[Federal Register Volume 61, Number 92 (Friday, May 10, 1996)]
[Notices]
[Pages 21470-21473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11670]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 617]


National Institute for Occupational Safety and Health; 
Occupational Radiation and Energy-Related Health Research Grants; 
Notice of Availability of Funds for Fiscal Year 1996

Introduction

    The Centers for Disease Control and Prevention (CDC), National 
Institute for Occupational Safety and Health (NIOSH), announces that 
applications are being accepted for research projects relating to 
occupational safety and health concerns associated with occupational 
exposures to radiation and other hazardous agents at nuclear facilities 
and in other energy-related industries. Studies in the nuclear power 
industry and deliberate exposure of human subjects in radiation 
experiments are outside the scope of this announcement.
    CDC is 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 area of Occupational Safety and 
Health. (For ordering a copy of ``Healthy People 2000,'' see the 
section ``Where to Obtain Additional Information.'')

Authority

    This program is authorized under the Public Health Service Act, as 
amended, Section 301(a) (42 U.S.C. 241(a)); the Occupational Safety and 
Health Act of 1970, Section 20 (a) (29 U.S.C. 669(a)). The applicable 
program regulations include 42 CFR Parts 52 and 74.

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.

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and promote the nonuse 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.

Availability of Funds

    Approximately $500,000 is available in fiscal year (FY) 1996 to 
fund approximately 3 to 5 research project grants. The amount of 
funding available may vary and is subject to change. Awards will range 
from $25,000 to $200,000 in total costs (direct and indirect) per year. 
Awards are expected to begin on or about September 1, 1996. Awards will 
be made for a 12-month budget period within a project period not to 
exceed 3 years. Continuation awards within the project period will be 
made on the basis of satisfactory progress and availability of funds.

Purpose

    NIOSH will support hypothesis-testing research projects to identify 
and

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investigate the relationships between health outcomes and occupational 
exposure to radiation and other hazardous agents, epidemiologic methods 
research relevant to energy-related occupational health research, and 
research related to assessing occupational exposures.

Programmatic Interest

    The focus of grants should emphasize field research in the 
following topical areas: (1) Retrospective exposure assessment, (2) 
radiation measurement issues, (3) non-cancer morbidity and mortality 
outcomes, (4) meta-analysis and combined analysis methodologies, (5) 
uncertainty analysis, and (6) studies of current workers.

(1) Retrospective Exposure Assessment

    Epidemiologic studies of occupational cohorts frequently involve, 
and can generally benefit from, retrospective exposure assessment to 
provide estimates of exposure or categorize groups of workers by common 
exposure. Exposure assessment in energy-related occupational 
epidemiology requires evaluating exposures to various hazards including 
ionizing and non-ionizing radiation, metals, acids, and solvents. Grant 
opportunities encompass the fields of industrial hygiene and 
retrospective exposure assessment of health physics dosimetry. Research 
areas of general interest include investigations of: Methods to use 
limited data to best advantage, how to treat censored data in 
retrospective exposure assessment, uncertainty analysis techniques for 
industrial hygiene exposure data and health physics dosimetry, sampling 
strategy design to yield a representative understanding of exposed 
groups, decision logic to select and use the most appropriate exposure 
metric for epidemiologic and risk assessment use, and, development 
approaches of ``Homogeneous Exposed Groupings'' and the advantages and 
limitations for epidemiologic use. Research opportunities of specific 
interest include: reconstruction and dose adjustment of historic film 
badges; exposure assessment for acid mists, carcinogenic solvents, 
exotic metals, and leukemogens; assessment of electromagnetic field 
exposure; and evaluation of biomarkers of exposure.

(2) Radiation Measurement Issues

    This topic will focus on the applicability and utility of both 
internal and external radiation dose data in epidemiologic research. 
Examples of such issues include how to use nondetectable values, 
missing dose data in historical radiation exposure measurements, and 
the accuracy of historical external dosimetry techniques (film and 
pocket dosimeters). Additional issues of interest include the use, 
utility and limitations of internal dosimetry data (historical bioassay 
and radiochemistry techniques) in epidemiologic studies.

(3) Non-Cancer Morbidity and Mortality Outcomes

    The majority of analytical epidemiologic research of health effects 
of energy-related occupational and environmental exposures has focused 
historically on the assessment of the association between cancer 
mortality and exposure to ionizing radiation. Although the importance 
of this research should not be underestimated, it is essential that 
other potential adverse health effects, as well as other possible 
energy-related exposures, be thoroughly evaluated as well. Among these 
are the possible effects of radiation on the reproductive, neurologic, 
and immune systems. Chemical exposures highly prevalent in Department 
of Energy facilities, such as exposures to beryllium and mercury, have 
also been associated with a variety of disease outcomes, particularly 
respiratory and neurologic in nature.

