[Federal Register Volume 63, Number 51 (Tuesday, March 17, 1998)]
[Notices]
[Pages 13051-13057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6869]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Institutes of Health
[Announcement 98044]
Implementation of the National Occupational Research Agenda;
Notice of Availability of Funds for Fiscal Year 1998
Introduction
The Centers for Disease Control and Prevention (CDC) and the
National Institutes of Health (NIH) announce that grant applications
are being accepted for research related to some of the priority areas
identified in the National Occupational Research Agenda (NORA) that is
described in the Background section. Three types of grants will be
supported: traditional research projects, demonstration projects, and
pilot studies (see MECHANISMS OF SUPPORT section).
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 announcement is related to the priority areas of
``Occupational Safety and Health'' and ``Unintentional Injuries.'' (For
ordering a copy of ``Healthy People 2000,'' see the section Where To
Obtain Additional Information.)
This announcement is jointly sponsored by (1) the National
Institute for Occupational Safety and Health (NIOSH) in CDC, (2) the
National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS) in the National Institutes of Health (NIH), (3) the National
Institute of Environmental Health Sciences (NIEHS) in NIH, and (4) the
National Heart, Lung, and Blood Institute (NHLBI) in NIH. The portion
of this initiative dealing with older workers is also of interest to
the National Institute on Aging (NIA) in NIH.
Authority
This program is authorized under the Public Health Service Act, as
amended,
[[Page 13052]]
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.
Smoke-Free Workplace
CDC and NIH strongly encourage 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.
Eligible Applicants
Eligible applicants include domestic and foreign non-profit and
for-profit organizations, universities, colleges, research
institutions, and other public and private organizations, including
State and local governments, and small, minority and/or woman-owned
businesses.
Note: Effective January 1, 1986, 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 shall not
be eligible to receive Federal funds constituting an award, grant
(cooperative agreement), contract, loan, or any other form.
Availability of Funds
Approximately $8.0 million is available in fiscal year (FY) 1998 to
fund approximately 45-50 grants. The approximate amounts that are
expected to be available by each Institute are: NIOSH--$5.0 million,
NIAMS--$1.0 million, NIEHS--$1.0 million, NHLBI--$1.0 million.
Target amounts for the NORA priority areas are as follows:
1. Occupational irritant contact dermatitis (approximately $1.0M).
2. Work-related musculoskeletal disorders, traumatic injuries,
indoor environment, and asthma and chronic obstructive pulmonary
disease (COPD) (approximately $3.0M).
3. Special populations at risk--nature and magnitude of the special
risk factors experienced by older and/or minority workers
(approximately $1.0M).
4. Social and economic consequences of workplace illness and injury
and health services research (approximately $1.0M).
5. Intervention effectiveness research--the evaluation of existing
or new interventions for work-related musculoskeletal disorders,
traumatic injuries, asthma and COPD and other occupational risks via
changes in work organization factors, through the implementation of
control technology or other worker protection techniques (approximately
$2.0M).
Awards are anticipated to range up to $250,000 in total costs
(direct and indirect) per year for traditional research and
demonstration projects, and up to $50,000 in direct costs for pilot
studies.
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.
The amount of funding available may vary and is subject to
availability of funds. Awards are expected to begin in September 1998,
although some awards may not begin until FY 99. Awards will be made for
a 12-month budget period within a project period not to exceed 3 years
for traditional research and demonstration projects, and 2 years for
pilot studies.
Continuation awards within the project period will be made on the
basis of satisfactory progress and availability of funds.
Use of Funds
Restrictions on Lobbying
Applicants should be aware of restrictions on the use of HHS funds
for lobbying of Federal or State legislative bodies. Under the
provisions of 31 U.S.C. 1352 (which has been in effect since December
23, 1989), 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, the FY 1998 Department of Labor, Health and Human
Services, and Education, and Related Agencies Appropriations Act (Pub.
L. 105-78) states in Section 503 (a) and (b) that no part of any
appropriation contained in this Act shall be used, other than for
normal and recognized executive-legislative relations, 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 legislature, except in presentation to the
Congress or any State legislature itself. No part of any appropriation
contained in this Act 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 legislature.
Background
In 1970, Congress passed the Occupational Safety and Health Act
``to assure so far as possible every working man and woman in the
Nation safe and healthful working conditions.'' In the years since
then, substantial progress has been made in improving worker
protection. Much of this progress has been based on actions guided by
occupational safety and health research. However, workplace hazards
continue to inflict a tremendous toll in both human and economic costs.
