IMPLEMENTATION OF THE NATIONAL OCCUPATIONAL RESEARCH AGENDA

Release Date:  March 4, 1999 

RFA:  OH-99-002

P.T.

National Institute for Occupational Safety and Health

National Cancer Institute
National Heart, Lung, and Blood Institute
National Institute on Aging
National Institute on Deafness and Other Communication Disorders
National Institute of Environmental Health Sciences

Letter of Intent Receipt Date:  April 19, 1999
Application Receipt Date:  June 10, 1999

THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE

The Centers for Disease Control and Prevention (CDC) and the National
Institutes of Health (NIH), announce the availability of fiscal year (FY) 1999
funds for grant applications for research related to some of the priority
areas identified in the National Occupational Research Agenda (NORA) that is
described in the RESEARCH OBJECTIVES section.  Two types of grants will be
supported:  traditional research projects and demonstration projects.

The overall purpose of this grants program is to develop knowledge that can be
used in preventing occupational diseases and injuries and to better understand
their underlying pathophysiology.  Thus, the following types of applied
research projects will be supported: causal research to identify and
investigate the relationships between hazardous working conditions and
associated occupational disease and injury; the nature and magnitude of
special risk factors experienced by older and/or minority workers; methods
research to develop more sensitive means of evaluating hazards at work sites;
and evaluations of the effectiveness of prevention and intervention programs,
including new approaches or combinations of techniques such as control
technologies, personal protective equipment and changes in work organization
factors, which have been developed and implemented in workplaces.

This Request for Applications (RFA) is jointly sponsored by several
Institutes, with varying interest in the topics given in the listed under
RESEARCH OBJECTIVES.  The National Institute for Occupational Safety and
Health (NIOSH) in CDC is interested in all eight topics.  The National Cancer
Institute (NCI) in NIH is interested in exposure assessment (4) and
surveillance research methodology (5).  The National Heart, Lung, and Blood
Institute (NHLBI) in NIH is interested in asthma and chronic obstructive
pulmonary disease (7) and organization of work - sleep disorders (8).  The
National Institute on Aging (NIA) in NIH is interested in special populations
at risk - aging workforce (6).  The National Institute on Deafness and Other
Communication Disorders (NIDCD) in NIH is interested in hearing loss (3).  The
National Institute of Environmental Health Sciences (NIEHS) in NIH is
interested in exposure assessment (4).

HEALTHY PEOPLE 2000

CDC and NIH are committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2000," a national activity to reduce
morbidity and mortality and improve the quality of life.  This RFA is related
to the priority areas of occupational safety and health and unintentional
injuries.  Potential applicants may obtain a copy of  "Healthy People 2000"
(Full Report, Stock No. 017-001-00474-0 or Summary Report, Stock No. 017-001-
00473-1) through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325, telephone (202) 512-1800.

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, and federally recognized Indian tribal
governments, Indian tribes, or Indian tribal organizations

Note:  Public Law 104-65 states that an organization described in section
501(c)(4) of the Internal Revenue Code of 1986 which engages in lobbying
activities is not eligible to receive Federal funds constituting an award,
grant (cooperative agreement), contract, loan, or any other form. 

MECHANISM OF SUPPORT

The mechanisms of support will be the individual research project grant (R01)
and demonstration project grant (R18).  The total requested project period for
an application submitted in response to this RFA may not exceed three years. 
However, specific application instructions have been modified to reflect
"MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the
NIH.  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
Institute staff. Complete and detailed instructions and information on Modular
Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm.

Applications will request direct costs in $25,000 modules, up to a total
direct cost request of $250,000 per year.  A typical modular grant application
will request the same number of modules in each year.

Application budgets will be simplified.  Detailed categorical budget
information will not be submitted with the application; budget form pages of
the application kits will not be used.  Instead, total direct costs requested
for each year will be presented.  Information, in narrative form, will be
provided only for Personnel and, when applicable, for Consortium/Contractual
Costs.  See section on APPLICATION PROCEDURES below.

Additional narrative budget justification will be required in the application
only if there is a variation in the number of modules requested. 

