[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,

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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

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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

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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 
[email protected].
    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 [email protected]
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 [email protected]
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 [email protected]
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 [email protected]
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 [email protected]
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 
[email protected]

    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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