MECHANISTIC-BASED CANCER RISK ASSESSMENT METHODS

Release Date:  April 15, 1999

RFA:  OH-99-003

P.T.

National Institute for Occupational Safety and Health
National Center for Environmental Research and Quality Assurance
National Cancer Institute

Letter of Intent Receipt Date:  May 26, 1999
Application Receipt Date:  July 14, 1999

THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE

The Centers for Disease Control and Prevention (CDC), the United States
Environmental Protection Agency (EPA), and the National Institutes of Health,
National Cancer Institute (NCI) announce the availability of fiscal year (FY)
1999 funds for grant applications for research related to mechanistic-based
cancer risk assessment methods.  The following type of grant will be supported: 
traditional research projects (see "MECHANISMS OF SUPPORT" section).

This research focus is part of a priority area identified in the National
Occupational Research Agenda (NORA), which was developed in 1996 by NIOSH and its
partners in the public and private sectors.  NORA provides a framework to guide
occupational safety and health research into the next decade รพ not only for
NIOSH, but also for the entire occupational safety and health community.  The
research needs identified in this RFA are consistent with the NORA but are
limited to the targeted areas in the "RESEARCH OBJECTIVES" section.

HEALTHY PEOPLE 2000

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 Request For Applications (RFA)
is related to the priority areas of "Occupational Safety and Health" and
"Unintentional Injuries."  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, public and private
nonprofit and for-profit organizations and by governments and their agencies;
that is, universities, colleges, research institutions, hospitals, other public
and private nonprofit and for-profit organizations, State and local governments
or their bona fide agents, and federally recognized Indian tribal governments,
Indian tribes, or Indian tribal organizations

Note:  Public Law 104-65 states that an organization described in section
501(c)(4) of the Internal Revenue Code of 1986 which engages in lobbying
activities is not eligible to receive Federal funds constituting an award, grant
(cooperative agreement), contract, loan, or any other form.

FUNDS AVAILABLE

Approximately $1.55 million is available to fund the first budget year of five
to six grants under this RFA.  The approximate amounts that are expected to be
available by each Institute are as follows: NIOSH - $0.55M, EPA - $0.7M, and NCI
- $0.25M.  It is expected that requested budgets would range up to $250,000 in
total costs (direct plus indirect) per year.  Higher budgets may be requested,
but only if a strong justification is provided.  Awards are expected to begin in
September 1999, although some awards may not begin until FY 2000.  Only
applications that are found to be of high scientific merit will be considered for
funding, and not all of the funds will be spent if there are not enough highly
meritorious applications.

For NIOSH and NCI, 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 in future years.

For EPA, initial awards will be made for the full project periods.  Approximately
$2.0M is available for total funding of all years combined for all projects
awarded.  Therefore, no continuation awards will be made in future years.

MECHANISMS OF SUPPORT

The mechanism of support will be the individual research project grant (R01). 
The total requested project period for an application submitted in response to
this RFA may not exceed three years.  However, specific application instructions
have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining
efforts being examined by the NIH.  The modular grant concept establishes
specific modules in which direct costs may be requested as well as a maximum
level for requested budgets. Only limited budgetary information is required under
this approach. The just-in-time concept allows applicants to submit certain
information only when there is a possibility for an award.  It is anticipated
that these changes will reduce the administrative burden for the applicants,
reviewers and Institute staff. Complete and detailed instructions and information
on Modular Grants can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm.

Applications will request direct costs in $25,000 modules, up to a total direct
cost request of $250,000 per year (however, see "FUNDS AVAILABLE" for guidance
on budget).  A typical modular grant application will request the same number of
modules in each year.

Application budgets will be simplified.  Detailed categorical budget information
will not be submitted with the application; budget form pages of the application
kits will not be used.  Instead, total direct costs requested for each year will
be presented.  Information, in narrative form, will be provided only for
Personnel and, when applicable, for Consortium/Contractual Costs.  See section
on APPLICATION PROCEDURES below.

Additional narrative budget justification will be required in the application
only if there is a variation in the number of modules requested.

There will be no routine escalation for future years. In determining the total
for each budget year, applicants should first consider the direct cost of the
entire project period. Well-justified modular increments or decrements in the
total direct costs for any year of the project that reflect substantial changes
in expected future activities may be requested. For example, purchase of major
equipment in the first year may justify a higher overall budget in the first, but
not in succeeding years.

