE: June 13, 2003

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 Special Requirements
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 a cooperative agreement program for Community 
Partners for Healthy Farming Intervention.  This program addresses the 
"Healthy People 2010" focus areas of Educational and Community-Based Programs 
and Occupational Safety and Health.  The purpose of this cooperative agreement 
is to develop community-based farm safety and health interventions research 
and prevention projects through partnerships with researchers, workers, farm 
managers, local agricultural communities, and other stakeholders. 

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 priority areas.  The NORA priority areas with 
specific relevance to this announcement are: traumatic injuries and 
intervention effectiveness research.  Information about NORA is available 
through the NIOSH Home Page; http://www.cdc.gov/niosh/nora/

RESEARCH OBJECTIVES

Background

Agriculture consistently ranks as one of the most hazardous industries in the 
United States.  Acute traumatic injury and accidental death are among the most 
significant and striking occupational hazards in agriculture.  There were 
approximately 26 deaths per 100,000 workers in the agricultural sector 
[agriculture, forestry, and fishing] during 1999.  The average annual fatality 
rate for the United States civilian working population for this same time 
period was approximately five deaths per 100,000 workers. Of special concern 
are the children (over 100) killed each year while involved in farm 
activities. Each day approximately 500 agricultural workers suffer lost-work-
time injuries, and about five percent of these result in permanent impairment. 
Those who work in agriculture are also at increased risk for occupational 
morbidity from musculoskeletal disorders, certain cancers, reproductive 
disorders, dermatological conditions, zoonotic diseases, hearing loss, stress 
related mental disorders, and occupational lung diseases.  Farm tractors, farm 
machinery, stored grain silos, power lines, manure pits, and livestock are 
among the many hazards workers are exposed to in agricultural workplaces. 

Hired workers, farm owner-operators, and unpaid family members who live in the 
work environment are at risk from the health and safety hazards of farming in 
the United States.  The number of hired workers varies widely by season from 
600,000 to 950,000 workers [United States Department of Agriculture (USDA), 
National Agricultural Statistics Service, Farm Labor, 1995 & 1996].  USDA data 
show 5.9 million persons own, operate, and manage farms or are family members 
who live on these farms (Farm Costs and Return Survey, 1993).  It is unknown 
how many children and other family members of migrant or seasonal workers who 
are not recorded as working are at risk.  These agricultural workers and their 
families experience a disproportionate share of fatalities, injuries, and 
diseases associated with many physical, chemical, and biological hazards.  
Many agriculture workers are not covered by the same protections as workers in 
other occupations (e.g., workers' compensation, Occupational Safety and Health 
Administration regulations), and data on such injuries may not be available or 
may underestimate the scope of the problem.  Furthermore, unlike other 
industries, farm children begin working at a young age, are at risk to many 
occupational hazards while working or living at the worksite, and experience 
injuries and fatalities at a younger age than in other industries. 

In December, 1994, an external review panel was convened to conduct an 
evaluation of the NIOSH Agriculture Initiative.  The panel recommended that 
NIOSH continue its support of the Agriculture Initiative and promote the 
development of community-based research and prevention projects which will 
link the traditionally supported research and surveillance projects directly 
to the agricultural community.  The panel encouraged enhanced collaboration 
between those engaged in research and those engaged in intervention/prevention 
activities at the community level. 

This program is responsive to these recommendations through the development of 
a cooperative agreement to conduct community-based pilot intervention or 
demonstration research projects at the community level. In these efforts, 
CDC/NIOSH encourages the formation of partnerships with public health, 
research organizations, and community-based groups serving agricultural 
populations.