(4) Meta-Analysis and Combined Analysis Methodologies

    Many of the cohorts at nuclear facilities are not individually 
large enough to detect statistically significant increases in mortality 
or incidence for rare cancer types. Methods and analyses for combining 
data across studies, whether in summary form or as individual data, are 
valuable to the NIOSH research effort involving energy-related health 
research.

(5) Uncertainty Analysis

    Measures of occupational exposure are inherently uncertain. Even 
when measures of external radiation exposure are generally available, 
the models used to estimate organ dose, shallow versus deep dose, 
neutron dose, etc., are subject to error. Measures of dose derived from 
biological monitoring of urine, feces, blood, etc., are even less 
precise. Methods for assessing the degree of error in various estimates 
of exposure to both ionizing radiation as well as other toxic agents 
(chemicals, EMF, etc.) are desirable.

(6) Studies of Current Workers

    Much of the epidemiologic research on nuclear workers conducted at 
nuclear facilities and other sites has emphasized retrospective 
studies. More recently new activities involve environmental 
restoration, waste management and other work that is not related to the 
design and production of nuclear weapons. Workers are being exposed to 
radiation and other hazardous agents under conditions and in processes 
not previously encountered. Hypothesis-testing research in the areas of 
exposure assessment, epidemiologic and related studies are needed to 
evaluate these new conditions and processes and the impact on worker 
health.

Women and Minority Inclusion Policy

    It is the policy of the CDC to ensure that women and racial and 
ethnic groups will be included in CDC supported research projects 
involving human subjects, whenever feasible and appropriate. Racial and 
ethnic groups are those defined in OMB Directive No. 15 and include 
American Indian, Alaskan Native, Asian, Pacific Islander, Black and 
Hispanic. 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.

Evaluation Criteria

    Upon receipt, applications will be reviewed by CDC for completeness 
and responsiveness. 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 evaluated for scientific and technical merit by an appropriate 
peer review group convened by CDC in accordance with the review 
criteria stated below. As part of the initial merit review, a process 
may be used by the initial review group

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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 this announcement. 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 and the principal investigator/program 
director and the official signing for the applicant organization will 
be promptly notified.
    Review criteria for this announcement are as follows:

--Scientific, technical, or medical significance and originality of 
proposed research;
--Appropriateness and adequacy of the experimental approach and 
methodology proposed to carry out the research;
--Qualifications and research experience of the Principal Investigator 
and staff, particularly but not exclusively in the area of the proposed 
research;
--Availability of resources necessary to perform the research;
--Adequacy of plans to include both sexes 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 review group will critically examine the submitted budget and 
will recommend an appropriate budget and period of support for each 
scored application.
    In the secondary (programmatic importance) review, the following 
factors will be considered:
    1. Results of the initial review;
    2. Magnitude of the problem in terms of numbers of workers 
affected;
    3. Severity of the disease or injury in the worker population; and
    4. Usefulness to applied technical knowledge in the identification, 
evaluation, and/or control of occupational safety and health hazards.
    Applicants will compete for available funds with all other approved 
applications. The following will be considered in making funding 
decisions:
    1. Quality of the proposed project as determined by peer review;
    2. Availability of funds; and
    3. Program balance among research areas of the announcement.

Executive Order 12372 Review

    Applications are not subject to the review requirements of 
Executive Order 12372, entitled Intergovernmental Review of Federal 
Programs.

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 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.

Confidentiality Agreement

    To comply with the routine uses allowing access to Department of 
Energy (DOE) Privacy Act systems of records, grantees who will be 
accessing DOE records to conduct epidemiologic studies and/or other 
public health activities on behalf of NIOSH will be asked to sign a 
written statement that documents data security procedures to be 
maintained by the grantee and an agreement to comply with the privacy 
and confidentiality requirements of the Privacy Act routine uses and 
the Memorandum of Understanding between the Department of Energy and 
the Department of Health and Human Services.

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 June 10, 1996. 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 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 July 10, 1996 to: Ron Van Duyne, 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, MS-E13, 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 (404) 332-4561. You 
will be asked your name, address, and phone number and will need to 
refer to Announcement 617. In addition, this announcement is also 
available through the CDC Home Page on the Internet. The address for 
the CDC Home Page is http://www.cdc.gov. 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 Jang, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., MS-E13, 
Atlanta, GA 30305, telephone (404) 842-6796; fax: 404-842-6513; 
internet: [email protected]. 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,

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NE., Building 1, Room 3053, MS-D30, Atlanta, GA 30333, telephone: 404-
639-3343; fax: 404-639-4616; internet: [email protected].

Please Refer to Announcement Number 617 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 2, 1996.
Donald L. Holderman,
Acting Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention (CDC).
[FR Doc. 96-11670 Filed 5-9-96; 8:45 am]
BILLING CODE 4163-19-P