[Federal Register Volume 60, Number 87 (Friday, May 5, 1995)]
[Notices]
[Pages 22397-22400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11139]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement 534]


National Institute for Occupational Safety and Health; Worker 
Exposure Assessment and Hazard and Medical Surveillance Programs; 
Notice of Availability of Funds for Fiscal Year 1995

Introduction

    The Centers for Disease Control and Prevention (CDC), National 
Institute for Occupational Safety and Health (NIOSH) announces the 
availability of fiscal year (FY) 1995 funds for a grant program for 
worker hazard and medical surveillance projects associated with 
occupational exposures to radiation and other hazardous agents at 
nuclear facilities and other energy-related industries. Studies 
conducted in the nuclear power industry and deliberate exposure of 
human subjects in radiation experiments are outside the scope of this 
announcement.
    The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of ``Healthy People 
2000,'' a PHS-led national activity to reduce morbidity and mortality 
and improve the quality of life. This announcement is related to the 
priority area of Occupational Safety and Health. (For ordering a copy 
of ``Healthy People 2000,'' see section ``Where to Obtain Additional 
Information.'')

Authority

    This program is authorized under the Occupational Safety and Health 
Act of 1970, Section 20(a) and 22(e)(7), [29 U.S.C. 669(a) and 
671(e)(7)]. The applicable grant program regulations are in 42 CFR Part 
52.

Smoke-Free Workplace

    PHS strongly encourages all grant recipients to provide a smoke-
free workplace and to 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, [[Page 22398]] and early childhood 
development services are provided to children.

Eligible Applicants

    Eligible applicants include domestic non-profit and for-profit 
organizations, universities, colleges, research institutions, national 
laboratories, other public and private organizations, including State 
and local governments, labor unions and other employee representative 
groups, and small, minority and/or women-owned businesses.

Availability of Funds

    Approximately $1.5 million is available in FY 1995 to fund 
approximately 4 to 6 research project grants (R01). It is expected that 
the average award will be $300,000, ranging from $200,000 to $400,000 
in total costs (direct and indirect costs) per year. It is expected 
that the awards will begin on or about September 1, 1995, and will be 
made for a 12-month budget period within a project period of up to 3 
years.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and availability of funds.

Purpose

    The efforts funded by these grants will help in the development of 
model exposure assessment and hazard and medical surveillance programs 
applicable to both the defense nuclear industry and general 
occupational settings. NIOSH will support applied field research 
projects to develop surveillance methodologies and to assess the 
functional, real-world outcomes of model program(s). Therefore, to 
assess what components might be needed for a comprehensive model 
surveillance program (applicable to defense nuclear sites and to 
occupational settings in general), grantees may review and compare 
activities at existing pilot surveillance program sites.

Program Interests

1. Job Task Analysis/Exposure Assessment and Hazard Surveillance

    Workers should be classified according to risk in medical and 
epidemiological surveillance programs. An understanding of prospective 
and retrospective exposures is required to properly classify workers 
into risk groups. Frequently, the absence of exposure monitoring data 
on individual workers results in a reliance on surrogate measures of 
exposure, such as job titles, to estimate risks for groups of workers. 
Even where exposure monitoring data may be abundant, its interpretation 
may result in poor estimates of worker risk if the purpose for 
collecting the data is vague or unknown. Analyses of job titles, 
building occupancy, and operational procedures and practices have been 
linked with exposure monitoring data to improve classification methods. 
The ideal approach for exposure monitoring and other subjective 
assessment techniques, in support of medical and epidemiologic 
surveillance programs, has been shown to require accurate 
characterization of exposures associated with specific job tasks which 
may then be weighted appropriately for individual workers performing 
different series of tasks. The outcome from such a strategy is that 
more valid estimates of exposure are available on groups of workers, 
resulting in more reliable estimates of risk. However, the 
disadvantages of such an approach are that it is resource intensive and 
limited primarily to prospective studies. Therefore, there is a need 
for research to improve and further develop feasible strategies to 
assess and record occupational exposures to potentially harmful 
hazards.
    a. Worker self-monitoring. Proposals are solicited to look at 
existing programs, evaluate these existing programs and develop new 
methods (as appropriate) that could be used to demonstrate reliable 
worker self-monitoring and subjective exposure assessment techniques. A 
proposal that identifies the sources of errors when workers self 
monitor and suggests methods that would minimize those errors would be 
responsive to this request. The success of ``self-monitoring'' should 
be analyzed in contrast to classical industrial hygiene/health physics 
directed monitoring.
    b. Biological exposure indicators. In many situations biological 
exposure indicators are useful measures of an individual's exposure. 
Proposals are solicited to look at existing programs, to evaluate these 
existing programs and to develop new non-invasive biological exposure 
indicators (Reference--1994-1995 Threshold Limit Values and Biological 
Exposure Indices, American Conference of Governmental Industrial 
Hygienists, 1994.)
    c. Exposure histories. Exposure history questionnaires depend on 
the individual's ability to remember details of tasks performed and 
materials used in past work assignments. More accurate information 
might be possible if the questionnaires could be better linked to data 
about hazards and hazardous material and agents used in the facilities. 
Proposals are solicited to look at existing programs, to evaluate these 
existing programs and to develop, as appropriate, methods that would 
aid an individual in more accurately reconstructing exposures to health 
and injury hazards.
    d. Other proposals. Proposals are sought to look at existing 
programs, to evaluate these existing programs and to develop 
appropriate innovative methods to accurately group employees by 
exposure so that medical and epidemiologic surveillance programs can be 
better targeted at occupational health and injury outcomes.