Goals

The goal of this intervention/prevention research program is to prevent 
occupationally related disease and injury in the agriculture industry through 
community-based intervention or demonstration projects aimed at piloting and 
evaluating regulatory, behavioral, education, control or other interventions. 
It is intended that these goals will be accomplished through the development 
of partnerships with researchers and agricultural community groups or 
populations in order that interventions/preventions are piloted and evaluated 
within the agricultural working population.  The focus for agricultural 
workplace safety and health intervention efforts can include specific 
engineering control technologies, information dissemination and health 
communication practices, worker/management participatory safety and health 
programs, and family and community safety and health training.  Although many 
intervention strategies have been applied to various work settings, knowledge 
about the most effective is limited.  Employers, owner-operators, agricultural 
workers, public decision makers, cooperative extension services agents, and 
others need this information to make informed decisions about which prevention 
strategies work well and support the use of limited resources. 

Research is needed to pilot and evaluate intervention/prevention efforts 
which, if successful, will be applicable at the regional or national level. 
This work should be conducted in cooperation with agricultural workers and 
employers to insure consideration of specific economic and organizational 
factors that determine if interventions will be adopted by a particular 
population.  Cultural, educational, gender, geographical, and other related 
characteristics of at risk populations will influence how safety and health 
messages are designed, distributed, and received.  Farm workers (including 
migrant, seasonal, minority, and permanent employees as well as women and 
children of the agricultural community) and agricultural organizations should 
join efforts to identify appropriate techniques for information dissemination 
and develop outcome measurements which can be utilized to determine the 
effectiveness of various dissemination efforts.

Useful References

Healthy People 2010 (Full Report: Stock No. 017-001-00547-9).  Superintendent 
of Documents, Government Printing Office, Washington D.C. 20402-9325. 
Telephone (202) 512-1800 or visit the internet site: 
http://www.healthypeople.gov/ 

MECHANISM OF SUPPORT

This RFA will use NIOSH (U01) 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/archive/grants/policy/nihgps/part_i.htm#matchorcost.

The NIOSH (U01)is a research project 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/CDC intends to commit approximately $850,000 in FY 2003 to fund five to 
seven awards to support a community partners for healthy farming intervention 
program.  An applicant may request a project period of up to four years and a 
budget for direct costs of up to $180,000 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. At this time, it 
is not known if this RFA will be reissued.  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 other principal investigators and NIOSH/CDC 
scientists 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 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 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

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 in 45 CFR Parts 74 and 92, 
and PHS Grants Policy Statement.  The administrative and funding instrument 
used for this program is a research project cooperative agreement (U01), an 
assistance mechanism (rather than an acquisition mechanism) in which 
substantial NIOSH scientific and/or programmatic involvement with the awardee 
is anticipated during performance of the activity.

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

1. Recipient Responsibilities

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

Recipient will:

a.  provide study participants with individual notification letters when 
medical tests are performed, 

b.  develop and submit semiannual progress reports in a standard format that 
is agreed upon after an award is made, 

c.  provide program management oversight for the project, and 

d.  notify study participants of the overall study results. 

2.  NIOSH Staff Responsibilities

NIOSH will have substantial scientific programmatic involvement during conduct 
of this activity, through technical assistance, advice, and coordination.  
NIOSH staff will:

a.  Serve as a scientific liaison between the awardee and other program staff 
at NIOSH with experience in the occupational health issues of MSDs and 
epidemiology;

b.  provide expert consultation in the area of occupational epidemiology;

c.  provide technical advice on monitoring of field data collection, 
developing operating guidelines, quality control procedures, and developing 
policies/protocols for dealing with recurrent situations; 

d.  facilitate collaborative efforts to compile and disseminate program 
results through presentations and publications,

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

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.  

o 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

o 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

o Direct your questions about the peer review issues to:
 
Gwen Cattledge, Ph.D.
Scientific Review 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 1423, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2508
Fax: (404) 498-2571
Email: gcattledge@cdc.gov
 
o 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-03-004
Telephone: (412) 386-6826
Email: lguess@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 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 and should be sent to: 

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

SUBMITTING AN APPLICATION   

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:

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. 

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/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:

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

APPLICATION PROCESSING: Applications must be received on or before 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 and/or non-responsive 
applications will be returned to the applicant without further consideration. 