Other Support pages of the PHS 398 will not be submitted with the application. 
Information on research projects ongoing or completed during the last three years
of the principal investigator and key personnel will be provided as part of the
"Biographical Sketch."  This information will include the specific aims, overall
goals and responsibilities and should include Federal and non-Federal support. 
This information will be used by reviewers in the assessment of each individuals
qualifications for a specific role in the proposed project.

Following peer review, information about Other Research Support will be requested
from the applicant for applications being considered for award.  Additional
budget information will be requested only under special circumstances.

This RFA is a one-time solicitation. Future unsolicited competing continuation
applications will compete with all investigator-initiated applications and be
reviewed according to the customary peer review procedures.  Responsibility for
the planning, direction, and execution of the proposed project will be solely
that of the applicant.

Research Project Grants (R01) - A research project grant application should be
designed to establish, discover, develop, elucidate, or confirm information
relating to occupational safety and health, including innovative methods,
techniques, and approaches for addressing problems.  These studies may generate
information that is immediately useful to solve problems or that will contribute
to a better understanding of the causes of work-related diseases and injuries.

RESEARCH OBJECTIVES

Background

The goal of NIOSH is to support research essential for setting occupational
safety and health priorities and for demonstrating health impairment when
promulgating occupational standards.  Risk assessment has been most often applied
in assessing the risk of carcinogens, often with animal bioassay data.  However,
evaluation of these procedures has been limited, and questions abound as to
whether the resulting risk estimates are reasonable.  Risk assessment for
noncarcinogens, particularly qualitative approaches, is even less well developed. 
Improved methods are needed for using animal bioassay data and human health
effects data to generate risk estimates for cancer and noncancer effects and
injury.

The mission of EPA is to protect both environmental quality and human health
through effective regulations and other policy initiatives.  Achievement of this
mission requires the application of sound science to assessment of environmental
problems and to evaluation of possible solutions.  A significant challenge is to
support both long-term research that anticipates future environmental problems
as well as research that fills gaps in knowledge relevant to meeting current
Agency goals.  EPA's research programs focus on reduction of risks to human
health and ecosystems and on the reduction of uncertainty associated with risk
assessment.  Through its laboratories and through grants to academic and other
not-for-profit institutions, EPA promotes research in both domains, according the
highest priority to those areas in which risk assessors are most in need of new
concepts, methods, and data.  EPA also fosters the development and evaluation of
new risk reduction technologies across a spectrum, from pollution prevention
through end-of-pipe controls to remediation and monitoring.  In all areas, EPA
is interested in research that recognizes issues relating to environmental
justice, the concept of achieving equal protection from environmental and health
hazards for all people without regard to race, economic status, or culture.

The NCI is the principal Federal funding agency that supports laboratory and
clinical investigations relating to the cause, prevention, diagnosis, and
treatment of cancer.  Of special interest are epidemiological studies
incorporating molecular technology and/or quantitative methods and methodological
developments that can assess the role of occupational or environmental risk
factors in the etiology of human cancer.

Research Goals

Animal bioassay data are frequently used to estimate risks to humans from
environmental and occupational exposures to toxic agents in spite of concerns
that these assays may have limitations as predictors of human risk.  Rodent
cancer bioassay data, for example, are generated from late or terminal stages of
complex sequences of events and processes that are determined by both genotype
and phenotype and can differ considerably between rodents and humans.  Also,
bioassays are carried out at doses that may exceed relevant human exposures. 
Risk estimations based on bioassay data, therefore, may not be an accurate
reflection of the risks to human health from exposure to toxic agents.

In order to more accurately estimate risks to humans from exposures to toxic
agents, it is important that risk assessment methods and practices be continually
evaluated and improved upon in light of new scientific information.  A large body
of information that has important consequences for assessing the validity of
current methodologies, and implementing their improvement, comes from the fields
of molecular and cellular biology.  Over the last decade these disciplines have
increased our understanding of the basic pathways and processes that control cell
growth, differentiation, and death; they have also provided new insights into how
these pathways and processes can be subverted by toxic agents.  While many
pathways and processes are common to all eukaryotic cells, there are clear
phenotypic and genotypic differences that can cause toxic responses to be cell
type- and species-specific.  This can profoundly affect how animals and humans
respond to the same toxic agent.  These insights into molecular and cellular
mechanisms gained over the last decade of basic research need to be incorporated
into current risk assessment methods and practices.