2. Medical Screening

    To ensure the highest quality, state-of-the-art occupational health 
care for workers, it is essential that medical screening examinations 
be directed toward the detection and treatment of health effects and/or 
adverse health outcomes from a multitude of exposures in the workplace. 
For example, at nuclear energy facilities important work-related 
diseases and injuries include such problems as bladder cancer, 
beryllium disease, hearing loss, musculoskeletal injuries, heat stress, 
and radiation effects. Similar diseases and injuries are important to 
non-defense nuclear facilities having work activities related to 
hazardous waste operations or where similar exposures might occur.
    With this in mind, a ``convincing'' decision logic needs to be 
developed for what should trigger specific medical screening (and the 
medical surveillance program components thereof). This decision logic 
needs to be generic in nature and be developed for the types of 
potential exposures/diseases such as those of hazardous waste workers 
and workers conducting decontamination and decommissioning operations. 
Proposals should demonstrate the familiarity with medical screening, 
public health surveillance and the general principles of conducting 
such activities.
    Research also needs to be conducted for:
    (a) Assessment of existing clinical screening tests and biomarkers 
related to radiation and non-radiation exposures; and
    (b) Development of new clinical screening tests and biomarkers 
related to selected radiation and non-radiation exposures.
    Grant proposals can be submitted as a response to Items 1. and/or 
2. as presented above. Within Item 1., proposals can be submitted for 
one or more of a.-d. In addition, for each project chosen, the 
proposals should include a component on evaluating the economic 
benefits of implementing an [[Page 22399]] improved surveillance 
program in the selected surveillance area ( i.e., the cost benefits of 
reducing and/or eliminating workplace hazards versus keeping a 
situation ``status quo'').

Inclusion of Minorities and Women in Study Populations

    Applicants are required to give added attention (where feasible and 
appropriate) to the inclusion of minorities and/or women study 
populations for research into the etiology of diseases, research in 
behavioral and social sciences, clinical studies of treatment and 
treatment outcomes, research on the dynamics of health care and its 
impact on disease, and appropriate interventions for disease prevention 
and health promotion. Exceptions would be studies of diseases which 
exclusively affect males or where involvement of pregnant women may 
expose the fetus to undue risks. If minorities and/or women are not 
included in a given study, a clear rationale for their exclusion must 
be provided.

Evaluation Criteria

1. General

    Upon receipt, applications will be reviewed for completeness and 
responsiveness by NIOSH, CDC. Incomplete applications will be returned 
to the applicant without further consideration. If NIOSH, CDC staff 
find that the application is not responsive to the Request for 
Assistance (RFA), it will be returned without further consideration.
    The conduct of the research will require that the successful 
applicant develop and maintain a working relationship with the 
management and employee representatives at the site(s) selected for 
study. Letters of support and/or cooperation are needed in the grant 
application. For more information about these letters, potential 
applicants should contact the programmatic technical advisor (Dr. Roy 
Fleming) listed in the subsequent section ``Where to Obtain Additional 
Information.''

