NIH Guide: NIOSH EXPLORATORY/DEVELOPMENTAL GRANT (R21) PROGRAM

NIOSH EXPLORATORY/DEVELOPMENTAL GRANT (R21) PROGRAM

Release Date: October 22, 2001

RFA NUMBER: RFA-OH-02-001

National Institute for Occupational Safety and Health, (NIOSH)

Letter of Intent: November 7, 2001
Application Receipt Date: December 27, 2001

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.
MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS
REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR
BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398
(REVISION 5/2001) AVAILABLE AT
https://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The National Institute of Occupational Safety and Health (NIOSH)
invites applications for Exploratory/Developmental Grants (R21) in
research areas that are relevant to the research goals described
in the National Occupational Research Agenda (NORA). The overall
purpose of NORA is to provide a framework for research programs
that provide the critical knowledge that can be used in preventing
occupational diseases and injuries and foster our understanding of
their underlying pathophysiology. For this RFA, research projects
must address one of the following areas: 1) Work Organization:
Cardiovascular Disease, 2)Work Organization: Depression, 3) Health
Care Workers Including Violence, 4)Chronic Obstructive Pulmonary
Disease (COPD)and Work, 5) Traumatic Injury, 6) Hearing loss,
7)Agricultural Injuries To Children, and 8) Intervention
Effectiveness Research In Occupational Health. Applications for
other areas should be submitted to the regular grants program of NIOSH.

The objective of the exploratory/developmental mechanism (R21) is
to encourage applications from institutions that are interested in
testing innovative or conceptually creative ideas that are
scientifically sound and may advance our understanding of safety
and occupational health. Another objective is to encourage
necessary initial development to provide a basis for important
future research.

These are short-term awards (up to two years) with limited funding
(maximum $75,000 per year for direct costs). Applicants are
encouraged to use this mechanism to explore the feasibility of an
innovative research question or approach, which may not qualify
through existing research grant programs, or may not be
competitive as a standard research project grant (R01).

Potential applicants should also be aware of the program
announcements for the NIOSH Small Grant (R03) Program PA-99-144.
This small grant program is for pilot studies with funding
requests for a maximum of $25,000 direct costs per year for up to
two years. This program announcement is also available on the
NIOSH Home Page; http://www.cdc.gov/niosh/norhmpg.html You may also
refer to http://www.cdc.gov/funding.htm.

HEALTHY PEOPLE 2010

CDC is committed to achieving the health promotion and disease
prevention objectives of Healthy People 2010, a national
activity to reduce morbidity and mortality and improve the quality
of life. This announcement is related to the focus area of
Occupational Safety and Health. The internet site is:
http://www.health.gov/healthypeople/

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, public and
private nonprofit and for-profit organizations and by governments
and their agencies; that is, universities, colleges, research
institutions, hospitals, other public and private nonprofit and
for-profit organizations, State and local governments or their
bona fide agents, including the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth
of the Northern Mariana Islands, American Samoa, Guam, the
Federated States of Micronesia, the Republic of the Marshall
Islands, and the Republic of Palau, federally recognized Indian
tribal governments, Indian tribes, or Indian tribal organizations,
and small, minority, and women-owned businesses that meet the
above criteria. Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as Principal
Investigators.

Note: Title 2 of the 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.

MECHANISM OF SUPPORT

This mechanism of support will be the individual research project
grant (R21). Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant. The total requested project period for an application
submitted in response to this RFA may not exceed two (2) years.
This RFA is a one-time solicitation.

FUNDS AVAILABLE

Approximately $3,200,000 is available in FY 2002 to fund 32 awards
under this RFA. The maximum amount that may be requested for an
award is $75,000 direct cost. Facilities and Administrative (F&A)
costs will be awarded based on the negotiated rate at the time of
the award. It is expected that the awards will begin on or about
June 1, 2002 and will be made for a 12-month budget period within
a project period of up to 2 years. Funding estimates may change.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress as evidenced by required
reports and the availability of funds.

Use of Funds

Applicants should include in their budgets funds for one trip per
year for an annual meeting of grantees to be held in Washington,
D.C. The purpose of this meeting is to provide an opportunity for
the exchange and dissemination of scientific information.

