EXPOSURE ASSESSMENT METHODS FOR CANCER RESEARCH

Release Date:  December 20, 2000

RFA:  CA-01-018


National Cancer Institute
National Institute of Environmental Health Sciences

Letter of Intent Receipt Date:  February 19, 2001
Application Receipt Date:       April 19, 2001

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 Division of Cancer Control and Population Sciences of the National Cancer 
Institute (NCI) and the Division of Extramural Training and Research of the 
National Institute of Environmental Health Sciences (NIEHS) invite 
exploratory/developmental R21 grant applications from  investigators to 
develop, improve, and/or validate environmental exposure assessment methods 
applicable in epidemiologic research on cancer.  Of special interest will be 
methods and markers that can be potentially useful in studies of environmental 
epidemiology focusing on tumor initiation (etiology) and exogenous 
environmental factors, other than infectious agents.  Consideration of bio-
behavioral and psychosocial measurements as secondary or confounding factors 
associated with environmental exposures and cancer risk may be included.          

The exploratory/developmental (R21) grant mechanism is used for pilot projects 
or feasibility studies to support creative, novel, high risk/high payoff 
research that may produce innovative advances in science.  Historically, 
mechanisms designed to stimulate and fund basic bio-behavioral research have 
not existed as they have for basic biomedical research.   Thus, it has been 
difficult for scientists to obtain funding for these activities through the 
traditional investigator-initiated research project grant (R01) mechanism.

This RFA encourages applicants to, for example, gather data to determine the 
practicability of a method or approach; to explore the validity of various 
approaches, including statistical modeling, prior to their incorporation in an 
epidemiologic study; and to characterize factors that may limit quantitation 
of environmental exposures relevant to cancer risk.  Studies are not to be 
used to provide preliminary research data for research grant applications but 
may confirm or extend previous preliminary results that can be of significant 
usefulness in establishing exposure assessment protocols and evaluations.  
Proposed research duplicating that which is currently supported should not be 
submitted.

RESEARCH OBJECTIVES

Background

Recent scientific and biotechnological advances, particularly in molecular 
biology and genetics, have provided new insights and research directions into 
the pathogenesis of cancer.  Identification of candidate genes, such as BRCA1 
and BRCA2 in breast/ovarian cancer and the familial adenomatous polyposis 
(FAP) gene in colon cancer, has led to a better understanding of cancer 
susceptibility and risk for a small percentage of the general population.  
However, for many malignancies, why some individuals subsequently develop 
cancer while others do not remains an enigma.   It has been estimated that 
environmental factors contribute to 75-80% of all cancers, which are, thus, 
considered potentially avoidable (1).  Whether the effects of environmental 
exposures may be multiple or may vary according to cancer type, e.g., as 
cancer risk factors, modifiers of gene expression in carcinogenesis, or as 
variables interacting with other factors, such as genetic and behavioral, are 
research questions of widespread scientific interest.   Characterization of 
environmental determinants of cancer continues to be an important goal for 
developing effective public health strategies in prevention and control of 
cancer. 

Informative epidemiologic investigations of environment-cancer relationships, 
including cancer risk, rely on accurate, quantifiable exposure measurements.   
To date, traditional research instruments estimate exposure to carcinogens by 
surrogate measures in questionnaire or personal interview data.   The 
inexactness of this estimation, magnified by the long interval of time   
between putative exposure(s) and cancer detection, has obscured or limited 
identification of cancer etiologies.  Biomarkers of exposure (e.g., blood 
levels of pesticides) and effect (e.g., DNA adducts) promise to be potentially 
applicable in studies of carcinogenesis.   Methodological  issues, including 
exposure measurement error, and research gaps in exposure assessment for 
studies in environmental/occupational epidemiology have been a continuing 
concern during the past decade (2-5).  