There will be no routine escalation for future years. In determining the total
for each budget year, applicants should first consider the direct cost of the
entire project period. Well-justified modular increments or decrements in the
total direct costs for any year of the project that reflect substantial
changes in expected future activities may be requested. For example, purchase
of major equipment in the first year may justify a higher overall budget in
the first, but not in succeeding years.

Other Support pages of the PHS 398 will not be submitted with the application. 
Information on research projects ongoing or completed during the last three
years of the principal investigator and key personnel will be provided as part
of the "Biographical Sketch."  This information will include the specific
aims, overall goals and responsibilities and should include Federal and
non-Federal support.  This information will be used by reviewers in the
assessment of each individuals qualifications for a specific role in the
proposed project.

Following peer review, information about Other Research Support will be
requested from the applicant for applications being considered for award.
Additional budget information will be requested only under special
circumstances.

This RFA is a one-time solicitation. Future unsolicited competing continuation
applications will compete with all investigator-initiated applications and be
reviewed according to the customary peer review procedures.  Responsibility
for the planning, direction, and execution of the proposed project will be
solely that of the applicant.

Research Project Grants (R01) - A research project grant application should be
designed to establish, discover, develop, elucidate, or confirm information
relating to occupational safety and health, including innovative methods,
techniques, and approaches for addressing problems.  These studies may
generate information that is immediately useful to solve problems or that will
contribute to a better understanding of the causes of work-related diseases
and injuries.

Demonstration Project Grants (R18) - A demonstration project grant application
should address the technical or economic feasibility of implementing a
new/improved innovative procedure, method, technique, or system for preventing
occupational safety or health problems.  The project should be conducted in an
actual workplace where a baseline measure of the problem will be defined, the
new/improved approach will be implemented, a follow-up measure of the problem
will be documented, and an evaluation of the benefits will be conducted.

FUNDS AVAILABLE

Approximately $7.5 million is available in FY 1999 to fund approximately 30-32
grants under this RFA.  The approximate amounts that are expected to be
available by each Institute are as follows, but the amounts may vary: NIOSH -
$5.5 million for all areas (including CDC Prevention Research funds for
intervention effectiveness research),NCI - $0.5 million, NHLBI - $1.0 million,
and NIEHS - $0.5 million.

Target amounts for the NORA priority areas are as follows: 
1.  Intervention Effectiveness Research ($1.5M)
2.  Fertility and Pregnancy Abnormalities ($0.5M)
3.  Hearing Loss ($0.5M)
4.  Exposure Assessment ($1.0M)
5.  Surveillance Research Methodology ($1.0M)
6.  Special Populations at Risk - Aging Workforce ($1.0M)
7.  Asthma and Chronic Obstructive Pulmonary Disease ($1.0M)
8.  Organization of Work: Demanding Work Schedules, Sleep Disorders, and Risk
of Occupational Illness and Injury ($1.0M)

Awards are anticipated to range up to $250,000 in total costs (direct and
indirect) per year and are expected to begin in September 1999.  Awards will
be made for a 12-month budget period within a project period not to exceed 3
years.  Only applications that are found to be of high scientific merit will
be considered for funding, and not all of the funds will be spent if there are
not enough highly meritorious applications.  Continuation awards within the
project period will be made on the basis of satisfactory progress and
availability of funds in future years.

RESEARCH OBJECTIVES

In today's society, Americans are working more hours than ever before.  The
workplace environment profoundly affects health; each of us, simply by going
to work each day, may face hazards that threaten our health and safety. 
Risking one's life or health should never be considered merely part of the
job.  In 1970, Congress passed the Occupational Safety and Health Act to
ensure Americans the right to "safe and healthful working conditions," yet
workplace hazards continue to inflict a tremendous toll in both human and
economic costs.  Employers reported 5.8 million work injuries in 1996 and
439,000 cases of occupational illness.  An average of 16 American workers die
each day from injuries on the job.  Moreover, even the most conservative
estimates find that about 137 additional workers die each day from workplace
diseases.  Additionally, in 1996 occupational injuries and deaths cost $121
billion in wages and lost productivity, administrative expenses, health care
and other costs.  This does not include the cost of occupational disease. 
These occupational injuries and diseases create needless human suffering, a
tremendous burden upon health care resources, and an enormous drain on U.S.
productivity.