RESEARCH OBJECTIVES

In 1996, NIOSH and its partners in the public and private sectors
developed the National Occupational Research Agenda (NORA) to
provide a framework to guide occupational safety and health
research into the next decade not only for NIOSH, but also for the
entire occupational safety and health community. Approximately
500 organizations and individuals outside NIOSH provided input
into the development of NORA. This attempt to guide and
coordinate research nationally is responsive to a broadly
perceived need to address systematically those topics that are
most pressing and most likely to yield gains to the worker and the
nation.

Potential applicants may obtain a copy of the "National
Occupational Research Agenda" (HHS, CDC, NIOSH Publication
No.96-115) from the National Institute for Occupational Safety and
Health, telephone (800) 356-4674. It is also available on the
internet at http://www.cdc.gov/niosh/nora.html

While applications may involve a wide variety of biomedical,
behavioral, clinical, socio-culture, or other disciplines,
relevance to the mission of NIOSH must be clear. The Institute's
mission statement, extramural research program descriptions, list
of special emphasis areas, and active program announcements may be
found at NIOSH's Internet web site: http://www.cdc.gov/niosh/homepage.html.

This NIOSH Exploratory/Developmental Grant (R21) Program provides
limited financial support for exploring the feasibility of
innovative or creative research questions within the research
interests of NORA. The overall purpose of this RFA is to
stimulate investigations in eight priority areas (see below) that
either have received few applications, have limited grant support
from NIOSH, or have been identified as priority research needs.

The Research Areas for this RFA are:

o Work Organization: Cardiovascular Disease

In the U.S., cardiovascular disease (CVD) is a health problem of
staggering proportions. An estimated 58 million Americans have
CVD, of whom 50 million have hypertension. Over 7 million
Americans suffer from coronary heart disease which is responsible
for more deaths each year in the U.S. than all forms of cancer
combined. That occupational factors play a role in the etiology
of CVD is undisputed. However, the nature and role of work
organization as an etiologic factor is unclear.

Types of research applications that are appropriate for this topic
include but are not limited to the following areas: (1) role of
work organization on CVD, and (2) work organization on worker
groups such as miners, women etc.

References

Harlan WR, Sharret AR, Weill H, Turino GM, Berhani NO, Resnekow L.
Impact of the environment on cardiovascular disease, report of the
American Heart Association Task Force on environment and the
cardiovascular system. Circulation 1981;63:243A-6A.

Roseman KD. Cardiovascular disease and environmental exposure. Br
J Ind Med 1979;36:85-97.

o Work Organization: Depression

Depression has been judged as one of if not the most disabling
health condition worldwide, judged by sheer prevalence. Worker
illness results in nearly 175 million lost workdays and
productivity losses of $24 billion annually in the U.S. alone.
However, unlike CVD and other health condition, there is limited
information on the occupational aspects of depression. In the
present environment, the rapid organizational changes expose
workers to a broad range of stressors with suspected links to
depression.

Types of research applications that are appropriate for this topic
include but are not limited to the following areas: (1) role of
work organization on depression, and (2) work organization on
worker groups such as miners, women etc.

References

Sauter, SL, Hurrell, JJ Jr, Roberts-Fox, H, Tetrick, LE, and
Barling, J. 1999. Occupational health psychology: An emerging
discipline. Industrial Health,37:199-211.

Grosch, J and Murphy, LR. 1998. Occupational differences in
depression and global health: Results from a national sample of US
workers. Journal of Occupational and Environmental Medicine,
40:153-164.

Revoke DA and May, HJ Occupational stress, social support, and
depression. Health Psychology, 4 (1), 61-77. 1985 via George Wise,
Missouri Extension Child and Family Development Specialist, July
1985

o Health Care Workers, Including Violence

Currently, there are approximately 10 million health care workers
in the U.S. performing in numerous professional and support
positions in various work environments (hospitals, laboratories,
home health care, and emergency services). This number is
projected to increase to 13 million by 2006. Health care workers
are at risk to injury or illness from occupational exposures for
example; hazardous chemicals (solvents and chemotheraputic
agents), infectious agents (viruses and bacteria), physical
(violence and noise), biomechanical (lifting and standing), and
psychological (stress and work shift). Approaches to reduce and
prevent injury and illness seen in other industries and consistent
with the concept of healthy work organizations have not been
realized in the heath care system, particularly in the area of
work-related violence.

Types of research applications that are appropriate for this topic
include but are not limited to: 1) identification of risk factors
associated with injury or illness of health care workers,
2)innovative prevention strategies to reduce injury and illness
among health care workers, and 3) role of work organizations on
health care worker violence.

