Full Text CA-95-002

OCCUPATIONAL EXPOSURE AND CANCER PREVENTION/CONTROL RESEARCH

NIH GUIDE, Volume 23, Number 35, October 7, 1994

RFA:  CA-95-002

P.T. 34

Keywords: 
  Occupational Health and Safety 
  Cancer/Carcinogenesis 
  Disease Prevention+ 


National Cancer Institute
National Institute for Occupational Safety and Health

Letter of Intent Receipt Date:  January 10, 1995
Application Receipt Date:  February 17, 1995

PURPOSE

The Divisions of Cancer Etiology and Cancer Prevention and Control,
National Cancer Institute (NCI) and the National Institute for
Occupational Safety and Health (NIOSH) invite grant applications for
innovative epidemiologic studies among populations occupationally
exposed to potential carcinogenic substances.  The purpose of this
Request for Applications (RFA) is to promote cancer control research
activities.  Special emphasis is placed on investigating minority
populations and women, who have not been studied adequately in the
past, as well as small businesses, because of constraints in addressing
their occupational health problems.

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,
Occupational Exposure and Cancer Prevention/Control Research, is
related to the priority area of cancer. 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 202/783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic non-profit and for-profit
institutions, public and private, such as colleges, universities,
hospitals, research laboratories, units of State and local governments,
and eligible agencies of the Federal government.  Applications from or
involving minority institutions, individuals, and women are encouraged.

MECHANISM OF SUPPORT

This RFA will be supported through NIH research project grants (R01).
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  The total
project period for applications submitted in response to the present
RFA may not exceed four years.

This RFA is a one-time solicitation.  Competing continuation
applications will compete with all other unsolicited applications and
be reviewed by a Division of Research Grants study section.

If NCI and NIOSH determine that there is a sufficient continuing
program need, the NCI and NIOSH may announce a request for new and
renewal applications.  NIOSH has a long-standing interest in the
identification, evaluation, and control of cancers caused by
occupational exposures, and NIOSH will continue to accept
cancer-related grant proposals under its regular grants program
announcement.

FUNDS AVAILABLE

The funds for this RFA come from the NCI Cancer Control budget.
Approximately $2.0 million per year in total costs for four years will
be committed by the NCI to specifically fund applications submitted in
response to this RFA.  In addition, $300,000 per year in total costs
will be committed by the NIOSH to fund at least one application.  This
funding level is dependent on the receipt of a sufficient number of
applications of high scientific merit.  Because the nature and scope of
the research proposed in response to this RFA may vary, it is
anticipated that the size of an award will also vary.  The expected
number of awards is six to eight.  Although this program is provided
for in the financial plans of the NCI and NIOSH, the award of grants
pursuant to this RFA is contingent upon the availability of funds for
this purpose.

RESEARCH OBJECTIVES

Background

The identification of occupational exposures that carry a long-term
risk of disease or death is a major public health and scientific
concern for the general population and especially minorities.  Many
well-known human carcinogens were first identified in the occupational
environment on the basis of case reports by alert clinicians or
pathologists.  These discoveries were often serendipitous, requiring
the recognition of a cluster of unusual or rare tumors in a medical
practice that could be tied to an occupational exposure.

Exposures and technologies in the workplace, however, are changing.
Improvements in industrial hygiene and worker protection have reduced
the risks of cancer in some groups.  Nevertheless, exposures and risks
at lower levels may remain.  Many industries and occupations have
reported cancer excess for which the causative agent or agents have yet
to be identified.  Research is needed on how occupational exposures
interact with non-occupational exposures and with susceptibility
factors.  Occupational cancer among minority workers, inner city and
rural populations is an understudied aspect of occupationally related
cancer.  Moreover, it has been estimated that about 5000 new chemicals
are being introduced annually in the form of new commercial products,
chemicals, foods, and drugs, and any potential risks are likely to be
greatest and most easily detected in exposed workers.  It is therefore
necessary to continue evaluating the carcinogenic risks for various
occupational groups.