In 1996, the National Institute for Occupational Safety & Health (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 þ 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 the National Occupational Research Agenda (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.  Fiscal
constraints on occupational safety and health research are increasing, making
even more compelling the need for a coordinated and focused research agenda. 

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".

The research needs identified in this RFA are consistent with the NORA but are
limited to the targeted areas below.  Potential applicants with questions
concerning the acceptability of their proposed work are encouraged to contact
program staff listed under INQUIRIES.

Applications responding to this RFA will be reviewed for their responsiveness
to the following program interests and their potential for developing
knowledge that can be used in preventing occupational diseases and injuries. 
Applicants should provide a statement about which NORA area is being addressed
and a rationale for how the proposal will contribute to the specified priority
area (this information should be placed in the "Background and Significance"
section of the "Research Plan" of the application).

Targeted NORA Priority Areas for this RFA are:

1.  Intervention Effectiveness

Many workplace prevention and intervention programs have been developed and
implemented, yet few have undergone systematic evaluation to determine their
impact on health and safety outcomes.  Evaluations of the effectiveness of
intervention efforts can provide crucial guidance and corrective feedback for
current and future occupational safety and health intervention efforts.

Research applications are sought that focus on the systematic evaluation of
the effectiveness of interventions.  Of interest are fully-developed
interventions which are ready for implementation as well as evaluations of the
effectiveness of interventions which have already been implemented.  Proposals
for comparative analyses of the effectiveness of alternate options (e.g.,
cost-effectiveness) are also solicited. 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.  Encouraged are interdisciplinary proposals which include, as
appropriate, the fullest complement possible of  outcome measures.  These
measures could include 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.)
These examples of potential health, economic, and social outcome measures, are
provided only to illustrate the range of outcomes of interest, not to
represent an exclusive listing.

Encouraged are proposals to evaluate interventions in any industry sector but
special consideration will be given to proposals to evaluate interventions in
agriculture, construction, services (especially health care), and mining.

2.  Fertility and Pregnancy Abnormalities

While more than 1,000 workplace chemicals have shown reproductive effects in
animals, for the vast majority, nothing is known about the effects in humans.
In addition, most of the 4 million other chemical mixtures in commercial use
remain untested.  Although the total number of workers exposed to potential
reproductive hazards is difficult to estimate, three-quarters of employed
women and an even greater proportion of employed men are of reproductive age.
More than half of U.S. children are born to working mothers. The vast number
of workers of reproductive age together with the substantial number of
workplace chemical, physical, and biological agents suggest that a
considerable number of workers are potentially at risk for adverse
reproductive outcomes. The inadequacy of current knowledge coupled with the
ever-growing variety of workplace exposures pose a potentially serious public
health problem.

Research applications are sought which will investigate the relationships
between occupational exposures and adverse reproductive/developmental effects
in humans.  Applicants are strongly encouraged to design studies that employ
improved exposure assessment methodologies such as biomarkers; utilize
existing data bases; and include non-occupational risk factors, such as
existing medical conditions, lifestyle factors and genetic susceptibility to
teratogens.  Effects of interest include: (1) Reduced fertility in male and
females or other indications of altered reproductive function such as changes
in hormone levels or poor semen quality; (2) Pregnancy outcomes, pre- and
postnatal development of offspring and; (3) Evidence of effects on male
reproduction such as  testicular cancer, hypospadias and cryptorchidism.

3.  Hearing Loss

NIOSH estimates that over 30 million American workers are exposed to
occupational hazards to hearing including noise and ototoxic chemicals. 
Hearing loss is the most common of occupational diseases and it is the most
preventable. In 1995 the National Institute on Deafness and other
Communication Disorders estimated that of the 28 million Americans with
hearing loss, nearly half had workplace-related noise-induced hearing loss. 
The goal of the "Healthy People 2010" is to reduce by half the incidence of
significant threshold shift due to exposure to noise at work.  To aid in
achieving this national health objective, further research in Occupational
Hearing Loss is needed.

