MOLECULAR EPIDEMIOLOGY OF PROSTATE CARCINOGENESIS
Release Date: March 23, 2000
PA Number: PA-00-080
National Cancer Institute
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Environmental Health Sciences
THIS 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.
This Program Announcement (PA) replaces PA-99-055, which was published in the
NIH Guide on January 29, 1999.
PURPOSE
The National Cancer Institute (Divisions of Cancer Control and Population
Sciences, Cancer Prevention, and Cancer Biology), the National Institute of
Diabetes and Digestive and Kidney Diseases (Division of Kidney, Urologic, and
Hematologic Diseases), and the National Institute of Environmental Health
Sciences (Division of Extramural Research and Training) invite
investigator-initiated research grant applications of molecular epidemiologic
studies for advancement in understanding prostate cancer development and
progression. The purpose of this initiative is to stimulate development and
application of biological markers of prostate cancer risk and tumor
aggressiveness and for utilization in chemoprevention studies. Of special
interest are studies of markers to elucidate multiethnic differences in
prostate cancer susceptibility.
This PA will expire in two years from the first receipt date. NIH Grants
policies apply to these awards.
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 area of cancer. This PA, Molecular
Epidemiology of Prostate Cancinogenesis, is related the priority area of
cancer. Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by foreign and domestic, for-profit and
non-profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as principal
investigators.
MECHANISM OF SUPPORT
Support of this program will be through the National Institutes of Health
(NIH) individual research project grants (R01). Responsibility for the
planning, directing, 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 PA may not exceed 4 years. Because the nature and scope
of the research proposed in response to this PA may vary, it is anticipated
that the size of an award will also vary.
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
RESEARCH OBJECTIVES
Background
In the United States, prostate cancer has become the most frequently
diagnosed neoplasm and the second leading cause of cancer mortality in men
after lung cancer (SEER Prostate Cancer Trends, 1973-95 at
http://seer.cancer.gov/Publications/ProstMono/). Its incidence
rate has continued to increase rapidly during the past two decades,
especially in men over the age of 50 years, and 184,500 new incident cases
are expected to be diagnosed in 1998. Prostate cancer develops more rapidly
with advancing age than any other form of cancer and with the present trend
toward an aging population, its impact is a major public health concern.
The etiology of prostate cancer is obscure. Clues may be derived from
descriptive epidemiology characterizing the steep slope of incidence with
advancing years, variation in race-specific and international incidence
patterns, and high prevalence of latent (clinically silent and histologically
apparent) carcinoma. The most compelling hypothesis supports a hormonal
etiology based on the androgen-dependency of the prostate gland for growth
and function. Studies in animal models have demonstrated the role of
androgens in the induction of prostate cancer. Moreover, in humans, men
castrated before puberty do not develop prostate cancer, and prostate cancer
has responded to estrogen therapy. Case-control studies of serum
testosterone and other hormones have thus far, however, reported inconsistent
results, although it has been reported that populations with high levels of
serum testosterone have an increased incidence of prostate cancer.
Past studies of familial aggregation and genetic analyses have indicated a
heritable component in risk. Recent investigations have suggested that
prostate cancer risk is related to certain polymorphic genes that regulate
androgen metabolism, particularly the androgen receptor (AR) gene, and the
steroid 5-alpha-reductase type II (SRD5A2) gene. In addition, there has been
interest in the cytochrome p450c17alpha (CYP17) gene, which encodes the
enzyme involved in testosterone biosynthesis, and the 3beta-hydroxysteroid
dehydrogenase type II (HSD3beta2) gene which encodes enzymes involved in
metabolism of dihydrotestosterone. Furthermore, there is some evidence
relating hereditary prostate cancer to loci on chromosomes 1q and chromosome
X, while some cases appear to arise in association with familial breast
cancer in relation to BRCA1 and 2.