Epidemiologic studies of occupational groups are important not only to
detect carcinogenic risks, but also to verify the effectiveness of
reducing exposures, to define the agents responsible for the excess
risk in occupations exposed to complex mixtures, and to assess how
occupational agents interact with other cancer risk factors and
demographic variables such as age at first exposure.

It is important that information from occupational cancer studies be
communicated to workers and regulatory agencies.  The workers under
study must be informed and educated about the potential risks
associated with their employment and particular exposures.  Information
must also be disseminated to labor unions, industrial groups and other
concerned organizations to inform workers and take necessary
precautions.  Improved procedures are needed to identify, trace and
counsel workers who are members of specific occupational cohorts in
which risks have been discovered or quantified.

Modern molecular epidemiologic techniques my permit not only the direct
or indirect identification of exposures to chemicals, but also the
study of variations in host susceptibility that may be of genetic or
environmental origin.  Internal dose markers may provide an estimate of
the biologically effective exposure received by an individual, or
provide markers of preclinical disease response to exposure.

The major goal of identifying occupational determinants of cancer is to
introduce preventive measures.  Occupational exposure can be controlled
by the application of a number of well-known principles, including
engineering techniques (substitution, isolation, and ventilation), work
practices, and personal protective equipment.  These principles may be
applied at or near the hazard source, to the general workplace
environment, or at the point of occupational exposure to individuals.
Controls applied at the source of the hazard, including material
substitution, process or equipment modification, isolation or
automation, local ventilation, and work practices, are generally
preferred and most effective in terms of both occupational and
environmental concerns.  Controls that may be applied to hazards that
have escaped into the workplace environment include dilution
ventilation, dust suppression, and housekeeping.  Control measures may
also be applied near individual workers, including the use of
ventilated control rooms, isolation booths, supplied-air cabs, work
practices, and personal protective equipment.  The additional
strategies for cancer control include:  (l) regulation of carcinogens
and appropriate substitution of agents in the work environment, (2)
screening and early detection of occupationally-related cancer, (3)
when appropriate, evaluation of chemopreventive agents that may inhibit
the carcinogenic process, and (4) development of programs to reduce
exposures (e.g., smoking) that may interact with occupational
carcinogens to potentiate the risk of cancer.

One area where an emphasis is needed is small businesses.  The reason
is that (1) the Occupational Safety and Health Administration (OSHA) is
legislatively refrained from regularly inspecting businesses with 10 or
fewer employees, with certain exceptions, and (2) data from NIOSH's
National Occupational Exposure Survey showed that full-time health and
safety services are rarely found in facilities having fewer than 50
employees.  Thus, based on the OSHA constraints and NIOSH data,
estimates have been made that up to 90 percent of all work sites,
covering 40 percent of the total work force are not regularly inspected
and do not have ready access to health and safety expertise.  New
research programs are needed to address the needs for health protection
of workers in delivery of such materials and services in the field.
Clearly a program is needed to identify potential hazards in small
businesses, characterize the health and safety potential problems,
develop cost-effective control recommendations and effectively transfer
these recommendations to the small business sector.

Research Scope and Goals

The purpose of this RFA is to stimulate epidemiologic studies of cancer
in the workplace and to enhance related cancer prevention and control
efforts.  Innovative approaches that include new diagnostic or exposure
measurements are particularly encouraged.  Applications that may have
substantial impact on public health are encouraged.  Projects should be
proposed as traditional R01s.  Applications that build upon ongoing
research projects, utilizing already collected epidemiologic data or
biospecimens, are encouraged.

One important goal of this initiative is to assess the extent that
occupational exposures contribute to cancer incidence and mortality
among minority populations, underserved groups, and women, and to
develop effective means of cancer control in these special populations.

The initiative permits a wide range of epidemiologic investigations
including studies directed towards modifying lifestyle behavior.
Examples of areas of research that are considered to be responsive to
this RFA include, but are not limited to:

(1) Analytic epidemiologic studies to clarify the relation of specific
occupational exposures to specific tumors, and if possible to evaluate
the impact of changing exposures on time trends in cancer incidence.
Once discovered, the information must be disseminated to workers in the
study, and to regulatory agencies, management, unions, and other labor
and industry associations.

