Full Text ES-96-007
 
BIOLOGICAL EFFECTS OF POWER FREQUENCY EMF
 
NIH GUIDE, Volume 25, Number 18, June 7, 1996
 
RFA:  ES-96-007
 
P.T. 34

Keywords: 
  Health, Radiation Effects 
  Environmental Effects 

 
National Institute of Environmental Health Sciences
 
Letter of Intent Receipt Date:  August 2, 1996
Application Receipt Date:  August 27, 1996
 
PURPOSE
 
The National Institute of Environmental Health Sciences (NIEHS)
supports research to identify the role of environmental agents in
perturbations of normal physiologic processes leading to human
disease.  In addition, the Energy Policy Act which was signed into
law in October, 1992, authorized an accelerated  five year Electric
and Magnetic Fields (EMF) Research and Public Information
Dissemination (RAPID) Program to be administered by the Department of
Energy.  In this Act, NIEHS is designated as the lead agency for
coordinating and conducting the health effects studies and
communicating the results to policy makers and the general public on
the possible adverse effects, if any, of EMF associated with the
generation, transport and use of electricity.  Thus, as part of the
health mission of the NIEHS, studies of the biological effects of EMF
have been specifically targeted.
 
To accomplish the goals established in the 1992 Act, the NIEHS
initiated a research program consisting of grants, contracts and
cooperative agreements in 1994.  In addition, recently reported
preliminary studies suggest new directions for EMF research which may
further contribute to the assessment of a possible EMF hazard.  In
order to explore fully these observations and to further strengthen
the hazard assessment models, the NIEHS is announcing this small
grant program.  Research is specifically encouraged to identify
possible causal connections between EMF exposure and biological
effects that could be used in a hazard assessment model.  Studies
which provide data needed for the assessment of the potential
carcinogenic, reproductive or neurologic effects of EMF exposure are
considered a priority.  However, other toxic effects also may be
important to consider.  The goal of this Small Grants Program (R03),
Request for Applications (RFA) is to support studies that provide
data needed for the hazard assessment of EMF.
 
HEALTHY PEOPLE 2000
 
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 for setting priority areas.  This RFA,
Biological Effects of Power Frequency EMF, is related to the priority
area of environmental health.  Potential applicants may obtain a copy
of "Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or
Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington
DC 20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic and foreign for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of state and local
governments, and eligible agencies in the Federal government.
Simultaneous submissions of both a small grant and a regular research
grant (R01) application on the same topic will not be accepted.
Racial/ethnic minority individuals, women and persons with
disabilities are encouraged to apply.
 
MECHANISM OF SUPPORT
 
This RFA will use the NIH small grant (R03) mechanism.
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  The requested
costs and project period will be $50,000 (direct cost) per year for a
maximum of two years and a maximum of $100,000 direct costs.  Small
grants are not renewable, but may be extended at no additional costs
at the discretion of the applicant organization.
 
FUNDS AVAILABLE
 
The total estimated funds available for this small grants program is
$2.25 million, which will support approximately 15 to 30 awards.
This level of support is dependent on the receipt of a sufficient
number of applications of high scientific merit.  Although this
program is provided for within the financial plans of the NIEHS,
awards pursuant to this RFA are contingent upon the transfer of funds
for this purpose from the Department of Energy.
 
RESEARCH OBJECTIVES
 
Background
 
As a result of electrification of our homes and work places, people
from all walks of life and of all ages are now exposed to power
frequency (60 Hz) electric and magnetic fields.  Increasingly,
scientists, regulators and the public are asking whether or not
exposure to these fields could involve risks to human health.  Such
questions are based in part on the results of epidemiology studies
that indicate that exposure to power line frequency electric and
magnetic fields (EMF) may increase risk for certain forms of cancer.
In addition, studies have shown that certain types of EMF exposure
can cause small variations in heart rate and reaction times in
humans.  There have also been some reports of individuals with
unusual sensitivity when exposed to fields.  Numerous experiments
suggest alterations in cellular processes or in endocrine functions
of whole animals.  However, the biological significance of these
studies is uncertain, and it is unclear whether these effects are
predictors of adverse health effects in humans.  Thus, additional
research on the biological effects of EMF exposure at 60 Hz is
needed.
 