Employers reported 6.3 million work injuries and 515,000 cases of
occupational illnesses in 1994. In 1995, occupational injuries alone
cost $119 billion in lost wages and lost productivity, administrative
expenses, health care, and other costs. This figure does not include
the costs of occupational diseases. Research is needed to advance the
scientific base of knowledge necessary to define optimal strategies for
ensuring the safety and health of all workers.
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--
not only for NIOSH, but also for the entire occupational safety and
health community. The Agenda identifies 21 research priorities and
reflects consideration of both current and emerging needs. The priority
areas are not ranked because each is considered to be of equal
importance. Because the funding resources available for this special
announcement are limited, both internal and external partners have
recommended that only a subset of the priority areas be targeted as
initial areas of emphasis in order to have a meaningful impact in any
area. It is expected that, in future years, the remaining NORA
priorities will receive similar, much-deserved attention.
Purpose
The purpose of this grant 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
[[Page 13053]]
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.
Mechanisms of Support
The types of grants supported under this announcement are as
follow:
1. 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 readily available to solve
problems or contribute to a better understanding of the causes of work-
related diseases and injuries.
2. 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.
3. Pilot Study Grants (R03)
A pilot study is a preliminary evaluation for the purpose of
developing the foundation for a future, more comprehensive study. Thus,
a pilot study might test feasibility, collect initial data, refine
methodology, or evaluate critical factors that would influence the
ability to conduct a larger study. An application should contain a
clear description of how the pilot study could form the basis for
preparing a research proposal that would be submitted for competitive
review, in the future, if the results of the pilot study are promising.
The application should include only the following sections of the PHS
398 application form: face page (in item 2, place ``NORA Pilot
Study''), abstract, budget, key person biosketches, aims, background,
study plan, and human or animal subject matters. There is a 15 page
limit for the aims, background, and study plan, not including
references. The budget for an entire pilot study is limited to $50,000
in direct costs for a period of up to two years.
Programmatic Interest
The research needs identified in this announcement are consistent
with the NORA developed by NIOSH and partners in the public and private
sectors to provide a framework to guide occupational safety and health
research in the next decade towards topics which are most pressing and
most likely to yield gains to the worker and the nation. The Agenda
identifies 21 research priorities. The NORA document is available
through the NIOSH Home Page at http://www.cdc.gov/niosh/nora.html.
Potential applicants with questions concerning the acceptability of
their proposed work are strongly encouraged to contact the technical
information personnel listed in this announcement in the section WHERE
TO OBTAIN ADDITIONAL INFORMATION.
Applications responding to this announcement will be reviewed by
staff for their responsiveness to the following program interests and
their potential for developing knowledge that can be used in preventing
occupational diseases and injuries.
Targeted NORA Priority Areas for this announcement are as follow:
1. Occupational Irritant Contact Dermatitis. This announcement
targets a part of the NORA priority area, Allergic and Irritant
Dermatitis. In 1993, the Bureau of Labor Statistics (BLS) data
estimated an incidence of 76 cases of occupational skin disorders
(OSDs) per 100,000 U.S. workers, making OSDs the most common non-
trauma-related occupational disease affecting workers in many different
occupations. Irritant contact dermatitis (ICD) is the most common form
of dermatitis, usually resulting from reactions to chemical irritants
such as solvents and cutting fluids. The goal of the ``Healthy People
2000'' is to reduce OSDs to an incidence of not more than 55 per
100,000. To aid in achieving this national health objective, further
research in ICD is needed.
Research applications are sought in the following areas: (1)
methods for identifying irritants prior to introduction into the
workplace; (2) pathophysiology of ICD; (3) the genetic basis of
susceptibility; (4) the influence of environmental factors on ICD; (5)
the relationship of ICD to allergic contact dermatitis; (6) methods to
identify skin changes that precede overt clinical disease; (7) risk
factors for initiation and/or chronicity of ICD; (8) methods for
measuring skin exposure and skin deposition; (9) methods for assessing
percutaneous penetration and evaluating skin barrier function; (10)
intervention design and evaluation; (11) enhanced membrane/film
development for skin protection; (12) improved procedures for testing
chemical protective clothing (CPC) field performance; and, (13) the
effectiveness of CPC and/or barrier creams. The ultimate goal is the
primary, secondary, and tertiary prevention of ICD.