References

U.S. Department of Labor (OSHA): Guidelines for Preventing
Workplace Violence for Health Care and Social Service Workers.
Publication no. 3148, 1998.

o Chronic Obstructive Pulmonary Disease (COPD) and Work

COPD is one of the leading respiratory diseases in the U.S. and a
major cause of morbidity and mortality. Many occupational
exposures (both by themselves or in combination with smoking) are
known to cause COPD. In addition, workplace exposures contribute
to the development, persistence, and exacerbation of COPD brought
about through non-occupational causes. The proportion of COPD
attributable to occupational exposure in the general population is
estimated to be 14 percent, providing a point estimate of 14,257
COPD deaths annually in the United States attributable to
occupational dust exposure.

The causal relationship between occupational exposures such as
coal mine dust and COPD development has been well researched and
now generally accepted. However, the evidence is either limited,
suggestive, or non-existent, for other types of occupational
exposures such as >nuisance dusts=, now called >particulate=.
Further investigation is required to improve the understanding of
the contribution of work exposures to the overall population
burden of COPD, as well as to better understand the types,
severity, and distribution of the occupational exposures that
contribute to or result in lung dysfunction.

Types of research applications that are appropriate for this topic
include but are not limited to the following areas: 1) the
assessment of the true extent of COPD associated with workplace
exposures, including the contribution from exacerbation of non-
occupationally caused COPD by workplace exposures; 2) the
identification of exposures which cause COPD, including assessment
of the group of dusts termed >particles not otherwise regulated or
classified= (PNOR/PNOC) and study of the effects of mixed dust
exposures; 3) the relationship between various work environments,
symptom development, accelerated lung function loss, and the
subsequent development of COPD; 4) documentation of the beneficial
effects of substantially reducing or eliminating exposure to
occupational respiratory hazards on the reduction or prevention of
COPD; 5) evaluation of workplace medical screening/surveillance
programs or data, obtained from on-going and completed population-
based studies, to improve the understanding of the occupational
contribution to COPD; and 6) animal models of occupational COPD.

References

American Lung Association. 1996. Trends in chronic bronchitis and
emphysema: morbidity and mortality. New York, NY. pp.1-5.
Frank E. Speizer. Occupational and environmental lung diseases: an
overview. Environmental Health Perspectives Volume 108, Supplement
4, August 2000.

Becklake MR.1994. The work relatedness of airways dysfunction. In:
Proceedings of the 9th international symposium in epidemiology in
occupational health. DHHS(NIOSH) Publication No.94-112:1-28.

o Traumatic Injury

The risk of occupational traumatic injuries affects all 130
million U.S. workers to some degree. In 1998, 2.6 million of the
5.5 million nonfatal occupational injuries in U.S. private sector
industries resulted in lost work days, restricted duty, or both.
Traumatic occupational injuries killed 6,026 Americans in 1998.
The economic burden from traumatic occupational injuries has been
estimated at approximately $145 billion (in 1992), in the same
range as the costs ($160-170 billion) for cancer and circulatory
diseases. Lack of a well coordinated or integrated approach has
resulted in the inability of some previous research activities to
reach a point of impacting the workplace, while others have been
applied in only limited situations with no plans or mechanism for
broad-based dissemination.

The proposed projects should take advantage of existing knowledge
regarding high-risk work activities and known and potential
interventions. Intervention projects which assess the practical
effectiveness of occupational injury prevention interventions
(e.g., strategies, technologies, and programs) in reducing risks,
exposures, injuries and their negative economic and social effects
are of particular interest. Research should consider feasibility
and cost effectiveness, as well as disincentives and other
potential barriers to implementation.

Topics for this project area include, but are not limited to: 1)
systematic evaluation of the effectiveness of intervention
methodologies; 2) practical and usefulness of specific control
strategies, technologies, or personal protective equipment; 3)
components of effective programs that reduce traumatic injuries,
including worker participation, training, engineering solutions,
and organization or administrative aspects; and 4) identification
of critical factors( risk factors, prevention strategies,
evaluation techniques, dissemination and technology transfer
approaches) for implementing and conducting effective programs
that reduce or prevent traumatic injuries. Dissemination and
technology transfer mechanisms could be developed to inform at-
risk populationsBemployers, safety and health practitioners, and
workers of effective interventions, that would persuade them to
implement new methods, policies, and partnerships to effect
positive injury prevention changes in workplaces and companies.

o Hearing Loss

Work-related hearing loss from exposure to noise has long been
recognized. However, job-related hearing loss from exposure to
chemicals in combination with noise has been recognized only
recently. Research from the 1990s showed that some workers
exposed only to chemicals have more risk of occupational hearing
loss than workers exposed to noise alone In addition, studies
have found that workers exposed to both noise and chemicals were
at much greater risk of hearing loss than workers exposed to
either noise or chemicals alone. There is a need for studies that
will support development of dose-response relationships so that
exposure limits can be established to protect workers= hearing
from combined noise and chemical exposures.