This RFA solicits studies that focus on the development of cancer risk assessment
methods and practices.  Emphasis should be on the development of new methods and
practices that reduce the uncertainties associated with cancer risk assessment,
especially uncertainties that are encountered in extrapolating from animal
species to humans.  Studies that propose refinement, validation, or invalidation
of existing methods and practices are also acceptable if they will result in a
significant reduction in uncertainty.  Methods development can be based on in
vitro and/or in vivo animal model systems, in vitro human cell model systems, and
exploratory epidemiologic approaches.  Short-term, mechanistic-based methods that
can be used to augment long-term bioassays are also encouraged.  A clear and
unambiguous demonstration of mechanistic commonality with humans is a requirement
of any method based on animal model systems.

SPECIAL REQUIREMENTS

Applicants will be expected to budget for and participate in an annual All-
Investigators Meeting with NIOSH, EPA, and NCI scientists in Washington D.C. and
other grantees to report on research activities and to discuss issues of mutual
interest.

Human Subjects

If a project involves research on human subjects, assurance (in accordance with
Department of Health and Human Services Regulations, 45 CFR Part 46) of the
protection of human subjects is required.  In addition to other applicable
committees, Indian Health Service (IHS) institutional review committees also must
review the project if any component of IHS will be involved with or will support
the research.  If any American Indian community is involved, its tribal
government must also approve that portion of the project applicable to it. 
Unless the grantee holds a Multiple Project Assurance, a Single Project Assurance
is required, as well as an assurance for each subcontractor or cooperating
institution that has immediate responsibility for human subjects.  The Office for
Protection from Research Risks (OPRR) at the National Institutes of Health (NIH)
negotiates assurances for all activities involving human subjects that are
supported by the Department of Health and Human Services.

Animal Subjects Requirements

If the proposed project involves research on animal subjects, compliance with the
"PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions"
is required.  An applicant (as well as each subcontractor or cooperating
institution that has immediate responsibility for animal subjects) proposing to
use vertebrate animals in CDC-supported activities must file (or have on file)
the Animal Welfare Assurance with the Office for the Protection from Research
Risks (OPRR) at the National Institutes of Health. The applicant must provide in
the application the assurance of compliance number and evidence of review and
approval (including the date of the most recent approval) by the Institutional
Care and Use Committee (IACUC).

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the Centers for Disease Control and Prevention (CDC) to
ensure that individuals of both sexes and the various 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 or Alaska Native, Asian, Black
or African American, Hispanic or Latino, Native Hawaiian or Other Pacific
Islander.  Applicants shall ensure that women, racial and ethnic minority
populations are appropriately represented in applications for research involving
human subjects.  Where clear and compelling rationale exist that inclusion is
inappropriate or not feasible, this situation must be explained as part of the
application.  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,
pages 47947-47951, and dated Friday, September 15, 1995.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

LETTER OF INTENT

Prospective applicants are asked to submit, by May 26, 1999, a letter of intent
that includes a descriptive title of the proposed research, 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 in
response to which the application may be submitted.  Although a letter of intent
is not required, is not binding, and does enter into the review of a subsequent
application, the information that it contains allows the participating Institutes
and Centers to estimate the potential review workload and avoid conflict of
interest in the review.

The letter of intent is to be submitted to:

Roy M. Fleming, Sc.D.
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-30
Atlanta, GA  30333
Telephone 404-639-3343; Fax 404-639-4616
Email:  rmf2@cdc.gov

APPLICATION PROCEDURES

Applicants must use Form PHS 398 (rev. 4/98).  Application kits are available at
most institutional offices of sponsored research and may be obtained from the
Division of Extramural Outreach and Information Resources, National Institutes
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/435-0714,  Email: grantsinfo@nih.gov.  Application kits are also available
at: grants.nih.gov/grants/forms.htm.

BUDGET INSTRUCTIONS

The total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398 application
instructions described below:

o  FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $250,000) and Total Costs  [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period. (However, see "FUNDS AVAILABLE" for guidance on budget.)  Items 8a and
8b should be completed indicating the Direct and Total Costs for the entire
proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required and
will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page. 
(See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At
the top of the page, enter the total direct costs requested for each year.

o  Under Personnel, List key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should be
provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct plus
facilities and administrative) for each year, each rounded to the nearest $1,000.
List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and the role
on the project. Indicate whether the collaborating institution is foreign or
domestic. The total cost for a consortium/contractual arrangement is included in
the overall requested modular direct cost amount.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall qualifications
of the research team. A biographical sketch is required for all key personnel,
following the instructions below. No more than three pages may be used for each
person. A sample biographical sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page; - List current
position(s) and then previous positions; - List selected peer-reviewed
publications, with full citations; - Provide information, including overall goals
and responsibilities, on research projects ongoing or completed during the last
three years.

o  CHECKLIST - This page should be completed and submitted with the application. 
If the F&A rate agreement has been established, indicate the type of agreement
and the date. It is important to identify all exclusions that were used in the
calculation of the F&A costs for the initial budget period and all future budget
years.

o  The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information is
necessary following the initial review.