2a. Work-Related Musculoskeletal Disorders. Thirty-two percent of
the injuries and illnesses recorded in the BLS survey in 1994 involved
musculoskeletal (MS) injuries or disorders and resulted from over-
exertion or repetitive motion. In the United States (U.S.), back
disorders account for 27 percent of all nonfatal occupational injuries
and illnesses involving days away from work. Musculoskeletal disorders
of the upper extremities (such as carpal tunnel syndrome and rotator
cuff tendinitis) due to work factors are common and occur in nearly all
sectors of the economy. More than $2 billion in workers' compensation
costs are spent annually on these work-related problems.
Research applications are sought in the following areas: (1)
Development and validation of models of nonspecific or specific
musculoskeletal disorders which predict biomechanical, biochemical or
structural changes in soft tissues resulting from repetitive exposure
to physical loads. (An example of this type of research would be to
develop an animal model for investigating the effects of repetitive use
of tendons, ligaments, and synovium); (2) age and gender differences in
the biochemistry and/or biomechanical responses of musculoskeletal soft
tissues to injury and repair; (3) development and validation of
exposure-assessment methods directed toward existing prevention
activities in the private sector, State or local government agencies
and for future epidemiologic studies of work-related musculoskeletal
disorders; (4) epidemiological studies to determine exposure-response
(injury/disorder) relationships between work-related musculoskeletal
disorders and physical exposures as well as work organization
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factors. These studies should include both work and non-work exposure
and modifying factors; (5) evaluation of existing or new interventions
directed at either primary, secondary, or tertiary prevention of common
work-related musculoskeletal disorders. (Projects directed at secondary
or tertiary prevention should focus on reducing lost work time and
preventing future injuries or disorders, or their recurrence); and (6)
evaluation of the effectiveness and outcomes of preventive, diagnostic
and medical treatments (includes non-operative, operative,
rehabilitative and alternative medicine treatments) for work injuries
and illnesses of the musculoskeletal system.
2b. Traumatic Injuries. Injury exacts a huge toll in U.S.
workplaces. On an average day, 16 workers are killed and more than
17,000 are injured. The leading causes of occupational injury
fatalities over the period 1980 to 1992 were motor vehicles, machines,
homicides, falls, electrocutions, and falling objects. The leading
causes of the nonfatal injuries were overexertion, contact with objects
or equipment, and falls.
Relatively good information is available on the overall burden of
work injuries including the industries and occupations where they occur
most frequently and with greatest severity. The challenge is to move
beyond this broad understanding to specific strategies that address the
complex interplay between machines, tools, and behavioral and
environmental factors that cause injuries at a worksite. Research
applications are sought which will: (1) Conduct etiological research
into risk factors or contributors to occupational injuries; (2) advance
knowledge of the interactions between human performance/human
limitations and workplace, machine and equipment design to remove the
possibility of unsafe actions; (3) develop models and simulations for
the safe design, operation and maintenance of workplaces and equipment;
(4) develop cost/benefit analysis models of various prevention
strategies; and, (5) develop simple cost-effective injury prevention
models and guidelines for application by safety and health
practitioners in the field.
2c. Indoor Environment. Traditionally, indoor nonindustrial
occupational environments have been considered clean and relatively
free of exposures to substances which pose a health hazard. In the last
20 years, however, reports of symptoms and other health complaints
related to these indoor environments have been increasing. More than
half of the U.S. workforce is employed indoors, and estimates of the
proportion of indoor workers affected by these problems range up to 30
percent. Among the requests received annually by NIOSH for occupational
health investigations, the proportion related to indoor nonindustrial
environments has increased dramatically, from 2 percent in 1980 to 40
percent in recent years.
Research applications are sought in the following areas: (1) Causes
or prevention of health effects from indoor work environments,
including the transmission of communicable respiratory diseases, asthma
or other allergic diseases, or acute symptoms from unknown causes or
multiple chemical sensitivities. (Strategies of particular interest
include intervention designs to evaluate the effectiveness of
environmental controls or of following current practice standards for
building operation and improving relevant exposure (microbiological or
chemical) assessments); (2) creating practical tools to help the
building sector create healthier indoor environments, such as new or
improved measurement tools for exposure assessment, and scientifically-
validated guidelines to help assure healthy indoor environments (e.g.,
for design, operation, and maintenance actions, or through building
performance); and (3) estimating health and other social and economic
consequences (such as health care costs, absenteeism, and productivity
losses) resulting from adverse effects of indoor environments, as well
as potential benefits of improved indoor environments.