The consistently wide geographic variation in rates as well as results of
migrant studies suggest a role for environmental factors, including diet and
nutrition. African American men have the highest incidence and mortality
rates in the world, almost 1.5 times higher than among U.S. whites and much
higher than among African populations. The incidence varies widely around
the world: a 65-fold difference exists between countries with the highest
(blacks in U.S. SEER: 137 per 100,000) and lowest (Shanghai, China: 2 per
100,000) incidence rates of prostate cancer. In addition, immigrants from
low-risk countries (e.g., China or Japan) experience an increased risk after
migrating to a high-risk country (e.g., United States). Evidence from
case-control and cohort studies has suggested that dietary fat may be
associated with invasive prostate cancer while certain micronutrients such as
vitamin D, vitamin E, and selenium may be protective. The role of other
environmental exposures (e.g., occupation, ionizing radiation, viruses) is
inconclusive while the effects of lifestyle factors (e.g., smoking, alcohol
consumption, sexual behavior, body mass, physical activity, vasectomy) have
yet to be clarified.
The special characteristic of latent prostatic tumors, detected most often at
autopsy and estimated to affect one third of all males older than 50 years,
has remained an enigma in our understanding of the natural history and
biology of invasive prostate cancer. Interestingly, there are no clear
racial or geographic differences in the occurrence of small intraprostatic
foci of latent cancer, whereas the prevalence of larger focal lesions
parallels the variations in mortality rates. It has been hypothesized that
environmental factors may affect the transition of latent to invasive cancer
by acting as tumor promoters. Little is known about the molecular events and
processes involved in the progressive transition to invasive cancer.
Although genetic alterations in several chromosomes (e.g., 5, 8, 10, 16, 17,
18, and 22) have been reported in relation to prostate carcinogenesis, the
association with tumor initiation and progression remains to be elucidated.
Research Goals and Scope
The purpose of this initiative is to stimulate innovative molecular
epidemiologic research into the origins and progression of prostate cancer.
Interdisciplinary collaborations, which may include multicenter study sites
as well as joint effort between NIH/NCI intramural and extramural scientists,
are encouraged. These collaborations may include utilization of shared
laboratory and specimen resources whenever possible. Applications will be
welcomed from investigators who are participating in ongoing collaborative
organizations such as the George M. O"Brien Kidney and Urologic Research
Centers, the Specialized Programs of Research Excellence in Prostate Cancer
(SPORES), the NIEHS Environmental Health Sciences Centers and the General
Clinical Research Centers (GCRCs). Proposed research duplicating that which
is currently supported should not be submitted. Proposals to expand an
ongoing epidemiologic study by the addition of a laboratory component will be
considered. Transitional molecular epidemiology studies characterizing and
validating biomarkers while determining optimal biological specimens and the
most suitable procedures for collection, processing, and storage are
encouraged. Selected measurements or biomarkers should be relevant to the
processes of prostate carcinogenesis. Additionally, the utility of hormonal
and surrogate or intermediate biomarkers should be demonstrated with an
evaluation of sensitivity, specificity, intra- and inter-individual
variability.
Investigations in understudied populations and in populations of contrasting
risk, including those who are residing outside of the U.S., are strongly
encouraged. Establishment of cohorts of young and older men for
participation in longitudinal studies as well as of resources such as
germline DNA repositories and tumor tissue banks with clinical and
epidemiologic databases is highly recommended. There is continued interest
in ascertainment of high-risk families, particularly African-American, to
accelerate gene identification and functional research.
This PA invites a range of interdisciplinary investigations, including
molecular epidemiologic, family, or population-based studies of prostate
cancer, utilizing available or new/novel biomarkers (e.g., biochemical,
molecular, cellular, genetic) and sources of specimens (e.g., prostate
tissue, prostatic fluid, blood components) whenever possible. Examples of
topics of interest to the participating NIH institutes include, BUT ARE NOT
LIMITED TO, the areas listed below.