(2) Epidemiologic studies of occupational cancer that include molecular
and biochemical components to more precisely identify previous
exposures, intermediate outcomes or susceptibility states among
particular groups of workers who are then targeted for cancer control
interventions in the proposed research.  Molecular epidemiologic
studies could explore differences in predisposition to occupational
cancer due to variations in metabolic patterns, DNA repair, formation
of adducts, chromosome sensitivity to mutagens, or others, especially
in minority populations and women, with appropriate cancer control
interventions.  The significance of biochemical or molecular analysis
would be conveyed to the subjects along with suggested methods of
reducing cancer risks.

(3) Intervention studies with lifestyle changes, chemopreventive agents
or cancer screening modalities involving population groups previously
exposed to occupational carcinogens.

(4) Intervention studies of engineering control, work practice
modification, and use of protective equipment, with evaluation of
success of interventions and assessment of applicability in other
settings.

(5) Cancer control intervention studies to address the impact of
occupational exposures to carcinogens on the minority populations of
the United States.

(6) Cancer surveillance activities to utilize existing occupational
data resources to identify occupational cancer risks among minority
populations and women.

(7) Educational interventions to inform populations-at-risk about the
potential consequences of exposures to occupational carcinogens,
especially as they relate to minorities and women.

(8) Special research areas for small business might include the
identification and characterization of potential hazards in small
businesses, development of recommendations for cost effective
engineering, administrative, and personal protective controls,
communication of recommendations to small businesses; or education of
small businesses and the public and industrial health community
regarding hazards in small businesses and their control.

(9) Engineering control research might include observational studies
conducted in the workplace to document health hazard controls, to
evaluate their performance, and to disseminate this information;
investigative research to identify sources of worker exposure and
subsequent development and demonstration of corrective measures.  These
later studies provide a much better understanding of the "etiology of
occupational exposure" than previously has been possible using
traditional workplace sampling.  For example, it has been shown that in
many cases, there are a few hazardous parts of the job that contribute
most of the actual exposure.  The seriousness of these exposure points
was not at all apparent by observation.  Intervention to control
exposures at these specific hazardous points can then be much more
focused, effective, supportable, and cheaper than attempts to reduce
exposures without specific knowledge of the exposure profile.

SPECIAL REQUIREMENTS

Applicants should include, in the budget, funds for the principal
investigator (and advisory board representative if a board exists) to
attend an annual program meeting to be held in alternating locations of
Bethesda, MD and Cincinnati, OH (or Morgantown, WV).

Proposed studies must have components that provide cancer control
activities, such as recommendations for substitute chemicals and for
specific changes in work practices and engineering controls,
informational and educational programs for workers, unions, and
management, and dissemination of results to regulatory agencies, and
other interested parties from labor and industry.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH-sponsored
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43)
and supersedes and strengthens the previous policies (Concerning the
Inclusion of Women in Study Populations, and Concerning the Inclusion
of Minorities in Study Populations) which have been in effect since
1990.  The new policy contains some new provisions that are
substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research," which was reprinted in the Federal
Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting
errors in the earlier publication, and reprinted in the NIH GUIDE FOR
GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the program
staff or contact person listed under INQUIRIES.  Program staff may also
provide additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are requested to submit, by January 10, 1995, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the names of other key personnel and participating
institutions, and the number and title of the RFA in response to which
the application may be submitted.

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 NCI and NIOSH staff to estimate the potential review workload
and to avoid conflict of interest in the review.  The letter of intent
is to be sent to Dr. Richard L. Bragg at the address listed under
INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on form PHS 398 (rev. 9/91) available
at most
institutional offices of sponsored research and from the Office of
Grants
Information.  Division of Research Grants, National Institutes of
Health,
Westwood Building, Room 449, Bethesda, MD 20892, telephone
301-435-0714.  The
format and instructions applicable to regular research grant
applications must
be followed.