2d. Asthma and Chronic Pulmonary Obstructive Disease. Asthma and
Chronic Obstructive Pulmonary Disease (COPD) are leading respiratory
diseases in the U.S. and major causes of morbidity and mortality.
Although both diseases have nonoccupational causes, workplace exposures
also contribute to their development, persistence, and exacerbation.
More research is needed to guide efforts to prevent and reduce the
occupational contribution to these diseases.
Research applications are sought in the following areas: (1)
Estimation of the proportions of COPD and/or asthma in the adult
general population that are attributable to occupational causes,
including industry- and agent-specific attributable fractions; (2) risk
factors for developing asthma or COPD in response to occupational
agents, which might include attention to exposure-response
relationships, novel means of characterizing exposure or exposure
kinetics, host factors, modifying factors (such as smoking or impaired
lung function), and conditions necessary for occupational asthma to
completely resolve; (3) methods for identifying substances that may
cause asthma prior to their introduction into the workplace; (4)
application of methodological approaches to assessing the burden of
occupational asthma/COPD with attention to healthy worker effect; (5)
mechanisms and pathophysiology of asthma or COPD caused by occupational
exposures; and (6) approaches useful for effective screening and
surveillance of worker populations at risk for airways diseases caused
by occupational exposure.
3. Special Populations at Risk. Occupational hazards are known to
be distributed differentially, and workers with specific biologic,
social and/or economic characteristics are more likely to have
increased risks of work-related diseases and injuries. This
announcement targets a subset--older workers and racial ethnic
minorities--of the special populations included in the NORA priority
area. The relative proportions of these special populations within the
workforce is increasing. It is estimated that, by the year 2000,
approximately 39 percent of the projected U.S. population of 275
million will be a member of a minority population (American Indian or
Alaska Native, Asian, Black or African American, Native Hawaiian or
Other Pacific Islander, and Hispanic or Latino.) The median age of the
U.S. workforce is rising as a result of the aging of the ``baby boom''
generation, an increasing percentage of older workers remaining in the
workforce, as well as an increasing number of older workers reentering
the workforce after retirement. As a result, between 1992 and 2005, the
number of workers aged 55 and older is projected to increase by 38
percent.
Research applications are sought in the following areas: (1) The
nature and magnitude of risks to minority and older workers, including
the social and biologic factors (e.g., biochemical susceptibility) that
may influence a worker's risk for injury or disease; (2) the incidence
and mechanisms of diseases and injuries in minority and older worker
populations; (3) the interdependence between work organizations and
individuals and the consequences of adapting work (flex-place, flex-
time, job sharing, retraining, reengineering, etc.) to the needs and
capacities of these special populations; and, (4) the characteristics
of the work/workplace that facilitate or impede the productivity of
older workers and the
[[Page 13055]]
ability of older workers to stay in the workforce.
4a. Social and Economic Consequences of Workplace Illness and
Injury. Occupational injuries and illnesses remain a leading cause of
morbidity, mortality, and economic loss in the United States. The
annual costs to employers for workers' compensation increased from $2.1
billion in 1960 to $60 billion by 1992. In addition to the direct costs
such as those for health care, employers also incur numerous indirect
costs including those for additional hiring and training and disruption
of work processes. Other costs are borne by injured workers and their
families through reduced income, depletion of savings and increased
expenditures and by the community through increased use of social
services and cost shifting between health and social service agencies.
Leigh, et al. (Leigh, J.P. et al., Occupational Injury and Illnesses in
the United States, Arch. Intern. Med., 157, 1557-68, 1997) estimated
that, for 1992, the total direct and indirect costs associated with
occupational injuries and diseases were $171 billion annually, but
noted that these estimates were likely to be low in part due to the
lack of data for a number of the associated indirect costs.
Research applications are sought in the following areas: (1)
Measures of total economic costs (direct and indirect) and non-economic
costs borne by injured workers and their families, by employers; and by
non-occupational community, State and local government services; and
(2) evaluation of the economic benefit of interventions (e.g.,
ergonomic work system and task redesign) including occupational health
service interventions, and assessment of their contribution to the cost
of work-related illness and injury at both the service system level
(e.g., managed care in compensation services) and service component
level (e.g., cost-effectiveness of different clinical treatments for
back pain).
