Implementation of the National Occupational Research Agenda; Notice of Availability of Funds for Fiscal Year 1998

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

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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

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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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