Applicants not conforming to these guidelines will be considered unresponsive to
this RFA and will be returned without further review.

The RFA label available in the PHS 398 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.

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.

Submit a signed, typewritten original, including the checklist, and three signed,
clear, and single sided photocopies in one package to:

CENTER FOR SCIENTIFIC REVIEW
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 also be
sent to Dr. Roy M. Fleming at the address under LETTER OF INTENT.

Applications must be received by July 14, 1999. If an application is received
after that date, it will be returned to the applicant without review.  The Center
for Scientific Review (CSR) will not accept any application in response to this
RFA that is essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  The CSR will not accept any
application that is essentially the same as one already 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 and responsiveness
(applicants should clearly indicate which priority area of this RFA is being
addressed by their proposal) and will be assigned to the appropriate sponsoring
federal agency or institute for funding consideration.  Applications determined
to be incomplete or unresponsive to this RFA will be returned to the applicant
without further consideration.

Applications that are complete and responsive to the RFA (see "Quality Assurance
Narrative Statement" below) will be reviewed for scientific and technical merit
by an initial review group.  Reviewers will identify those applications with the
highest scientific merit, which generally comprise the top half of applications
reviewed.  Those applications will be discussed fully and assigned a priority
score between 100 and 300 (100 is the best possible score).  For all other
applications, there will be a limited discussion and they will not be scored. 
Notification of the scientific review results will be sent to the applicants
after the initial review.

Following the initial review, applications will receive a secondary review for
programmatic importance.  For applications assigned to EPA, the programmatic
review will be conducted within their Agency.  For NCI, the review will be
conducted by their Council.

Review Criteria
(also see "Quality Assurance Narrative Statement" below):

o  Significance - Does this study address an important problem related to the
topical research issues outlined in this solicitation?  If the aims of the
application are achieved, how will scientific knowledge be advanced?  What will
be the effect of these studies on the concepts or methods that drive this field?

o  Approach - Are the conceptual framework, design (including composition of
study population), methods, and analyses adequately developed, well-integrated
and appropriate to the aims of the project?  Does the applicant acknowledge
potential problem areas and consider alternative tactics?

o  Innovation - Does the project employ novel concepts, approaches or methods? 
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?

o  Investigator - Is the investigator appropriately trained and well suited to
carry out this work?  Is the work proposed appropriate to the experience level
of the principal investigator and other researchers, if any?

o  Environment - Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?  Is there documentation of cooperation from industry,
unions, or other participants in the project, where applicable?  Is there
evidence of institutional support and availability of resources necessary to
perform the project?

The initial review group will also examine the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders,
minorities and their subgroups, and children as appropriate for the  scientific
goals of the research and plans for the recruitment and retention of subjects;
the provisions for the protection of human and animal subjects; and the safety
of the research environment.

The personnel category will be reviewed for appropriate staffing based on the
requested percent effort. The direct costs budget request will be reviewed for
consistency with the proposed methods and specific aims.  Any budgetary
adjustments recommended by the reviewers will be in $25,000 modules.  The
duration of support will be reviewed to determine if it is appropriate to ensure
successful completion of the requested scope of the project.

Review Criteria for Programmatic Importance are as follows:

o  Magnitude of the problem in terms of numbers of workers affected.

o  Severity of the disease or injury in the worker population.

o  Usefulness to applied technical knowledge in the identification, evaluation,
or control of occupational safety and health hazards on a national or regional
basis.

o Propensity to improve understanding of the cause, diagnosis, treatment, and
prevention of adverse health or safety outcomes caused by occupational exposures.

Quality Assurance Narrative Statement

EPA regulations require the inclusion of a Quality Assurance Narrative Statement
for any project involving data collection or processing, conducting surveys,
environmental measurements, and/or modeling, or the development of environmental
technology (whether hardware-based or via new techniques) for pollution control
and waste treatment.  This statement should not exceed two consecutively
numbered, 8.5x11-inch pages of single-spaced standard 12-point type with 1-inch
margins.  This statement is to be considered as additional information and is not
counted against the 25 pages permitted for the Research Plan.  The Quality
Assurance Narrative Statement should, for each item listed below, either present
the required information or provide a justification as to why the item does not
apply to the proposed research.  For awards that involve environmentally related
measurements or data generation, a quality system that complies with the
requirements of ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems
for Environmental Data Collection and Environmental Technology Programs," must
be in place.