The pivotal role of exposure assessment in evaluating health effects of the 
environment has led to collaborative, coordinated efforts by several Federal 
agencies, e.g., NIH institutes, Centers for Disease Control and Prevention 
(CDC), and U.S. Environmental Protection Agency (EPA), to jointly support the 
expansion and improvement of this science.   In September 1999 a trans-NIH 
workshop, “The Role of Human Exposure Assessment in the Prevention of 
Environmental Disease,” organized by NIEHS, addressed the current status and 
opportunities for exposure assessment, using examples of health effect studies 
in chronic diseases, cancer, and reproductive health.   The first result of 
the workshop discussions is RFA ES-00-009 (6), a request for SBIR (Small 
Business Innovation Research) applications in “Development of Technology-
Driven Products/Devices/ Biomarkers for Measuring Exposure to Environmental 
Agents.”   The initiative strives to integrate biotechnology with 
bioengineering, imaging techniques, and advances in molecular biology to 
revolutionize the field of exposure assessment.   Awards will be funded in 
fiscal year 2001. 
An advisory session of interdisciplinary participants within the workshop was 
also convened by the NCI and NIEHS extramural programs.   The group, 
comprising cancer and occupational/ environmental epidemiologists as well as 
environmental scientists, identified and discussed immediate research needs 
(to be achieved within 5 years) for improved exposure assessment in 
environment-cancer studies.   These needs are incorporated in this RFA (refer 
to the following “Research Goals and Scope”) and represent, for NCI, one of 
the extraordinary opportunities for research investment (Genes and the 
Environment) in the Bypass Budget for 2002 (7).      

Research Goals and Scope

This initiative proposes to stimulate interdisciplinary research to develop, 
test, validate, and compare technology, methods, and biomarkers that could 
provide more accurate estimates of retrospective and current environmental 
exposures (e.g., chemical and physical substances) relevant to cancer 
development.  Quality control strategies should be included.  Collaborations 
that may include multicenter study sites, established infrastructures for 
resources such as the Cancer Genetics Network, the Cancer Family Registries, 
other registries, large cohort populations or case series, and interactions 
between NIH/NCI intramural and extramural scientists are encouraged.   
Applications will be welcomed from researchers participating in ongoing 
collaborative organizations such as the NCI Specialized Programs of Research 
Excellence (SPORES), the NIEHS Environmental Health Sciences Centers, 
NIEHS/EPA Children’s Health Centers, and NIEHS Superfund Basic Research and 
Training Program.   Investigations in understudied populations and in 
populations with contrasting exposures, including those who are residing 
outside of the U.S., are encouraged.   Research that is complimentary to or 
derived from an ongoing investigation (i.e., parent study) may be proposed, 
contingent upon the continuation of the parent study for at least two years.  

Examples of topics that may be proposed include, but are not limited to the 
following (no order of priority although retrospective methods will be of 
special interest): 

Technique or method of quantifying exposures
o  direct measurements and/or technology, cost-effective, reliable and simple, 
for large-scale population studies
o  assessment of the effects of space, time, and location on exposure levels 
o  development, validation, and improvement of biomarkers of exposure or 
effect or as surrogates of exposure, e.g., by time-series and pharmacokinetic 
data 
o  development and validation of questionnaires to obtain body burden data and 
cumulative environmental exposures, taking into account confounders and effect 
modifiers such as age, gender, socio-economic status, and bio-behavioral 
characteristics
o   assessment and estimation of low level exposures
o  statistical methods, e.g., geographic exposure/spatial modeling, exposure 
ranking systems, modeling of exposure monitoring data, minimizing exposure 
measurement error

Characterization of exposures and exposed populations   
o  exposure reconstruction for retrospective exposures
o  suitability and requirements for use of biological specimens (e.g., body 
fluids, surrogate tissue, target tissue) to obtain exposure data, including 
selection of best measure of the exposure (e.g., chemical agent, metabolites, 
reactive products)
o  total exposure profiles for individuals  that consider multiple sources 
(e.g., air, water, food), multiple types (e.g., dermal, respiratory), and 
multiple sites (e.g., residential, occupational, and/or general environmental) 
of exposure
o  characterization of variability in individuals, e.g., body burden, 
biologically effective dose levels, effect of polymorphisms of metabolizing 
enzymes  
o  detection and determination of exposure levels to chemical mixtures
o  small field studies to characterize exposure routes and sources, e.g., use 
of videotaping and time-activity diaries to assess children’s exposures

Correlations, comparisons, and validation
o  use of group level exposures to estimate individual level exposures with 
validation
o  correlation of exposure data from questionnaires and direct measurements
o  feasibility of utilizing survey data (e.g., National Human Exposure 
Assessment Survey, NHEXAS), surveillance, and bio-monitoring data   

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) 
exploratory/developmental (R21) grant mechanism.  Responsibility for the 
planning, direction, and execution of the proposed project will be solely that 
of the applicant.  The total project period for an application submitted in 
response to this RFA may not exceed THREE years.  These grants are 
non-renewable and continuation of projects developed under this RFA will be 
through the traditional, unsolicited investigator-initiated grant program.  
Amended applications will be accepted.   The earliest anticipated award date 
is September 30, 2001.