Research applications are sought in the following areas: (1) Biological
effects of and biological response to noise and other ototoxic agents
including relationship of first- or second-hand smoke to noise induced hearing
loss, relationship of noise-induced hearing loss to  secondary risk factors
such as hypertension, head trauma, diabetes, blood lipids, and clinical
therapeutic drugs, role of genetics in determining individual susceptibility
to noise-induced hearing loss, as well as the role of free-radicals and
antioxidants in noise-induced hearing loss; (2) Investigation of new noise
control and personal protective equipment technologies such as utilization of
active noise reduction control noise at the source, incorporation of
electroacoustic systems in hearing protectors, as well as development of
methods for determining the actual noise reduction workers receive from
hearing protectors; (3) Issues for hearing-impaired workers including
susceptibility to noise-induced hearing loss for persons with pre-existing
noise- or age-related hearing loss, personal protective equipment used for
noise reduction and as hearing aids, aural rehabilitation for the
hearing-impaired worker who must continue to work in noise, as well as
defining audiometric and performance specifications for hearing-critical jobs;
(4) Effects of noise on speech communication including accuracy of
communication in terms of expected outcomes or need to repeat messages, safety
of workers who must work and communicate in noise; (5) Health communications
research including methods for delivering training and motivation to
noise-exposed workers; and (6) Surveillance and intervention research
including evaluation methods to study  existing compliance-driven hearing
conservation programs to determine their effectiveness in preventing
noise-induced hearing loss, as well as development and study of longitudinal
audiometric databases for persons not exposed to hearing hazardous agents such
as noise and other chemical and physical agents.  

4.  Exposure Assessment

A primary research focus for both occupational and environmental health
concerns is to better understand the health effects associated with exposures
to toxic and hazardous substances in the environment.  Precise methods for
exposure assessment are critical to measuring body burden of environmental
exposures in environmental and occupational epidemiologic studies and risk
assessment.  Exposure assessment is a rapidly evolving, multi-disciplinary
research activity central not only to defining exposure - response
relationships in epidemiologic studies but also to deciding whether, and how,
to use resources for reducing workplace and environmental exposures.  Methods
for substances that may have high dose exposures in the workplace, but are
also found, possibly at lower levels, in the general environment are of
interest as are methods for determining take-home exposures (which may be
important for children and spouses), and other environmental sequellae of
chemicals and other exposures.

Research applications are sought which address: (1) Development of
sufficiently precise exposure assessment methodologies to support valid
epidemiologic studies in complex environments.  This includes considerations
related to the structure and content of occupational safety and health
exposure assessment databases (e.g., types of data included, the functionality
and relationships necessary to complement typical industrial hygiene work
flows, and data collection and analysis),  characterizations of individual
work practices and tasks, development of  modeling strategies and statistical
methods for data analysis, and research which addresses the utility of these
data bases in understanding community risks from occupational exposures; (2)
Development of  practical and valid  measurement techniques that can be
applied at reasonable cost for assessing workplace chemical, biological, and
physical hazards.  Of particular interest are methods addressing microbial
contamination and worker exposure to microbes and microbial toxins (both non-
aerosolized microbes and bioaerosols) which consider issues such as sample
transport, stability and viability, real-time (on-site) determination of
microbial contamination, and issues related to the identification of exposures
of bioaerosol mixtures; (3) Development  and/or evaluation of methods for
appropriate biomarkers of exposure and total dose using samples obtained by
relatively noninvasive methods.  These would include methods to evaluate
dermal exposures,  and methods that can measure exposure to heterogeneous
mixtures or classes of compounds (e.g., chlorinated solvents, mixtures of PCB
congeners).  Use of occupationally exposed cohorts to validate biomarkers of
exposure to environmentally relevant chemicals is encouraged; (4) Development
and evaluation of  portable, direct-reading instrumentation for on-site
determinations of chemical, biological and physical hazards.  Of particular
need are devices for measuring low level exposures which could provide data
useful in addressing dose-response aspects of occupational risk; and (5)
Transfer of strategies from workplace assessment to environmental assessment,
i.e., the application of methods which measure worksite exposures at high
concentration levels for the determination of lower level exposures to
environmental air pollutants.

5.  Surveillance Research Methodology

Occupational safety and health surveillance programs collect, analyze, and
disseminate information about hazards, illnesses, and injuries in the
workplace.  Surveillance systems describe the presence of hazards and where
occupational injuries or illnesses are occurring, how frequently they occur,
whether they are increasing or decreasing, and whether prevention efforts have
been effective.  The occupational and public health community rely on
surveillance information to set research and prevention priorities.  Gaps in
knowledge, inadequate hazard/exposure assessment methods, and untimely
recognition and reporting are barriers to effective occupational safety and
health.