Noise exposure parameters of interest include, but are not limited
to steady state, fluctuating, intermittent and impulse/impact.
The chemicals of interest include solvents, metals, insecticides,
herbicides, pesticides, and asphyxiates. Populations of interest
include, youths, miners, construction and agricultural workers.

Types of research applications that are appropriate for this topic
include but are not limited to the following areas:

(1) systematic evaluation of the effectiveness of interventions
(2) biological effects and biological responses induced by noise
or other ototoxic agents including secondary risk factors such as
hypertension, head trauma, diabetes, blood lipids, and clinical
therapeutic drugs; (3) individual susceptibility to hearing loss
induced by noise and/or chemicals and the role of free-radicals
and antioxidants in the auditory system=s response to noise and
ototoxic chemicals; (4) evaluation of the dose-response
relationships between hearing loss and exposure to noise,
chemicals, or noise and chemicals; and (5) laboratory studies that
mimic work place noise/chemical exposures are appropriate as long
as the results are directly applicable to the work place.

o Agricultural Injuries To Children

Agricultural production consistently ranks among industries with
the highest rates of work-related injuries and deaths in the
United States, and is unique with respect to children and
adolescents. Projects are sought but not limited to research
topics that develop new or enhance existing control technologies
developed to reduce injury to youth exposed to agricultural
production hazards. Other research topics related to the area of
agricultural injuries to children are also allowed. Applications
should identify the types and geographical distribution of
agricultural production which will be addressed, and the size and
characteristics of child and adolescent populations which can
potentially be impacted by the research findings. Research topics
of interest include but are not limited to:

Develop New or Enhance Existing Control Technologies

Control technologies, include any strategy which will control the
exposure of children to agricultural hazards. Examples of
research efforts which are appropriate under this priority area
include, but are not limited to: a) engineering controlsBthese
could include the development of new or the application and
evaluation of existing equipment or devices which could prevent
childhood agricultural injuries (for example, 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 sensor
technology to notify operators or automatically shut down machines
when children are in harms way) and/or b) administrative controlsB
these could include evaluating the impact of changes in work
practices, such as limiting the type of work a youth does (i.e.,
not allowing youth under 16 to drive tractors), 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), and the type and amount of
training and supervision given to the young worker.

References

Myers JR, Hendricks K. 2001. Injuries Among Youth on Farms in the
United States, 1998. NIOSH Publication No. 2001-154.

Castillo DN, Adekoya N, Myers JR. 1999. Fatal Work-Related
Injuries in the Agricultural Production and Services Sectors Among
Youth in the United States, 1992-1996. Journal of Agromedicine
6:27-41.

o Intervention Effectiveness Research In Occupational Health

The purpose of this initiative is to stimulate research that
evaluates the effectiveness of intervention techniques which have
been implemented or proposed for reducing or preventing workplace
injuries and illnesses. While many workplace interventions have
been developed and implemented, there has been little research on
the effectiveness of these activities. Before work place
intervention strategies can be applied universally, there is a
critical need for information on how effective are the currently
used or planned strategies and approaches. The results of these
investigations will contribute significantly to improving worker
health and safety by identifying intervention strategies that are
effective. Because the issue of intervention effectiveness is of
importance to many membership groups (unions, professional
associations, etc), industries, and state health departments,
collaborative research projects between these organizations and
academic researchers are particularly encouraged.

Research applications are sought that focus on the systematic
evaluation of the effectiveness of interventions that address but
are not limited to any of the following disease or injury areas:
1) Traumatic Injuries including Violence 2)Allergic and Irritant
Dermatitis, 3)Asthma and Chronic Obstructive Pulmonary Disease,
4)Fertility and Pregnancy Abnormalities, 5)Hearing Loss,
6)Infectious Diseases, and 7)Low Back Disorders.