Though the size of award may vary with the scope of research proposed, it is 
expected that applications will stay within the budgetary guidelines for an 
exploratory/developmental project.   Applicants may request up to $125,000 
direct costs (five budget modules) per year unless the application includes 
consortium costs, in which case the limit is $150,000 direct costs (six budget 
modules) per year. 

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

FUNDS AVAILABLE

The estimated funds (total costs) available for the first year of support for 
this program is $2 million. The NCI and NIEHS intend to commit the $2 million 
in FY 2001 to fund approximately 9 to 12 new  grants in response to this RFA.   
Because the nature and scope of the research proposed may vary, it  is 
anticipated that the size of each award will also vary.  Although the 
financial plans of NCI and NIEHS provide support for this program, awards 
pursuant to this RFA are contingent upon the availability of funds and the 
receipt of a sufficient number of applications of outstanding scientific and 
technical merit. 

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges, 
research institutions, hospitals, small, minority, and/or women-owned 
businesses, state and local governments or their bona fide agents, and 
federally recognized Indian tribal governments, Indian tribes, or Indian 
tribal organizations.   

INQUIRIES

Inquiries concerning this RFA are encouraged.   The opportunity to clarify any 
issues or questions from potential applicants are welcome.   Inquiries 
regarding programmatic issues may be directed to:

Dr. Kumi Iwamoto 
Division of Cancer Control and Population Sciences    
National Cancer Institute
6130 Executive Boulevard, Suite 5104, MSC 
Bethesda, MD 20892-7324 
Telephone: (301) 435-4911   
Fax: (301) 402-4279    
Email:    iwamotok@mail.nih.gov

Dr. Gwen Collman     
Division of Extramural Research and Training    
National Institutes of Environmental Health Sciences     
P.O. Box 12233    
Research Triangle Park, NC 27709   
Telephone: (919) 541-4980   
Fax: (919) 316-4606     
Email:  collman@niehs.nih.gov

Direct inquiries regarding review issues to:
Ms. Toby Friedberg 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Boulevard, Suite 8109, MSC 8239  
Rockville, MD 20852 (express courier)
Bethesda MD 20892
Telephone (301) 496-3428
Fax: (301) 402-0275
Email:  tf12w@nih.gov 

Direct inquiries regarding fiscal matters to:
Ms. Joy McCauley       
Grants Administration Branch         
National Cancer Institute     
Executive Plaza South, Suite 243        
Bethesda, MD 20892          
Telephone: (301) 496-7206    
Fax: (301) 496-8601   
Email: jm165@nih.gov
 
Ms. Dorothy G. Duke
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709
Telephone: (919) 541-2749
Fax: (919) 541-2860
Email:  duke3@niehs.nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit, by February 19, 2001, 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 not enter into the 
review of a subsequent application, the information that it contains allows 
NCI staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent to the program staff listed under INQUIRIES 
by the letter of intent receipt date listed in the heading of this RFA.

SCHEDULE

Letter of Intent Receipt:         February 19, 2001
Application Receipt:              April 19, 2001
Peer Review Date:                 June/July, 2001
Review by NCAB Advisory Board:    September, 2001
Earliest Anticipated Start Date:  September 30, 2001

APPLICATION PROCEDURES
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. Applications 
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.  
For those applicants with internet access, the 398 kit may be found at: 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

Applicants are strongly encouraged to call the program contacts listed in 
INQUIRIES above with any questions regarding the responsiveness of their 
proposed project to the goals of this RFA.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up to 
a total direct cost request of $125,000 per year ($150,000 if there are 
consortium/contractual costs).   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) 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 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.  This is not a form page.

o  Under Personnel, list all 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 all personnel, and the role 
on the project. Indicate whether the collaborating institution is domestic or 
foreign.  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:
  http://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.