Surveillance methods research applications are sought in the following areas:
(1) Development and/or evaluation of methods to characterize workplace
hazards, exposures, and risk factors to promote the early recognition and
prevention of workplace illness or injury; (2) Methods for effective exposure
monitoring, medical screening, and disease and injury surveillance of worker
populations at risk for important work-related conditions and injuries, such
as musculoskeletal disorders, irritant contact dermatitis, asthma, pesticide
poisoning, hearing loss, bladder cancer, heat stress, and radiation effects;
(3) Methods to evaluate the prevalence of and estimate the impact of under-
recognition and under-reporting of workplace illness and injury; (4) Methods
to improve enumerating the "population-at-risk" for illness and injury
surveillance, and methods estimating "exposure time"  concerning machine use
hazards and other time-dependent injury risks; (5) Methods to identify,
evaluate, and monitor workplace hazards, exposures, illness, injury, and
related-risk factors among small scale businesses, independent contractors,
service sector part-time or occasional labor, and vulnerable (e.g., workers
less than 16 years or the legal age of consent, and migrant labor) working
populations; (6) Methods to adapt the use of insurance industry data (e.g.,
workers' compensation, health and medical care) to promote the early
recognition, reporting, and prevention of workplace illness and injury; and
(7) Methods for utilizing information technologies for the development of
active injury, illness, and hazard surveillance systems for use at the
employer level.

6.  Special Populations at Risk - Aging Workforce

This announcement targets a subset, older workers, of the special populations
included in this NORA priority area.  The median age of the US workforce is
increasing as a result of the aging of the post World War II "baby boom"
generation.  This combined with a gradual increase in life expectancy has led
to an increasing percentage of older workers either remaining in the workforce
or reentering the workforce as contingent or part-time workers.  The aging of
the workforce raises several important public health questions including how
working affects the aging process, how aging affects working capacity and
occupational disease susceptibility, and how the health of older employees is
affected by the recent changes in the nature of work, including the
introduction of new technologies, adoption of new forms of work organization
and other organizational changes such as downsizing and restructuring.

Research proposals  are invited which address the following areas: (1)
Demographics of work and the health of workers by age.  Of interest are
proposals which address the development and validation (using either new or
existing databases) of methods of determining where older workers are employed
and the occupational risk factors to which they are exposed, including
parameters such as the distribution by industry and  jobs classification,
geographic regions and  nature of employment (full-time, part-time,
contingent) as well as their demographic distribution such as by age group,
gender, race/ethnicity and workforce size. Analyses of these data might also
address the distribution of important work-related and non work-related
diseases by age group, gender/ethnicity and employment with a focus on
determining priority areas where the impact of the aging workforce will be
most significant.  Also of interest are proposals which address methods of
generating priority areas for future intervention and research based upon the
analysis of this statistical data.  (2) The characteristics of work/workplace
that facilitate or impede the productivity of older workers and their ability
to stay in the workplace.  Prior research has focused mainly on measuring
changes in work capacity as workers age; the ability of aging workers to
remain in a job or workplace also depends upon a combination of physical,
mental, and social characteristics.  Of interest are proposals which develop
and utilize an integrated approach to examining the relationships between
these characteristics and the aging worker's ability to remain in the
workforce.  Also of interest are proposals which focus on the interdependence
between work organizations and individuals and the consequences of adapting
work to the needs and characteristics of the older worker, as well as the
health and safety implications for older workers of recent workplace changes
such as technological innovation, downsizing, and new forms of work
organization. 