4b. Health Services Research. Despite the large burden and cost of
work-related morbidity and mortality, relatively little is known about
the structure and functioning of occupational health services.
Occupational health services (OHS) research includes evaluation of both
service components and delivery systems, including distribution and
coverage, access, appropriateness, acceptability, utilization, equity,
quality, organization, policy and planning, management, financing,
productivity, effectiveness and efficiency, and impacts on health
needs, health status and occupational hazards.
Research applications are sought in the following areas: (1)
Descriptions of the state, the distribution of types, and the
prevailing trends in the provision of OHS for the prevention, treatment
and rehabilitation of work-related illness and injury, and the
interactions of OHS with other parts of the health care system; (2)
evaluation, in terms of health and vocational outcomes (e.g., return to
work), of different occupational health services and systems (e.g.,
managed care versus fee-for-service compensation services), and service
interventions (e.g., different treatments for back pain); and (3)
evaluation of the effectiveness (through clinical trials, observational
research, and clinical trials) of the effectiveness and efficiency of
clinical therapeutic interventions and rehabilitation modalities for
occupational diseases and injuries.
5. Intervention Effectiveness Research. Many workplace prevention
and intervention programs have been developed and implemented in
workplaces, 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 health and
safety (OSH) intervention efforts. Evaluation research, whether
descriptive or experimental, can provide a firm base of evidence for
what works, what does not, and why, and assure better use of limited
resources in workplace implementations of preventive and control
strategies. This announcement targets intervention efforts addressing
work-related traumatic injuries, musculoskeletal disorders, asthma and
COPD as well as the implementation of engineering controls, use of
personal protective equipment (PPE) and/or changes in the organization
of work systems or tasks.
Research applications are sought which focus on the systematic
evaluation of (1) the effectiveness of intervention efforts addressing
musculoskeletal disorders, traumatic injuries, and work-related asthma
and COPD; (2) the practicality and usability of specific control
strategies, technologies and/or PPE in the elimination or reduction of
hazards; (3) the identification of critical factors for implementing
and conducting effective OSH programs; (4) the components of effective
OSH programs, including worker participation programs, training or
other organizational and administrative aspects, as well as engineering
solutions; and (5) 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.
Applications are encouraged that will evaluate interventions in
real work settings, assessment of cost-effectiveness and identification
of adverse or unexpected outcomes of interventions.
Reporting Requirements
Progress reports are required annually as part of the continuation
application (75 days prior to the start of the next budget period). The
annual progress reports must contain information on accomplishments
during the previous budget period and plans for each remaining year of
the project. Depending upon funding entity, financial status reports
(FSR) are required no later than 90 days after the end of the budget
period.
The final performance and financial status reports are required 90
days after the end of the project period. The final performance report
should include, at a minimum, a statement of original objectives, a
summary of research methodology, a summary of positive and negative
findings, and a list of publications resulting from the project.
Research papers, project reports, or theses are acceptable items to
include in the final report. The final report should stand alone rather
than citing the original application. Three copies of reprints of
publications prepared under the grant should accompany the report.
Evaluation Criteria
Upon receipt, applications will be reviewed by CDC and NIH for
completeness and responsiveness and will be assigned to the appropriate
Institute. Applications determined to be incomplete or unresponsive to
this announcement 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 announcement
will be reviewed by an initial review group and determined to be
competitive or non-competitive, based on the review criteria relative
to other applications received. Applications determined to be non-
competitive will be withdrawn from further consideration and the
principal investigator/program director and the official signing for
the applicant organization will be promptly notified. Applications
judged to be competitive will be discussed and assigned a priority
score. Following initial review
[[Page 13056]]
for scientific merit, the 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 for scientific merit are as follows:
1. Technical significance and originality of proposed project.
2. Appropriateness and adequacy of the study design and methodology
proposed to carry out the project.
3. Qualifications and research experience of the principal
investigator and staff, particularly but not exclusively in the area of
the proposed project.
4. Availability of resources necessary to perform the project.
5. Documentation of cooperation from collaborators in the project,
where applicable.
6. Adequacy of plans to include both sexes and minorities and their
subgroups as appropriate for the scientific goals of the project.