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.

Applications 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 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.   Type the RFA 
number on the label.  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.

The sample RFA label available at:  
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change. Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the 
checklist, and three signed, exact, 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 be 
sent to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8239
Bethesda, MD  20892-8239
Rockville, MD  20852 (for express/courier service) 

Applications must be received by April 19, 2001.  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 by CSR and 
responsiveness by the NCI and NIEHS.  Incomplete and/or non-responsive 
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 NCI in accordance with the review criteria stated below. As part of the 
initial merit review, a process will be used by the initial review group in 
which applications 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 the applications under review will be discussed, assigned a 
priority score, and receive a second level review by the National Cancer 
Advisory Board and the National Advisory Environmental Health Sciences 
Council. 

Review Criteria

The five criteria to be used in the evaluation of grant applications are 
listed below.
The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health. The 
reviewers will comment on the following aspects of the application in their 
written critiques 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 by the reviewers 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 a 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 methods? 
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?

The initial review group will also examine: the appropriateness of proposed 
project budget and duration; the adequacy of plans to include both genders and 
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.

AWARD CRITERIA

The following will be considered when making funding decisions:   quality and 
scientific merit of the proposed project as determined by peer review, 
programmatic priorities, and the availability of funds. 

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 sub- populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43). 

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000  
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm,  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

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 clear and compelling 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

Investigators may also obtain copies of these policies from the program staff 
listed under INQUIRIES.   Program staff may also provide additional relevant 
information concerning the policy.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

Effective October 1, 2000, the NIH requires education on the protection of 
human research participants for all investigators submitting NIH application 
for grants or proposals for contracts or receiving new or non-competing awards 
for research involving human subjects.

All investigators proposing research involving human subjects should read the 
above-referenced policy that was published in the NIH Guide for Grants an 
Contracts, June 5, 2000 (Revised August 25, 2000), and is available at the 
following URL address 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.   Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.   Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010 

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of “Healthy People 2010,” a PHS-led national 
activity for setting priority areas.   This RFA, Exposure Assessment Methods 
for Cancer Research, is related to priority area of cancer.   Potential 
applicants may obtain a copy of “Healthy People 2010" at 
http://www.health.gov/healthypeople/

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.393, 93.849, and 93.894.   Awards are made under authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and administered under NIH grants policies and Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92.   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 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.

REFERENCES

1.  Zahm SH, Fraumeni, Jr. JF, Davis DL.   The Avoidable Causes of Cancer in 
President’s Cancer Panel Conference on Avoidable Causes of Cancer (April 7-8, 
1994), Environ Health Perspect 103 (Suppl 8): 129, 1995.

2.   Armstrong B and Boffetta P.   Measurement of Exposure and Outcome in 
Epidemiological Studies Used for Quantitative Estimation and Prediction of 
Risk in Quantitative Estimation and Prediction of Risk in Quantitative 
Estimation and Prediction of Human Cancer Risks, edit S Moolgavkar, D Kewski, 
L Zeise et al.  Lyon, France IARC Sci Publ #131: 75-102, 1999.

3.   Rothman K.  Methodologic Frontiers in Environmental Epidemiology,  
Environ Health Perspect 101 (Suppl 4): 19-21, 1993.

4.   Hatch M and Thomas D.  Measurement Issues in Environmental Epidemiology,  
Environ Health Perspect 101 (Suppl 4): 49-57, 1993.

5.   International Workshop on Retrospective Exposure Assessment in 
Occupational Epidemiologic Studies, edit RA Herrick and PA Stewart in Appl 
Occup Environ Hyg 6 (No. 6): 417-559, 1991.

6.   RFA ES-00-009, “Development of Technology-Driven 
Products/Devices/Biomarkers for Measuring Exposure to Environmental Agents.”  
Application receipt date November 16, 2000.  NIH Guide website 
http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-00-009.html.

7.   Opportunity 1:  Genes and the Environment in The Nation’s Investment in 
Cancer Research   Bethesda, MD: National Cancer Institute, NIH publication No. 
00-4373: 64-68, October 2000.

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