7.  Asthma and Chronic Obstructive Pulmonary Disease (COPD)

Concurrent with the rise in asthma in the general U.S. population, work-
related asthma has become the most commonly reported occupational lung
disease, resulting in considerable disability, economic loss, and human costs. 
Further investigation is required to improve the understanding of asthma that
develops in response to exposures in work environments.  Specific areas of
interest include, but are not limited to, definition of the relationships
between respiratory, skin, and mucous membrane exposures (to sensitizers,
irritants, and other adjuvant conditions) and health outcomes of relevance to
asthma (immunologic sensitization, airway hyper-responsiveness, airway
inflammation, broncho-constriction, and asthma symptoms).  Of interest are
proposals that address: (1) Relationships between occupational exposures and
asthma-related responses, including the inflammatory and immunologic
mechanisms and possible related genetic markers, relevant to development,
progression, regression of, or protection from asthma in relation to work
exposures, such as cellular migration and proliferation, cellular functions,
and cytokine cascades; (2) Development and/or application of novel approaches
to characterizing and evaluating exposures and/or exposure kinetics using
methodologies that may be applicable to exposure assessment, health screening,
or epidemiologic studies in the workplace; (3) Methods for prospectively
identifying substances that are likely to pose a risk of asthma (prior to
their introduction into the workplace) and characterizing their
immunotoxicology.

Many occupational exposures (both by themselves or in combination with
smoking) are known to cause COPD.  One estimate of the proportion of COPD
attributable to occupational exposure in the general population is 14 percent. 
Further investigation is required to improve 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 accelerate lung function loss.  Specific areas of interest
include, but are not limited to, the relationship between various work
environments, accelerated lung function loss, and the subsequent development
of COPD;  documentation of beneficial effects of substantially reducing or
eliminating exposure to occupational respiratory hazards; evaluation of
workplace medical screening/surveillance programs or data from on-going and
completed population-based studies; mechanisms by which certain occupational
exposures cause COPD, and animal models of occupational COPD.

8.  Organization of Work: Demanding Work Schedules, Sleep Disorders, and Risk
of Occupational Illness and Injury

This announcement targets a part of the NORA priority area Organization of
Work.  Demanding work schedules involving night and rotating shift work,
extended workdays, overtime, and irregular work schedules affect 20% of U.S.
workers.  The most immediate detrimental effect of such schedules is disturbed
sleep and disrupted circadian rhythms leading to excessive fatigue, reduced
performance and loss of alertness.  Health and safety outcomes potentially
associated with these disruptions include: accidents and injuries, operational
errors, miscarriage, and cardiovascular and gastrointestinal morbidity. 
However, additional information is needed to link work schedule parameters to
sleep and circadian rhythm disruption, and to examine how these factors
interact with other work demands and workplace stressors to compromise health
and safety.  

Research applications are sought in the following areas: (1) Broad
epidemiologic studies to determine the association of sleep disorders with
work-related health and safety risks; (2)Applied research to evaluate the
scope and consequences of sleepiness and to develop new approaches to prevent
impaired performance in the workplace and during waking hours; (3) Focused
workplace demonstration projects aimed at improving the quality and quantity
of sleep and decreasing circadian rhythm disruption by re-designing work
schedules, minimizing workplace stressors, and improving other aspects of work
organization; (4) Approaches for shift workers to reduce the likelihood of
excessive sleepiness and drowsy driving using a combination of alertness
management approaches; (5) The biological and behavioral factors that may
contribute to individual tolerance to shift work; (6) Studies to better
understand and evaluate the utility of various interventions (e.g., bright
light treatments and melatonin) to prevent and manage sleepiness to help shift
workers adapt and overcome circadian phase disruption and improve productivity
and safety; (7) Understanding of the role of sleep deficits resulting from
lifestyle and work schedules; (8) The degree and nature of sleepiness
associated with different amounts and rates of sleep loss and appropriate
countermeasures to increase productivity and safety in a variety of work
settings; and, (9) Development of new pharmacological agents to increase
alertness and advanced technologies to objectively detect and monitor
sleepiness.

SPECIAL REQUIREMENTS

Human Subjects

If a project involves research on human subjects, assurance (in accordance
with Department of Health and Human Services Regulations, 45 CFR Part 46) of
the protection of human subjects is required.  In addition to other applicable
committees, Indian Health Service (IHS) institutional review committees also
must 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 that portion of the project applicable to
it.  Unless the grantee holds a Multiple Project Assurance, a Single Project
Assurance is required, as well as an assurance for each subcontractor or
cooperating institution that has immediate responsibility for human subjects. 
The Office for Protection from Research Risks (OPRR) at the National
Institutes of Health (NIH) negotiates assurances for all activities involving
human subjects that are supported by the Department of Health and Human
Services. 