Applicants from institutions that have a General Clinical Research
Center
(GCRC) funded by the NIH National Center for Research Resources may
wish to
identify the GCRC as a resource for conducting the proposed research.
If so,
a letter of agreement from either the GCRC program director or
Principal
Investigator could be included with the application.

The RFA label available in application form PHS 398 (rev. 9/91) must be
affixed to the bottom of the face page.  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 number and title
of the
RFA must be typed on line 2a of the face page of the application and
YES must
be checked.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, exact, clear and single-sided photocopies,
in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, applicants must send two additional copies
of the application to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard MSC 7405
Executive Plaza North, Room 636
Bethesda, MD  20892-7405

Failure to submit these copies may delay the review and subsequent
possible consideration of an application for award in FY 1995.

Applications must be received by February 17, 1995.  If an application
is received after that date, it will be returned without review.  If
the application submitted in response to this RFA is substantially
similar to a research grant application already submitted to the NIH
for review, but has not yet been reviewed, the applicant will be asked
to withdraw either the pending application or the new one.
Simultaneous submission of identical applications will not be allowed,
nor will essentially identical applications be reviewed by different
review committees.  Therefore, an application cannot be submitted in
response to this RFA that is essentially identical to one that has
already been reviewed.  This does not preclude the submission of
substantial revisions of applications already reviewed, but such
applications must include an introduction addressing the previous
critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG and
responsiveness by the NCI and NIOSH.  Incomplete applications will be
returned to the applicant without further consideration.  If NCI and
NIOSH staff find that the application is not responsive to the RFA, it
will be returned 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 NCI in accordance with the review criteria
stated below.  As part of the initial merit 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
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 second level
of review by the National Cancer Advisory Board considers the special
needs of the NCI and the priorities of the National Cancer Program.
The second level of review by NIOSH will consider the number of workers
affected by the hazard under study and the potential contribution to
applied technical knowledge in the prevention of occupational cancers.

Review criteria for RFAs are the same as those for unsolicited research
grant applications:

o  scientific, technical, or medical significance and originality of
proposed research;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal Investigator
and staff, particularly but exclusively in the area of the proposed
research;

o  availability of resources necessary to perform the research.

o  Adequacy of plans to include both genders and minorities and thier
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.

AWARD CRITERIA

The earliest anticipated date of award is September 29, 1995.
Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding
decisions:

o  quality of the proposed project as determined by peer review;
o  reasonableness of the budget in comparison with other applications;
o  program balance among research areas.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.

Richard L. Bragg, Ph.D.
Division of Cancer Prevention and Control
National Cancer Institute
6130 Executive Boulevard MSC 7395
Executive Plaza North, Suite 240
Bethesda, MD  20892-7395
Telephone:  (301) 496-8589
FAX:  (301) 496-8675

A.R. Patel, Ph.D.
Divisionof Cancer Etiology
National Cancer Institute
6130 Executive Boulevard MSC 7395
Executive Plaza NOrth, Suite 535
Bethesda, MD  20892-7395
Telephone:  (301) 496-9600
FAX:  (301) 402-4279

Roy M. Fleming, Sc.D.
National Institute of Occupational Safety and Health
1600 Clinton Road, NE
Building l, Room 3053, Mail Stop D-30
Atlanta, GA  30333
Telephone:  (404) 639-3343
FAX:  (404) 639-2196
Email:  rmf2@niood1.em.cdc.gov

Direct inquiries regarding fiscal matters to:

Ms. Cynthia Mead
Grants Research Branch
National Cancer Institute
6120 Executive Boulevard MSC 7395
Executive Plaza South, Suite 243
Bethesda, MD  20892-7395
Telephone:  (301) 496-7800, Ext. 254

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
Nos. 93.393 and 93.894.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-140, as
amended by Public Law 99.158, 42 USC 241 and 285) and administered
under HHS policies and grant regulations.  This program is not subject
to the intergovernment review requirements of Executive Order 12372 or
Health System Agency review.

The Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

.

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