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

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

REVIEW CRITERIA

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

(1)  SIGNIFICANCE: Does this study address an important problem related to 
intervention/prevention research issues outlined in this announcement?  If the 
aims of the application are achieved, how will scientific knowledge be 
advanced?  What will be the effect of these studies on the concepts or methods 
that drive this field? Describe the significance of the proposed 
intervention(s) and the number of people likely to benefit.

(2)  APPROACH: Are the conceptual framework, design (including composition of 
study population), methods, and analyses adequately developed, well-
integrated, and appropriate to the purpose of reducing injuries, illness, 
and/or hazard exposure to agricultural workers? Describe the feasibility of 
the intervention and the value of adoption and sustainability of the 
intervention (e.g. the impact of trends in agriculture, support by partners 
and stakeholders, costs of implementation, effects on production, and 
community norms). Do you acknowledge potential problem areas and consider 
alternative tactics? Does the proposal include involvement of agricultural 
workers, communities, and other stakeholders in the planning, implementation, 
and evaluation of the intervention?  Is the proposed evaluation system 
detailed and capable of measuring program progress, effectiveness, impact, and 
outcome?

(3)  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?

(4)  INVESTIGATOR: Are you appropriately trained and well-suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers, if any?

(5)  ENVIRONMENT: Does the scientific environment in which your work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there support and commitment by 
partners/stakeholders (e.g. agricultural workers, agricultural organizations, 
agribusiness) in the development of this project. Is there documentation of 
cooperation from industry, unions, communities, or other participants 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.  

PROGRAMMATIC REVIEW CRITERIA:

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  May 27, 2003
Application Receipt Date:  June 13, 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.

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. 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.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS: It is 
the policy of the NIOSH/CDC to ensure that individuals of both sexes and the 
various racial and ethnic groups will be included in NIOSH/CDC-supported 
research projects involving human subjects, whenever feasible and appropriate. 
Racial and ethnic groups are those defined in OMB Directive No. 15 and include 
American Indian or Alaska Native, Asian, Black or African American, Hispanic 
or Latino, Native Hawaiian or other Pacific Islander.  Applicants shall ensure 
that women, racial and ethnic minority populations are appropriately 
represented in applications for research involving human subjects.  Where 
clear and compelling rationale exist that inclusion is inappropriate or not 
feasible, this situation must be explained as part of the application.  This 
policy does not apply to research studies when the investigator cannot control 
the race, ethnicity, and/or sex of subjects.  Further guidance to this policy 
is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and 
dated Friday, September 15, 1995.

All investigators proposing research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," published in the NIH Guide for Grants and Contracts on August 2, 
2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm 

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/CDC 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

ANIMAL SUBJECTS REQUIREMENTS: If the proposed project involves research on 
animal subjects, compliance with the APHS Policy on Humane Care and Use of 
Laboratory Animals by Awardee Institution 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
 
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/CDC GRANT APPLICATIONS OR APPENDICES: All applications for 
NIOSH/CDC funding must be self-contained within specified page limitations. 
Unless otherwise specified in a NIOSH/CDC solicitation, internet addresses 
(URLs) should not be used to provide information necessary to the review 
because reviewers are under no obligation to view the Internet sites.  
Reviewers are cautioned that their anonymity may be compromised when they 
directly access an Internet site.

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 Center 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, NIOSH/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 NIOSH/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 NIOSH/CDC grants and cooperative agreements need to be careful 
to prevent NIOSH/CDC funds from being used to influence or promote pending 
legislation.  With respect to conferences, public events, publication, and 
"grass roots" activities that relate to specific legislation, recipients of 
NIOSH/CDC funds should give attention to isolating and separating the 
appropriate use of NIOSH/CDC funds from non-NIOSH/CDC funds.  NIOSH/CDC also 
cautions recipients of NISOH?CDC funds to be careful not to give the 
appearance that NIOSH/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-let 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.


Return to Volume Index

Return to NIH Guide Main Index


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.