Fully-developed interventions either implemented or ready for
implementation are of interest, as well as applications for
comparative analysis of the effectiveness of alternate options
(e.g., cost effectiveness). The interventions to be evaluated
could be defined at any level of complexity, and range from a
regulatory or voluntary occupational safety or health standard to
the change of a single, specific work process, control technology,
training program, or informational campaign. Evaluations may
address but are not limited to (1) the practicality and usability
of specific control strategies, technologies and/or personal
protective equipment in the elimination or reduction of hazards;
(2) the identification of critical factors for implementing and
conducting effective occupational safety and health programs; (3)
the components of effective occupational safety and health
programs, including worker participation programs, training or
other organizational and administrative aspects, as well as
engineering solutions; and (4) identification and elimination of
barriers to the implementation of interventions, such as a lack of
acceptance due to practicality, perception that cost is
prohibitive, etc.

Examples of potential health, economic, and social outcome
measures may include but are not limited to, health and safety
outcomes (e.g., reductions in injury, disability, stress, or
hazard exposure); economic outcomes (e.g, the effect of the
intervention on productivity, employee turnover, income, medical,
and or societal costs); and/or social outcomes (e.g., social roles
and relationships at work and in the family and other aspects of
the work-family interface).

References

National Institute for Occupational Safety and Health. National
Occupational Research Agenda. Cincinnati, OH: U.S. Department of
Health and Human Services, Public Health Service, Centers for
Disease Control and Prevention, National Institute for
Occupational Safety and Health, DHHS (NIOSH) Publication No.96-115
(http://www.cdc.gov/niosh/nora.html.

National Institute for Occupational Safety and Health. A Model
for Research on Training Effectiveness. Cincinnati, OH: U.S.
Department of Health and Human Services, Public Health Service,
Centers for Disease Control and Prevention, National Institute for
Occupational Safety and Health, DHHS (NIOSH) Publication No.96-142
(http://www.cdc.gov/niosh/99-142.html).

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the CDC to ensure that individuals of both
sexes and the various racial and ethnic groups will be included in
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_update.htm.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts,
March 6, 1998, and is available at the following URL address:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the
program staff listed under INQUIRIES. Program staff may also
provide additional relevant information concerning the policy.

HUMAN SUBJECTS REQUIREMENTS

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

NIH policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. This policy announcement is
found in the NIH Guide for Grants and Contracts Announcement dated
June 5, 2000, at the following website:
https://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 https://grants.nih.gov/grants/olaw/olaw.htm.

URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES

All applications must be self-contained within specified page
limitations. Unless otherwise specified, 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.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

By regulation (45 CFR 74.36), grantees that are institutions of
higher education, hospitals, or non-profit organizations are
required to provide public access to research data through the
Freedom of Information Act (FOIA) under some circumstances (OMB
Circular A-110). 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. For further
information on this policy refer to page 52 in the PHS 398 grant
application or access the NIH Guide for Grants and Contracts
Announcement at:
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA 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.

LETTER OF INTENT

Prospective applicants are asked to submit, by November 7, 2001, a
letter of intent that includes the number and title of the RFA, a
descriptive title of the proposed research, the name, address, and
telephone number of the Principal Investigator, and the identities
of other key personnel and participating institutions. Although a
letter of intent is not required, is not binding, and is not used
in 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 submitted to:

Pervis C. Major, Ph.D.
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 PROCEDURES

The PHS 398 research grant application instructions and forms
(rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.pdf
must be used in applying for these grants. This version of PHS 398 is
available in an interactive, searchable format. Although
applicants are strongly encouraged to begin using the 5/2001
revision of the PHS 398 as soon as possible, the NIOSH will
continue to accept applications prepared using the 4/1998 revision
until January 9, 2002. Beginning January 10, 2002, however, the
NIOSH will return applications that are not submitted on the
5/2001 version. For further assistance contact GrantsInfo,
Telephone 301/710-0267, Email: GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

The modular grant concept establishes specific modules in which
direct costs may be requested as well as a maximum level for
requested budgets. Only limited budgetary information is required
under this approach. The just-in-time concept allows applicants
to submit certain information only when there is a possibility for
an award. It is anticipated that these changes will reduce the
administrative burden for the applicants, reviewers and NIH staff.
The research grant application form PHS 398 (rev. 5/2001) at
https://grants.nih.gov/grants/funding/phs398/phs398.html is to be
used in applying for these grants, with modular budget
instructions provided in Section C of the application
instructions. Applicants are permitted, however, to use the
4/1998 revision of the PHS 398 for scheduled application receipt
dates until January 9, 2002. If you are preparing an application
using the 4/1998 version, please refer to the step-by-step
instructions for Modular Grants available at
https://grants.nih.gov/grants/funding/modular/modular.htm.
Additional information about Modular Grants is also available on
this site.