(Plans for the recruitment and retention of subjects will also be
evaluated.)
7. Appropriateness of budget and period of support.
8. Human Subjects. Procedures adequate for the protection of human
subjects must be documented. Recommendations on the adequacy of
protections include: (1) Protections appear adequate and there are no
comments to make or concerns to raise, (2) protections appear adequate,
but there are comments regarding the protocol, (3) protections appear
inadequate and the Initial Review Group has concerns related to human
subjects, or (4) disapproval of the application is recommended because
the research risks are sufficiently serious and protection against the
risks are inadequate as to make the entire application unacceptable.
Review criteria for programmatic importance are as follows:
1. Magnitude of the problem in terms of numbers of workers
affected.
2. Severity of the injury or disease in the population.
3. Usefulness to applied technical knowledge in the identification,
evaluation, or control of occupational safety and health hazards on a
national or regional basis.
4. Propensity to improve understanding of the pathophysiology
(includes biomechanics), diagnosis, treatment, and prevention of
occupational irritant dermatitis, work-related musculoskeletal
disorders and asthma or COPD caused by occupational exposures.
The following will be considered in making funding decisions:
1. Merit of the proposed project as determined by the initial peer
review.
2. Programmatic importance of the project as determined by
secondary review.
3. Availability of funds.
4. Program balance among priority areas of this announcement.
Executive Order 12372 Review
Applications are not subject to the review requirements of
Executive Order 12372.
Public Health System Reporting Requirement
This program is not subject to the Public Health System Reporting
Requirements.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance numbers are:
93.262 for the National Institute for Occupational Safety and Health
(NIOSH) in CDC
93.846 for the National Institute of Arthritis and Musculoskeletal and
Skin Diseases (NIAMS) in NIH
93.113 and 93.115 for the National Institute of Environmental Health
Sciences (NIEHS) in NIH
93.837, 93.838, and 93.839 for the National Heart, Lung, and Blood
Institute (NHLBI) in NIH
93.866 for the National Institute on Aging (NIA) in NIH
Other Requirements
Human Subjects
If the proposed project involves research on human subjects, the
applicant must comply with the Department of Health and Human Services
Regulations, 45 CFR Part 46, regarding the protection of human
subjects. Assurances must be provided to demonstrate that the project
will be subject to initial and continuing review by an appropriate
institutional review committee. The applicant will be responsible for
providing assurance in accordance with the appropriate guidelines and
form provided in the application kit.
Women and Racial and Ethnic Minorities
It is the policy of the CDC and the NIH to ensure that women and
racial and ethnic groups will be included in CDC- or NIH-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, Native Hawaiian or Other Pacific Islander,
and Hispanic or Latino. Applicants shall ensure that women and racial
and ethnic minority populations are appropriately represented in
applications for research involving human subjects. Where clear and
compelling rationale exist that inclusion is not feasible, this
situation must be explained as part of the application. In conducting
the review of applications for scientific merit, review groups will
evaluate proposed plans for inclusion of minorities and both sexes as
part of the scientific assessment and assigned score. 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, Friday, September 15, 1995, pages 47947-
47951 and/or in the ``NIH Guidelines for Inclusion of Women and
Minorities as Subjects in Clinical Research'' Federal Resister of March
28, 1994 [FR 59, 14508-14513], and reprinted in the NIH Guide for
Grants and Contracts, Vol. 23, No. 11, March 18, 1994.
Application Submission and Deadlines
A. Preapplication Letter of Intent
Although not a prerequisite of application, a non-binding letter of
intent-to-apply is requested from potential applicants. The letter
should be submitted to the Grants Management Officer (whose address is
reflected in section B, ``Applications''). It should be postmarked no
later than May 1, 1998. The letter should identify the announcement
number, name of principal investigator, and specify the priority area
to be addressed by the proposed project. The letter of intent does not
influence review or funding decisions, but it will enable CDC and NIH
to plan the review more efficiently, and will ensure that each
applicant receives timely and relevant information prior to application
submission.
B. Applications
Applicants should use Form PHS-398 (OMB Number 0925-0001) and
adhere to the ERRATA Instruction Sheet for Form PHS-398 contained in
the Grant Application Kit. Please submit an original and five copies on
or before June 23, 1998 to: Ron Van Duyne, Grants Management Officer,
ATTN: Joanne Wojcik, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry
[[Page 13057]]
Road, NE., Room 300, MS E-13, Atlanta, GA 30305.