The goal of the EMF Research and Public Information Dissemination
(RAPID) Program is the improvement of our understanding of the
potential contribution, if any, of field exposure to the development
of disease.  To achieve this goal, it is imperative to have
information on the effects of EMF on a wide variety of biological
functions related to carcinogenic, reproductive, neurological or
other health effects.  Data are needed to foster the development of a
mechanistically-based understanding of the relationship between EMF
exposure and alteration in biological processes that could lead to
human disease or dysfunction.  This RFA is intended to support
studies that provide further data needed for the hazard assessments
of EMF exposure. It is anticipated that these studies will contribute
to the data base necessary to establish the cause and effect
relationship between EMF and changes in biological functions which
could ultimately contribute to a disease or provide data that an
effect does not exist.
 
Research Goals
 
The focus of this RFA is the further development of data that could
be used to assess the carcinogenic, reproductive, neurological, and
other biological hazards of EMF.  Thus, it is important that
applications address possible gaps in data needed for hazard
assessment complementing previously described biological effects of
EMF.  Studies that reduce the uncertainties about reported biological
effects of EMF will also be considered.  It is important that
applicants describe how any biological finding can be directly
related to human health risks.  Research approaches that may identify
novel biological effects should also assess the biological
significance of such effects.  However, projects that help reduce the
uncertainty about human health hazards associated with exposure to
EMF are a high priority.  Applications that are simply a variation of
current research will not be considered responsive to this RFA.
 
The following list provides examples of current research interest,
but it is not intended to be complete.  Applications for work that is
based upon analysis of extant data without further experimentation
will be considered.  Investigators are encouraged to study these or
other topics.
 
o  Effects on cell signaling and membrane processes such as protein
kinases, calcium flux, or gap junctions,
 
o  Effects on DNA stability, damage, adducts or demethylation, etc.
 
o  Quantification of exposure-related effects on cell cycle,
differentiation and cell death;
 
o  Development of mechanistic models (quantitative or qualitative)
which link cellular responses with morbidity and/or mortality in vivo
for previously described health effects of EMF;
 
o  Effects of EMF exposure on the response of biological systems to
polychlorinated or other environmentally persistent compounds;
 
o  Development of risk assessment models for cancer, reproductive,
neurologic or other potential EMF risks;
 
o  Studies of the potential biological effects for exposure
conditions such as harmonics, transients or intermittency;
 
o  Evaluation of dose/effect relationships for EMF biological
effects;
 
o  Postnatal consequences of EMF exposure in utero;
 
o  Effects on Oncogenes.
 
EMF Exposure Conditions
 
Funds provided in this RFA are not sufficient to purchase EMF
exposure systems for the studies to be proposed.  For investigators
who do not already have carefully characterized exposure systems,
NIEHS encourages arrangements for the use of existing EMF facilities
maintained by NIEHS or DOE researchers.  Regional EMF exposure
facilities supported by DOE and NIEHS may also be available for use
under cooperative agreements.  Availability of appropriate facilities
must be documented in the grant application.
 
To assist applicants in the preparation of an application,
information on the EMF research projects currently funded by NIEHS
and DOE, the regional exposure facility sites, and the physical
considerations for an EMF exposure system can be obtained from the
NIEHS.  Requests should be addressed to Dr. Michael Galvin at the
address listed under INQUIRIES.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by August 2, 1996, a
letter of intent that includes a descriptive title of the proposed
project, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA (BIOLOGICAL EFFECTS
OF POWER FREQUENCY EMF).
 
Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of
applications.  It allows NIEHS staff to estimate the potential review
workload and to avoid conflict of interest in the review.
 
The letter of intent is to be sent by August 2, 1996 to:
 
Dr. Michael J. Galvin, Jr.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
104 T.W. Alexander Drive
P.O. Box 12233
Research Triangle Park, NC  27709
Telephone:  (919) 541-7825
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Office of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/435-0714, email:
ASKNIH@odrockm1.od.nih.gov.
 
The following supplemental instructions are provided:
 
Only one small grant application may be submitted by a principal
investigator.
 