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 for the Protection
from Research Risks (OPRR) 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). 

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the Centers for Disease Control and Prevention (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.

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.

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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

LETTER OF INTENT

Prospective applicants are asked to submit, by April 19, 1999, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities of
other key personnel and participating institutions, and the number and title
of the RFA in response to which the application may be submitted.  Although a
letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows
staff of the participating Institutes to estimate the potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to:

Roy M. Fleming, Sc.D.
Research Grants Program
National Institute for Occupational Safety and Health
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-30
Atlanta, GA  30333
Telephone:  (404) 639-3343
FAX:  (404) 639-4616
Email:  rmf2@cdc.gov

APPLICATION PROCEDURES

Applicants must use Form PHS 398 (rev. 4/98).  Application kits are available
at most institutional offices of sponsored research and may be obtained from
the Division of Extramural Outreach and Information Resources, National
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910,
telephone 301/435-0714,  Email: grantsinfo@nih.gov.  Application kits are also
available at: grants.nih.gov/grants/forms.htm.

BUDGET INSTRUCTIONS

The total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398 application
instructions described below:

o  FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period. Items 8a and 8b should be completed indicating the Direct and Total
Costs for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required and
will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page.
(See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.)
At the top of the page, enter the total direct costs requested for each year.

o  Under Personnel, List key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the nearest
$1,000. List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and the role
on the project. Indicate whether the collaborating institution is foreign or
domestic. The total cost for a consortium/ contractual arrangement is included
in the overall requested modular direct cost amount.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for all
key personnel, following the instructions below. No more than three pages may
be used for each person. A sample biographical sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page; - List current
position(s) and then previous positions; - List selected peer-reviewed
publications, with full citations; - Provide information, including overall
goals and responsibilities, on research projects ongoing or completed during
the last three years.

o  CHECKLIST - This page should be completed and submitted with the
application.  If the F&A rate agreement has been established, indicate the
type of agreement and the date. It is important to identify all exclusions
that were used in the calculation of the F&A costs for the initial budget
period and all future budget years.

o  The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.

Applicants not conforming to these guidelines will be considered unresponsive
to this RFA and will be returned without further review.

The RFA label available in the PHS 398 application form must be affixed to the
bottom of the face page of the application.  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, typewritten original, including the checklist, and three
signed, clear, and single sided photocopies 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 Dr. Roy M. Fleming at the address under LETTER OF INTENT.

Applications must be received by June 10, 1999. If an application is received
after that date, it will be returned to the applicant without review.  The
Center for Scientific Review (CSR) 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,  The CSR will
not accept any application that is essentially the same as one already
reviewed.  This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness and
responsiveness (applicants should clearly indicate which priority area of this
RFA is being addressed by their proposal) and will be assigned to the
appropriate sponsoring federal agency or institute for funding consideration. 
Applications determined to be incomplete or unresponsive to this RFA will be
returned to the applicant without further consideration.  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.

Applications that are complete and responsive to the RFA will be reviewed for
scientific and technical merit by an initial review group convened by NIOSH. 
Reviewers will identify those applications with the highest scientific merit,
which generally comprise the top half of applications reviewed.  Those
applications will be discussed fully and assigned a priority score between 100
and 300 (100 is the best possible score).  For all other applications, there
will be a limited discussion and they will not be scored.  Notification of the
scientific review results will be sent to the applicants after the initial
review.

Following the initial review, applications will receive a secondary review for
programmatic importance (for applications assigned to NIH Institutes, the
review will be conducted by the appropriate Council).

Review Criteria

1.  Significance.  Does this study address an important problem? 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?

2.  Approach.  Are the conceptual framework, design, 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?

3.  Innovation.  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative? Does the project challenge or advance
existing paradigms, or develop new methodologies or technologies?

4.  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)?

5.  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 evidence of institutional
support?

The initial review group will also examine the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders,
minorities and their subgroups, and children as appropriate for the 
scientific goals of the research and plans for the recruitment and retention
of subjects; the provisions for the protection of human and animal subjects;
and the safety
of the research environment.