C. Deadlines
1. Applications shall be considered as meeting a deadline if they
are either:
a. Received at the above address on or before the deadline date, or
b. Sent on or before the deadline date to the above address, and
received in time for the review process.
Applicants should request a legibly dated U.S. Postal Service
postmark or obtain a legibly dated receipt from a commercial carrier or
the U.S. Postal Service. Private metered postmarks shall not be
accepted as proof of timely mailings.
2. Applications which do not meet the criteria above are considered
late applications and will be returned to the applicant.
Where To Obtain Additional Information
To receive additional written information call 1-888-GRANTS4. You
will be asked your name and address and will need to refer to
Announcement 98044. You will receive a complete program description,
information on application procedures, and application forms. Also,
this and other CDC Announcements can be found on the CDC homepage
(http://www.cdc.gov) under the ``Funding'' section, as well as on the
NIOSH homepage (http://www.cdc.gov/niosh/homepage.html) under
``Extramural Programs.'' For your convenience, you may be able to
retrieve a copy of the PHS Form 398 from (http://www.nih.gov/grants/
funding/phs398/phs398.html).
If you have questions after reviewing the contents of all the
documents, business management information may be obtained from Joanne
Wojcik, Grants Management Specialist, Grants Management Branch,
Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East Paces Ferry Road, NE., MS E-13, Atlanta, GA
30305, telephone (404) 842-6535; fax (404) 842-6513; internet
jcw6@cdc.gov.
Programmatic technical assistance may be obtained from:
Roy M. Fleming, Sc.D., Research Grants Program, National Institute for
Occupational Safety and Health, Centers for Disease Control and
Prevention (CDC), 1600 Clifton Road, NE., Building 1, Room 3053, MS-
D30, Atlanta, GA 30333, telephone 404-639-3343; fax 404-639-4616,
internet rmf2@cdc.gov
Sidney M. Stahl, Ph.D., Behavioral and Social Research Program,
National Institute on Aging, National Institutes of Health (NIH),
Gateway Building #533, 7201 Wisconsin Avenue, Bethesda, MD 20892,
telephone 301-402-4156, fax 301-402-0051, internet ss333h@nih.gov
Alan Moshell, M.D., Skin Diseases Branch, National Institute of
Arthritis and Musculoskeletal and Skin Diseases, National Institutes of
Health (NIH), Natcher Building, Room 5AS-25L, Bethesda, MD 20892-6500,
telephone 301-594-5017, fax 301-480-4543, internet am40j@nih.gov
James S. Panagis, M.D., M.P.H., Musculoskeletal Diseases Branch,
National Institute of Arthritis and Musculoskeletal and Skin Diseases,
National Institutes of Health (NIH), 45 Center Drive, Room 5AS-37K, MSC
4500, Bethesda, MD 20892-6500, telephone 301-594-5055, fax 301-480-
4543, internet jp149d@nih.gov
George S. Malindzak, Ph.D., Division of Extramural Research and
Training, National Institute of Environmental Health Sciences, National
Institutes of Health (NIH), 79 T.W. Alexander Drive, MD EC-23, Research
Triangle Park, NC 27709, telephone 919-541-3289, fax 919-541-5064,
internet malindzak@niehs.nih.gov
Gail Weinmann, M.D., Division of Lung Diseases, National Heart, Lung,
and Blood Institute, National Institutes of Health (NIH), Two Rockledge
Center, Suite 10018, 6701 Rockledge Drive, MSC 7952, Bethesda, MD
20892, telephone 301-594-0202, fax 301-480-3557, internet
weinmanng@gwgate.nhlbi.nih.gov
Please Refer to Announcement Number 98044 When Requesting
Information and Submitting an Application.
CDC will not send application kits by facsimile or express mail.
Potential applicants may obtain a copy of ``Healthy People 2000''
(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000''
(Summary Report, Stock No. 017-001-00473-1) through the Superintendent
of Documents, Government Printing Office, Washington, DC 20402-9325,
telephone (202) 512-1800.
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''.
Linda Rosenstock,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention (CDC).
Anthony L. Itteilag,
Deputy Director for Management, National Institutes of Health.
[FR Doc. 98-6869 Filed 3-16-98; 8:45 am]
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