[Federal Register Volume 62, Number 87 (Tuesday, May 6, 1997)]
[Notices]
[Pages 24657-24661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11688]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement Number 740]


Occupational Radiation and Energy-Related Health Research Grants; 
Notice of Availability of Funds for Fiscal Year 1997

Introduction

    The Centers for Disease Control and Prevention (CDC), National 
Institute for Occupational Safety and Health (NIOSH), announces that 
grant 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)) and the Occupational Safety 
and Health Act of 1970, sections 20(a) and 22 (29 U.S.C. 669(a) and 
671). The applicable program regulation is 42 CFR Part 52.

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: 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, contract, loan, or any other form.

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-use of

[[Page 24658]]

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 $250,000 is available in fiscal year (FY) 1997 to 
fund approximately 3 to 5 research project grants (R01). The amount of 
funding available may vary and is subject to change. Awards will range 
from $50,000 to $100,000 in total costs (direct and indirect) per year. 
Awards are expected to begin on or about September 1, 1997. 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.

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 1997 HHS Appropriations Act, which became 
effective October 1, 1996, expressly prohibits the use of 1997 
appropriated funds for indirect or ``grass roots'' lobbying efforts 
that are designed to support or defeat legislation pending before State 
legislatures. This new law, section 503 of Public Law 104-208, provides 
as follows:

    Sec. 503(a) No part of any appropriation contained in this Act 
shall be used, other than for normal and recognized executive-
legislative relationships, 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, * * * 
except in presentation to the Congress or any State legislative body 
itself.
    (b) 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.

    Department of Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Act, 1997, as enacted by the Omnibus 
Consolidated Appropriations Act, 1997, Division A, Title I, section 
101(e), Public Law 104-208 (September 30, 1996).

Background

    The Secretary, Department of Health and Human Services (HHS) and 
the Secretary, Department of Energy (DOE) signed a Memorandum of 
Understanding (MOU) transferring the authority and resources to manage 
and conduct energy-related analytic epidemiologic research from DOE to 
HHS. This includes the authority, resources, and responsibility for the 
design, implementation, analysis, and scientific interpretation of 
analytic epidemiologic studies of the following populations: workers at 
DOE facilities; other workers potentially exposed to radiation; and 
workers exposed to potential hazards resulting from non-nuclear energy 
production and use.
    The Comprehensive Epidemiologic Data Resource (CEDR) was 
established by DOE to serve as a repository for data from epidemiologic 
studies they had sponsored prior to transferring this responsibility to 
CDC. These data are available to investigators who wish to conduct 
additional analyses on these completed studies in response to this 
program announcement. The CEDR is maintained by DOE and to access the 
data, an investigator must make an application to the DOE's Office of 
Environment, Safety and Health.

Purpose

    NIOSH will support applied field research projects to identify and 
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 reflect the following topical areas, 
emphasizing field research: (1) Occupational exposure assessment, (2) 
radiation measurement issues, (3) non-cancer morbidity and mortality 
outcomes, (4) meta-analysis and combined analysis methodologies, (5) 
uncertainty analysis, (6) effects of measurement error on risk 
estimates, and (7) 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: 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; insight to sampling 
strategy design yielding a representative understanding of exposed 
groups; decision logic to select/use the most appropriate exposure 
metric for epidemiologic and risk assessment use; and, development 
approaches of ``Homogeneous Exposed Groupings'' and the advantages/
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 radiation 
dose data in epidemiological research. Examples of such issues include 
how to use nondetectable values and missing dose data in historical 
radiation exposure measurements, the accuracy of historical external 
dosimetry techniques (film and pocket dosimeters), combining external 
and internal doses into a useful index, historical bioassay, and 
radiochemistry techniques.

(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

[[Page 24659]]

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 would 
be the possible effects of radiation on the reproductive, neurologic, 
and immune systems. Chemical exposures highly prevalent in Department 
of Energy facilities, such as 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/or analyses for 
combining data across studies, whether in summary form or 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) Effects of Measurement Error on Risk Estimates

    Estimation of both bias and imprecision introduced into risk 
analyses through exposure measurement error have recently received 
considerable attention. Many of the suggested approaches are very 
computer intensive. Practical solutions to this problem with regard to 
the spectrum of epidemiologic designs (cohort, case-control, cross-
sectional, etc.) are needed, with particular attention to the nature of 
exposure measurement in radiation epidemiology.

(7) 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. Exposure assessment, epidemiologic and 
related studies are needed to evaluate these new conditions and 
processes and the impact on worker health.

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. 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.
    In addition, under 45 CFR 74.36(c), ``The Federal Government has 
the right to: (1) Obtain, reproduce, publish, or otherwise use the data 
first produced under an award; and (2) authorize others to receive, 
reproduce, publish, or otherwise use such data for Federal purposes.'' 
This regulation is consistent with an HHS, DOE, MOU requirement that 
any data collected on workers at DOE facilities must be sent to DOE 
with personal identifiers removed. These data are then included in the 
CEDR database for future reference by other researchers. On or before 
the expiration date of the grant, the applicant shall submit study 
data, with appropriate documentation, to the CEDR, maintained by the 
Department of Energy at the Lawrence Berkeley Laboratory. This shall 
include analysis files and separate analytic files for all relevant 
study data, including demographic variables, radiation dosimetry, 
industrial hygiene, work history, and/or medical records data. A 
written report describing each data set and a code book for each data 
set shall also be submitted. Information about preparation of CEDR 
files can be obtained from Barbara Brooks (DOE Headquarters, telephone 
301-903-4674) or Mark Durst (Lawrence Berkeley Labs, telephone 510-486-
4136).

Evaluation Criteria

    Upon receipt, applications will be reviewed by NIOSH 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 appropriate 
peer reviewers in accordance with the review criteria stated below. As 
part of the initial merit review, a process (triage) may be used by the 
peer reviewers in which applications will be determined to be 
competitive or non-competitive using the evaluation criteria below to 
determine their scientific merit relative to other applications 
received in response to this announcement. Applications judged to be 
competitive will be discussed and be 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.
    The review criteria are:

--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 peer reviewers will critically examine the submitted budget and 
will recommend an appropriate budget and period of support for each 
scored application.

[[Page 24660]]

    Secondary review criteria for programmatic importance are as 
follows:
    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.
    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 that were submitted in response to this program 
announcement. The following will be considered in making funding 
decisions:

1. Quality of the proposed project as determined by peer review.
2. Availability of funds.
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. In addition, the applicant will 
be responsible for complying with a NIOSH-DOE agreement that assures 
the research protocol is reviewed by the institutional review 
committee(s) (if such a committee exists) at each DOE site where the 
research will be conducted. This process will be coordinated by NIOSH 
after the award of the grant.

Women and Racial and Ethnic Minorities

    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.

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.

Travel

    The applicant shall include in its proposal the costs of travel to 
NIOSH in Cincinnati, Ohio, for the annual meeting of energy-related 
research extramural partners.

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 30, 1997. 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 15, 1997 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 321, 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 a complete program description, information on 
application procedures, and application forms, call (404) 332-4561. You 
will be asked your name, address, and telephone number and will need to 
refer to Announcement 740. 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. 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-E13,

[[Page 24661]]

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., 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, MS-D30, Atlanta, GA 30333, telephone (404) 639-3343, fax: 
(404) 639-4616; internet: [email protected].
    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: April 29, 1997.
Diane D. Porter,
Acting Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention (CDC).
[FR Doc. 97-11688 Filed 5-5-97; 8:45 am]
BILLING CODE 4163-19-P