The personnel category will be reviewed for appropriate staffing based on the
requested percent effort. The direct costs budget request will be reviewed for
consistency with the proposed methods and specific aims.  Any budgetary
adjustments recommended by the reviewers will be in $25,000 modules.  The
duration of support will be reviewed to determine if it is appropriate to
ensure successful completion of the requested scope of the project.

Demonstration grant applications will be reviewed additionally on the basis of
the following criteria:

o  Degree to which the project will document baseline measures and evaluate
the benefits of an intervention approach.

o  Degree to which the project can be expected to yield or demonstrate results
that will be useful and desirable on a national or regional basis.

o  Documentation of cooperation from industry, unions, or other participants
in the project.

Review Criteria for Programmatic Importance are as follows:

o  Magnitude of the problem in terms of numbers of workers affected.

o  Severity of the disease or injury in the worker population.

o  Usefulness to applied technical knowledge in the identification,
evaluation, or control of occupational safety and health hazards on a national
or regional basis.

o  Propensity to improve understanding of the pathophysiology (includes
biomechanics), diagnosis, treatment, and prevention of adverse health or
safety outcomes caused by occupational exposures.

AWARD CRITERIA

Final funding decisions are based on the recommendations of the initial
(technical merit) and secondary (programmatic importance) reviews, balance of
awards across areas of programmatic interest in this RFA, and availability of
funds.  Awards are expected to begin in September 1999, although some awards
may not begin until FY 2000.

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 Announcements can be found on the CDC HomePage (www.cdc.gov) under the
"Funding" section.  This RFA can also be found on the NIOSH HomePage
(www.cdc.gov/niosh) under "Extramural Program."

Direct inquiries regarding programmatic issues to:

Roy M. Fleming, Sc.D.
Research Grants Program
National Institute for Occupational Safety and Health
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-30
Atlanta, GA  30333
Telephone:  (404) 639-3343
FAX:  (404) 639-4616
Email:  rmf2@cdc.gov

Kumiko Iwamoto, M.D., Dr.P.H.
Epidemiology and Genetics Research Program
National Cancer Institute
6130 Executive Boulevard, Room 535
Bethesda, MD  20892-7395
Telephone:  (301) 435-4911
FAX:  (301) 402-4279
Email:  ki6n@nih.gov

Gail Weinmann, M.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10018, MSC 7952
Bethesda, MD  20892
Telephone:  (301) 435-0202
FAX:  (301) 480-3557
Email:  weinmang@gwgate.nhlbi.nih.gov

Sidney M. Stahl, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Room 533
Bethesda, MD  20892
Telephone:  (301) 402-4156
FAX:  (301) 402-0051
Email:  sidney_stahl@nih.gov

Amy Donahue, Ph.D.
Hearing and Balance/Vestibular Sciences Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Suite 400C, MS-7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-3458
FAX:  (301) 402-6251
Email:  amy_donahue@nih.gov

Gwen W. Collman, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-21
Research Triangle Park, NC  27709
Telephone:  (919) 541-4980
FAX:  (919) 541-4937
Email:  collman@niehs.nih.gov

Direct inquiries regarding grants management matters to:

Joanne Wojcik
Procurement and Grants Office
Centers for Disease Control and Prevention
2920 Brandywine Road, MS-E13
Atlanta, GA  30341-4146
Telephone:  (770) 488-2717
FAX:  (770) 488-2777
Email:  jcw6@cdc.gov

Mr. William Wells
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800, ext. 250
FAX:  (301) 496-8601
Email:  wellsw@gab.nci.nih.gov

Mr. William Darby
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 7128
Bethesda, MD  20892-7128
Telephone:  (301) 435-0144
FAX:  (301) 480-3310
Email:  william_darby@nih.gov

Mr. David Mineo
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-22
Research Triangle Park, NC  27709-2233
Telephone:  (919) 541-1373
FAX:  (919) 541-2860
Email:  mineo@niehs.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.262 NIOSH; 93.393 NCI; 93.837, 93.838, and 93.839 NHLBI; 93.866 NIA; 93.173
NIDCD; and 93.113 and 93.115 NIEHS.  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.

The CDC and NIH strongly encourage all grant and contract recipients to
provide a smoke-free workplace and promote the non-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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