NIH Guide: COMMUNITY PARTNERS FOR HEALTHY FARMING INTERVENTION

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
https://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
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone 301/710-0267,
Email: GrantsInfo@nih.gov.

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:
https://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:

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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a
complete copy of the updated Guidelines are available at
https://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
https://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 https://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
https://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.

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