The RFA label available in the PHS 398 (rev. 5/2001) application
form (https://grants.nih.gov/grants/funding/phs398/labels.pdf) 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.

Submit a signed original of the application and three exact
photocopies, including the checklist, in one package to:

CENTER FOR SCIENTIFIC REVIEW
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:

Applications must be received by December 27, 2001. If an
application is received after that date, it will be returned to
the applicant without 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. CSR and NIOSH will not accept
any application that is essentially the same as one already
reviewed. This does not preclude the submission of a substantial
revision of an application already reviewed, but such an
application must follow the guidance in the PHS Form 398
application instructions for the preparation of revised
applications, including an Introduction addressing the previous
critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by
CSR and responsiveness by NIOSH. Applications determined to be
incomplete or unresponsive to this RFA will be returned to the
applicant without further consideration. Applications that are
complete and responsive to the RFA will be reviewed for technical
merit by a scientific review group convened by NIOSH.

All applications will be judged on the basis of the scientific
merit of the proposed project and the documented ability of the
investigators to meet the research objectives of the RFA. As part
of the scientific merit review, all applications will receive a
written critique and undergo a process in which only those
applications deemed to have the highest scientific merit,
generally the top half of applications under review, will be
discussed and assigned a priority score.

The criteria that NIOSH will use to review applications for
scientific merit and for meeting program objectives are provided
below.

Scientific Review Criteria

o Significance - Does this study address an important problem
related to the topical research issues outlined in this
announcement? If the aims of the application are achieved, how
will scientific knowledge be advanced? What will be the effect of
these studies on the concepts or methods that drive this field?

o Approach - Are the conceptual framework, design (including
composition of study population), methods, and analyses adequately
developed, well-integrated and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas
and consider alternative tactics?

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 done contribute to the probability of success? Do the
proposed experiments take advantage of unique features of the
scientific environment or employ useful collaborative
arrangements? Is there documentation of cooperation from
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?

o Adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of
the research. Plans for the recruitment and retention of subjects
will also be evaluated.

o The adequacy of the proposed protection of humans, animals, or
the environment, to the extent that they may be adversely affected
by the project proposed in the application.

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 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.

SCHEDULE

Letter of Intent Receipt Date: November 7, 2001
Application Receipt Date: December 27, 2001
Anticipated Award Date: June 1, 2002

AWARD CRITERIA

Applications will be considered for award based upon (a)
scientific merit, (b) program importance, (c) program balance of
research areas, and (d) availability of funds.

INQUIRIES

Inquiries concerning this RFA are encouraged. The opportunity to
clarify any issues or questions from potential applicants is
welcome. This RFA and other CDC/NIOSH Announcements can be found
on the CDC HomePage (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) under "Extramural Programs, Current
Funding Opportunities.

Direct inquiries regarding programmatic issues to:

Adele M. Childress, Ph.D. M.S.P.H.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-30
Atlanta, GA 30333
Telephone: 404/639-1493
FAX: 404/639-0035
Email: ahc0@cdc.gov

Direct inquiries regarding grants business management matters to:

Joanne Wojcik
Grants Management Branch
Procurement and Grants Office
CDC Announcement Number CDC 02014
Centers for Disease Control and Prevention
2920 Brandywine Road, Suite 3000
Atlanta, GA 30341-4146
Telephone: 770/488-2717
FAX: 770/488-2777
Email: jcw6@cdc.gov

AUTHORITY AND REGULATIONS

The Catalog of Federal Domestic Assistance number is: 93.262 for
the National Institute for Occupational Safety and Health (NIOSH).
This program is authorized under the Public Health Service Act,
as amended, Section 301(a) [42 U.S.C. 241(a)], and the
Occupational Safety and Health Act of 1970, Section 20(a) [29
U.S.C. 669(a)]. The applicable program regulation is 42 CFR Part 52.

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, 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.

SMOKE-FREE WORKPLACE

CDC strongly encourages all grant recipients to provide a
smoke-free workplace and promote the non-use of all tobacco
products, and Public Law 103-227, the Pro-Children Act of 1994,
prohibits smoking in certain facilities that receive Federal funds
in which education, library, day care, health care, and early
childhood development services are provided to children.

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."

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	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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