2. Peer Review

    Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NIOSH, CDC, in accordance with the review 
criteria stated below. As part of the initial peer review, a process 
(triage) may be used by the initial review group in which applications 
will be determined to be competitive or non-competitive based on their 
scientific merit relative to other applications received in response to 
the RFA. Applications judged to be competitive will be discussed and 
assigned a priority score. Applications determined to be non-
competitive will be withdrawn from further consideration; the Principal 
Investigator/Program Director and the official signing for the 
applicant organization will be promptly notified.
Review Criteria
    a. Scientific, technical, or medical significance and originality 
of proposed research;
    b. Appropriateness and adequacy of the experimental approach and 
methodology proposed to carry out the research;
    c. Qualifications and research experience of the Principal 
Investigator and staff, particularly, but not exclusively, in the area 
of the proposed research;
    d. Availability of resources necessary to perform the research; and
    e. Adequacy of plans to include both genders and minorities and 
their subgroups, as appropriate, for the scientific goals of the 
research. (Plans for the recruitment and retention of subjects will 
also be evaluated.)
    The peer review group also will critically examine the submitted 
budget and recommend an appropriate budget and period of support for 
each scored application.

3. Secondary Review

    In the secondary (programmatic importance) review, the following 
factors will be considered:
    a. Results of the initial peer review;
    b. Magnitude of the problem in terms of numbers of workers 
affected;
    c. Severity of the disease or injury in the worker population; and
    d. Usefulness to applied technical knowledge in the identification, 
evaluation, and/or control of occupational safety and health hazards.

4. Funding Decisions

    Applicants will compete for available funds with all other approved 
applications. The following will be considered in making funding 
decisions:
    a. Quality of the proposed project as determined by peer review;
    b. Availability of funds; and
    c. Program balance among research areas described in the 
announcement.

Executive Order 12372 Review

    This program is not subject to the Executive Order 12372 review.

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 number is 93.262.

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. Assurance must be provided to demonstrate that the project 
will be subject to initial and continuing review by the appropriate 
institutional review committees. The applicant will be responsible for 
providing assurance in accordance with the appropriate guidelines and 
form provided in the application kit.

Application Submission and Deadlines

1. 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 Branch, CDC (see 
``Applications'' for address). It should be postmarked no later than 
June 5, 1995. 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 NIOSH/CDC to 
plan the review more efficiently, and will ensure that each applicant 
receives timely and relevant information prior to application 
submission.

2. 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 application package. The original and five copies of the 
application must be submitted to Henry S. Cassell, III, Grants 
Management Officer, Grants Management Branch, Procurement and Grants 
Office, Centers for Disease Control and Prevention, (CDC), 255 East 
Paces Ferry Road, NE., Room 300, Mailstop E13, Atlanta, GA 30305 on or 
before July 3, 1995. [[Page 22400]] 

3. Deadline

    A. Applications shall be considered as meeting the deadline if they 
are either:
    1. Received at the above address on or before the deadline date; or
    2. Sent on or before the deadline date to the above address, and 
received in time for the review process. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier of the U.S. Postal Service. Private 
metered postmarks shall not be accepted as proof of timely mailing.)
    B. Applications which do not meet the criteria in 3.A.1. or 3.A.2. 
above are considered late applications. Late applications will not be 
considered in the current competition and will be returned to the 
applicant.

Where to Obtain Additional Information

    To receive additional written information call (404) 332-4561. You 
will be asked to leave your name, address and telephone number and will 
need to refer to Announcement 534. You will receive a complete program 
description, information on application procedures, and application 
forms.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from Georgia L. Jang, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop 
E13, Atlanta, GA 30305, telephone (404) 842-6796. Programmatic 
technical assistance may be obtained from Roy M. Fleming, Sc.D., 
Associate Director for Grants, National Institute for Occupational 
Safety and Health, Centers for Disease Control and Prevention (CDC), 
1600 Clifton Road, NE., Building 1, Room 3053, Mail Stop D-30, Atlanta, 
GA 30333, telephone (404) 639-3343.
    Please refer to Announcement 534 when requesting information and 
submitting an application.
    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.

    Dated: May 1, 1995.
Linda Rosenstock,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention (CDC).
[FR Doc. 95-11139 Filed 5-4-95; 8:45 am]
BILLING CODE 4163-19-P