RESEARCH METHODS FOR OCCUPATIONAL CANCER

Release Date:  August 19, 1999

PA NUMBER:  PA-99-148

National Institute for Occupational Safety and Health
National Cancer Institute
National Institute of Environmental Health Sciences

THIS PROGRAM ANNOUNCEMENT (PA) 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
PA.

PURPOSE

The Centers for Disease Control and Prevention (CDC) and  the National
Institutes of Health (NIH) invite grant applications for research related to
the priority areas that are described in the RESEARCH OBJECTIVES section.  One
type of grant will be supported under this announcement:  traditional research
project grants (R01).

The purpose of this initiative is to stimulate research for  developing
knowledge that can be used in preventing occupational cancers and to better
understand their underlying pathophysiology.  This area of research is one of
the subtopics of the National Occupational Research Agenda (NORA) which is
supported by several components of the Public Health Service within the CDC
and the NIH.  Within CDC, the National Institute for Occupational Safety and
Health is the only Federal Institute responsible for conducting research and
making recommendations for the prevention of work-related illnesses and
injuries; however, there are other Federal components that contribute
significantly to the research base for understanding the causes of
occupational illnesses and injuries.  Broad statements of interest for the
sponsors of this program announcement are given below, and more information
about their individual interests may be found on their respective internet
sites.

The National Institute of Occupational Safety and Health (NIOSH) supports
research to identify and investigate the relationships between hazardous
working conditions and associated occupational diseases and injuries; to
develop more sensitive means of evaluating hazards at work sites, as well as
methods for measuring early markers of adverse health effects and injuries; to
develop new protective equipment, engineering control technology, and work
practices to reduce the risks of occupational hazards; and to evaluate the
technical feasibility or application of a new or improved occupational safety
and health procedure, method, technique, or system.

The National Cancer Institute (NCI) supports training and research in the
basic, population-based, and clinical sciences relating to the cause,
detection, prevention, diagnosis, and treatment of cancer.  Investigations are
supported to advance cancer control methods and strategies by identifying
factors (e.g., exogenous exposures, genetic susceptibility, behavioral and
lifestyle patterns)that may influence cancer risk in individuals and
subpopulations and by developing and applying methods of surveillance and
health information dissemination.

The National Institute of Environmental Health Sciences (NIEHS) supports
research to reduce the burden of human illness and dysfunction, including
cancer, from exposure to physical and chemical agents in the environment by
understanding the interactions between environmental exposures, individual
susceptibility and time.

HEALTHY PEOPLE 2000

CDC and NIH are 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 program
announcement 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, or at http://www.crisny.org/health/us/health7.html

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.  Racial/ethnic
minority individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators.

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.

MECHANISMS OF SUPPORT

Support of this program announcement will be through the National Institutes
of Health (NIH) individual research project grants (R01) award mechanism.

Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts.  Complete and detailed
instructions and information on Modular Grant applications can be found at
https://grants.nih.gov/grants/funding/modular/modular.htm

RESEARCH OBJECTIVES

The purpose of this initiative is to stimulate the development of new methods
to address etiologic and intervention questions pertaining to occupational
cancers.  These methods should be of particular utility in addressing problem
issues with contemporary and future cancer hazards including low level
exposures, mixtures, inherited host factors, and interaction with non-
occupational, environmental risk factors. The advances of molecular biology,
analytical chemistry and the genome project should be incorporated, whenever
possible, to enhance and strengthen proposed studies and to integrate
molecular biologic approaches in epidemiologic study designs.

Research applications are sought to develop, validate, and field test methods
for predicting and identifying potential new occupations carcinogens;
developing early warning systems for exposed populations; testing
interventions; and enhancing cross-species extrapolations.  Research
applications are sought also to improve retrospective exposure assessment, to
find new ways to focus on understudied populations, such as women and
minorities, and to better assess the occupational role in transgenerational
cancers.  There is also a need to find new ways and approaches for
interrupting the etiologic and natural pathways between an occupational
exposure and resultant cancers.