1.  The activities to be performed or hypothesis to be tested (reference may be
made to the specific page and paragraph number in the application where this
information may be found); criteria for determining the acceptability of data
quality in terms of precision, accuracy, representativeness, completeness,
comparability.  (Note: these criteria must also be applied to determine the
acceptability of existing or secondary data to be used in the project.

2.  The study design, including sample type and location requirements and any
statistical analyses that were used to estimate the types and numbers of samples
required for physical samples or similar information for studies using survey and
interview techniques.

3.  The procedures for the handling and custody of samples, including sample
identification, preservation, transportation, and storage.

4.  The methods that will be used to analyze samples or data collected, including
a description of the sampling and/or analytical instruments required.

5.  The procedures that will be used in the calibration and performance
evaluation of the sampling and analytical methods used during the project.

6.  The procedures for data reduction and reporting, including a description of
statistical analyses to be used and of any computer models to be designed or
utilized with associated verification and validation techniques.

7.  The intended use of the data as they relate to the study objectives or
hypotheses.

8.  The quantitative and or qualitative procedures that will be used to evaluate
the success of the project.

9.  Any plans for peer or other reviews of the study design or analytical methods
prior to data collection.

ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems for
Environmental Data Collection and Environmental Technology Programs" is available
for purchase from the American Society for Quality Control, phone 1-800-248-1946,
item T55.  Only in exceptional circumstances should it be necessary to consult
this document.

AWARD CRITERIA

Final funding decisions are based on the recommendations of the initial
(technical merit) and secondary (programmatic importance) reviews, balance of
awards across areas of programmatic interest in this RFA, and availability of
funds.  Awards are expected to begin in September 1999, although some awards may
not begin until FY 2000.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.  This RFA and other CDC
Announcements can be found on the CDC HomePage (www.cdc.gov) under the "Funding"
section.  This RFA can also be found on the NIOSH HomePage (www.cdc.gov/niosh)
under "Extramural Program."

Potential applicants may obtain a copy of the "National Occupational Research
Agenda" (HHS, CDC, NIOSH Publication No.96-115) from the National Institute for
Occupational Safety and Health, telephone (800) 356-4674.  It is also available
on the internet at "http://www.cdc.gov/niosh/nora.html".

Direct inquiries regarding programmatic issues to:

Roy M. Fleming, Sc.D.
Director, Research Grants Program
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-30
Atlanta, GA  30333
Telephone: 404/639-3343
FAX: 404/639-4616
Email:  rmf2@cdc.gov

David Reese, Ph.D.
U.S. Environmental Protection Agency
National Center for Environmental Research and Quality Assurance
401 M. Street, S.W.
Washington, D.C.  20460
Telephone: 202/564-6919
FAX: 202-565-2448
Email: reese.david@epamail.epa.gov

Kumiko Iwamoto, M.D., Dr.P.H.
Epidemiology and Genetics Research Program
National Cancer Institute
6130 Executive Boulevard, Room 535
Bethesda, MD  20892-7395
Telephone:  (301) 435-4911
FAX:  (301) 402-4279
Email:  ki6n@nih.gov

Direct inquiries regarding grants management matters to:

Joanne Wojcik
Grants Management Branch
Procurement and Grants Office
Centers for Disease Control and Prevention
2920 Brandywine Road, Suite 3000
Atlanta, GA 30341-4146
Telephone: 770/488-2717
FAX: 770/488-2777
Email: jcw6@cdc.gov

Mr. Jack Puzak
National Center for Environmental Research and Quality Assurance
U.S. Environmental Protection Agency
401 M. Street. S.W. (8701R)
Washington, D.C.  20460
Telephone:  202/565-6825
FAX: 202/565-2444
Email: puzak.jack@epamail.epa.gov

Mr. William Wells
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800, ext. 250
FAX:  (301) 496-8601
Email:  wellsw@gab.nci.nih.gov

AUTHORITY AND REGULATIONS

The Catalog of Federal Domestic Assistance number is: 93.262 for the National
Institute for Occupational Safety and Health (NIOSH) and 93.393 for the National
Cancer Institute (NCI).  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, Section 20(a) [29 U.S.C. 669(a)].  The applicable
program regulation is 42 CFR Part 52.  EPA awards are made under authority of 40
CFR Part 30 and 40.  This program is not subject to the intergovernmental review
requirements of executive order 12372 or Health Systems Agency Review.

SMOKE-FREE WORKPLACE

CDC, EPA, and PHS strongly encourage all grant recipients to provide a smoke-free
workplace and 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, and
early childhood development services are provided to children.



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