The Detailed Budget for the Initial Budget Period (Form Page 4-DD)
and Budget for Entire Proposed Period of Support (Form Page 5 EE.)
should be completed as instructed on Page 11 of the PHS 398.  The
project period for these awards is a maximum of two years.  The
maximum amount awarded to each grantee on this RFA will be $100,000
direct costs for a two year project period.  The amount awarded for
any given year (budget period) will not exceed $50,000 direct costs.
Equipment will be limited to $10,000 direct costs for the project.
Indirect costs will be awarded at the grantee's current negotiated
indirect cost rate at the time of the award.
 
Travel for the principal investigator to an EMF grantee meeting
should be included in the budget.
 
The Research Plan (Specific Aims, Background and Significance,
Preliminary Studies, Research Design and Methods sections) is not to
exceed Ten (10) pages.  Tables and figures are included in the Ten
(10) page limitation.  Applications that exceed page limitations or
PHS 398 requirements for font size (height or letters), type density
(characters per inch), and margins (see PHS 398 directions) will be
returned to the investigator.
 
Do not submit an appendix.
 
Applications must be received by August 27,1996.  If an application
is received after that date, it will be returned to the applicant
without review.  The RFA label available in the PHS 398 (rev. 5/95)
application form must be affixed to the bottom of the face page of
the application.  Failure to use this label could result in delayed
processing of the application such that it may not reach the review
committee in time for review.  In addition, the RFA title and number
must be typed on line 2 of the face page of the application form and
the YES box must be marked.
 
Submit a signed, typewritten original of the application, including
the checklist, and three signed, clear, and single sided photocopies
in one package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application
must be sent to:
 
Ethel Jackson, D.D.S.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD 17-09
104 T.W. Alexander Drive, Building 17, Room 1717
Research Triangle Park, NC  27709
Telephone:  (919) 541-7846
FAX:  (919) 541-2503
Email:  jackson4@niehs.nih.gov
 
If these two additional copies are not forwarded to Dr. Jackson, it
will adversely affect the review of the grant application
 
REVIEW CONSIDERATIONS
 
Upon receipt, all applications will be reviewed by the Division of
Research Grants (DRG) for completeness and
by the NIEHS for responsiveness to the RFA.  Incomplete and/or
nonresponsive applications will be returned to the applicant without
further consideration.  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 NIEHS in accordance
with the standard NIH peer review procedures.  As part of the initial
merit review, all applications will receive a written critique and
undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications
under review, will be discussed, assigned a priority score, and
receive a second level review by the national advisory council or
board.
 
Review criteria for this RFA are the same as those for unsolicited
research grant applications.
 
o  Availability of resources necessary to perform project objectives.
 
o  Appropriateness of the proposed budget and duration in relation to
proposed objectives.
 
o  Strength of institutional commitment as evidenced by provision of
appropriate resources, services, technical support, and allocation of
space.
 
o  The approach of the investigator to assess not only the biological
effects of the 60 Hz fields but also the significance, if any, to
human health risk.
 
o  Experimental approaches to determining the biological significance
of any findings.
 
AWARD CRITERIA
 
The anticipated date of award is February 1, 1997.  The following
will be considered in making funding decisions:
 
o  Relevance to the hazard (toxicity) assessment of EMF,
o  quality of the proposed project as determined by peer review,
o  availability of funds,
o  program balance and relevance to mission of NIEHS.
 
Applicatons that address aspects of EMF directly related to the
hazard assessment of previously identified health effect such as
carcinogenesis, reproductive toxicity or neurological effects will be
assigned a higher award priority.
 
INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Michael J. Galvin, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD 3-02
104 T.W. Alexander Drive, Building 3, Room 316
Research Triangle Park, NC  27709
Telephone:  (919) 541-7825
FAX:  (919) 541-2843
Email:  Galvin@niehs.nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Mr. David L. Mineo
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD 2-01
104 T.W. Alexander Drive, Building 2, Room 203B
Research Triangle Park, NC  27709
Telephone:  (919) 541-7628
FAX: (919) 541-2860
Email:  mineo@niehs.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.113 and 93.115. Awards are made under authorization
of the Public Health Service Act, Title IV, Part A (Public Law
78-410, as amended by Public Law 99-158, 43 USC 241 and 285) and
administered under PHS grants policies and Federal Regulations 42 CFR
52 and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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