Although there is a broad range of methodologic research for all cancers, less
is underway for occupational cancers.  This announcement pertains specifically
to new research methods relating to occupational cancers and carcinogens,
their detection and prevention.

SPECIAL REQUIREMENTS

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.

It is the policy of the CDC and the NIH that women and members of minority
groups and their sub-populations must be included in all supported 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.

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.  It is also available at:
https://grants.nih.gov/grants/guide/notice-files/not94-100.html

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 CDC and NIH to ensure that individuals of both sexes
and the various racial and ethnic groups will be included in 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: https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

LOBBYING RESTRICTIONS

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. Section 1352, 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 no part of CDC appropriated funds, 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 or any State or local legislature, except in presentation to the
Congress or any State or local legislature itself. No part of the appropriated
funds 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 or local legislature.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application receipt dates indicated
in the application kit.  These forms are available at most institutional
offices of sponsored research and from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive,
MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: 
[email protected].  Application kits are also available at:
https://grants.nih.gov/grants/forms.htm

Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised to contact the Institute program
staff before submitting the application, i.e., as plans for the study are
being developed.  The applicant must obtain agreement from the program staff
that the Institute will accept the application for consideration for award. 
Finally, the applicant must identify, in a cover letter sent with the
application, the staff member and Institute who agreed to accept assignment of
the application.  Refer to the NIH Guide for Grants and Contracts, March 20,
1998 at https://grants.nih.gov/grants/guide/notice-files/not98-030.html.

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.  The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up to
a total direct cost request of $250,000 per year. (Applications that request
more than $250,000 direct costs in any year must follow the traditional PHS
398 application 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:

PHS 398

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 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 - Prepare a Modular Grant Budget Narrative
page. (See https://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.  This is not a Form page.

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. However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.

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.  Include the Letter of
Intent to establish a consortium.

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:
https://grants.nih.gov/grants/funding/modular/modular.htm

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

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. All appropriate exclusions must be applied 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.

The title and number of the program announcement 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 five signed, 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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral
guidelines.  An appropriate scientific review group convened in accordance
with the standard NIH peer review procedures will evaluate applications for
scientific and technical merit.  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 appropriate national
advisory council or board.

Review Criteria

In the written comments reviewers will be asked to discuss the following
aspects of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals. Each of
these criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. Note that the
application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

(1) Significance: Does this study address an important problem? 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?

(2) Approach: Are the conceptual framework, design, 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?

(3) Innovation: Does the project employ novel concepts, approaches or method?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?

(4) 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)?

(5) 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 evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.

o The reasonableness of the proposed budget and duration in relation to the
proposed research.

o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.

AWARD CRITERIA

Applications will compete for available funds with all other recommended
applications.  The following will be considered in making funding decisions:
quality of the proposed project as determined by peer review, availability of
funds, and institutional program priority.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Roy M. Fleming, Sc.D.
Research Grants Program
National Institute for Occupational Safety and Health
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-30
Atlanta, GA  30333
Telephone:  (404) 639-3343
FAX:  (404) 639-4616
Email:  [email protected]

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:  [email protected]

Gwen W. Collman, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-21
Research Triangle Park, NC  27709
Telephone:  (919) 541-4980
FAX:  (919) 541-4937
Email: [email protected]

Direct inquiries regarding grants management matters to:

Joanne Wojcik
Procurement and Grants Office
Centers for Disease Control and Prevention
2920 Brandywine Road, MS-E13
Atlanta, GA  30341-4146
Telephone:  (770) 488-2717
FAX:  (770) 488-2777
Email:  [email protected]

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:  [email protected]

David Mineo
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-22
Research Triangle Park, NC  27709-2233
Telephone:  (919) 541-1373
FAX:  (919) 541-2860
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.262 NIOSH; 93.393 NCI; and 93.113 and 93.115 NIEHS.  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.

The CDC and NIH strongly encourage 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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