I. NCI (in response to relevant recommendations of the NCI Prostate Cancer
Review Group, a committee of members of the scientific, medical, industrial,
and advocacy communities with the goal of developing a national plan for
pursuing scientific opportunities in prostate cancer research, refer to URL
address: http://www.nci.nih.gov under "What’s New")
o Etiology and tumor progression
- differences in genetic predisposition due to variations (polymorphisms) in
susceptibility and low-penetrance genes, DNA repair activities, cell cycle
progression, chromosome sensitivity to mutagens or in hormonal metabolism
- gene-environment interactions for understanding modification of prostate
cancer risk and influence on tumor progression
- suspected premalignant processes (e.g., morphological changes) as
independent or joint risk factors with, for example, hormones, nutrition,
genetic components, exogenous exposures that contribute to the transition
from latent to invasive cancer
- biologic characteristics in pre-cancerous lesions and tumor, such as
malignancy associated changes, heterogeneity or clusters of small foci, that
can better define the natural history of prostate cancer and predict
prognosis
o Biomarkers
- assessment and validation of genetic and epigenetic markers that predict
tumor progression from localized to disseminated prostate cancer
- validation of existing biomarkers of risk (e.g., androgen receptor
mutations, 5-alpha-reductase isoenzymes, epithelial cell receptors, hormonal
panels including insulin growth factor) in human populations with
simultaneous consideration of biological variables (e.g., age, ethnicity,
genetic predisposition, hormonal profiles, pre-existing disease) and
lifestyle risk factors
- identification, assessment, and validation of novel biomarkers for early
detection and diagnosis, including comparison with current indicators such as
PSA
- development and clinical validation of new biological markers associated
with prostate cancer biology (e.g., apoptosis, cell cycle control) with
determination of their role in responses to specific forms of systemic
therapy
- development and validation of surrogate markers (e.g., nuclear chromatin
texture as quantitated by image analysis) that can serve as intermediate
endpoints for intervention or clinical trials testing preventive modalities
o Diet and lifestyle factors
- identification of dietary nutrients affecting prostate cancer risk and
mechanisms of action by which risk is altered
- pilot intervention studies of dietary nutrients (e.g., phytoestrogens,
micronutrients such as vitamins D and E, lycopene, selenium)
- role of lifestyle factors (e.g., smoking, alcohol intake), occupational and
environmental exposures (e.g., pesticides, viruses), sexual behavior,
anthropometry
- effect of dietary intake (e.g., fat, micronutrients such as vitamin D,
calcium, beta-carotene) singly and jointly or interacting with endogenous
parameters (e.g., growth factors, steroid receptors, androgen conjugates)
o Primary prevention
- evaluation, including mechanisms of action and affected stages of
carcinogenesis and inhibition, of promising preventive agents based on
selection of tumor characteristics most amenable to preventive strategies
- identification and characterization of suspected premalignant processes
(e.g., prostatic intraepithelial neoplasia or PIN, dysplasia, atypical
adenomatous hyperplasia) as potential intermediate markers for intervention
trials
II. NIDDK
o Identification of risk factors (e.g., environmental, hormonal, viral
exposure, sexually transmitted diseases, lifestyle, ethnicity) associated
with benign prostatic hyperplasia or chronic prostatitis and clarification of
their possible relationships to the development of prostate cancer
III. NIEHS (reflecting the January 1998 announcement of the Environmental
Genome Project (EGP) to understand the role of environmental response genes
on human susceptibility to environmental agents, extensive background
information on the EGP is available at the following URL:
http://www.niehs.nih.gov/envgenom
o Elucidation of the role of environmental response genes (e.g., genes which
control the distribution and metabolism of toxicants, genes for DNA repair
pathways, genes for cell death and differentiation, receptor genes, etc.) in
the development of prostate cancer
o Enhanced understanding of the impact of occupational and environmental
exposures on the risk of prostate cancer including interactions with genetic
factors
o Exploration and elucidation of the role of timing of environmental
exposures during critical periods of normal prostate gland development (e.g.,
fetal period, childhood, puberty) relevant to future risk of carcinogenesis
including, but not limited to:
(a) cellular, genetic, and hormonal effects of environmental exposures on
normal and abnormal prostate growth and development, and (b) mechanisms by
which environmental exposures acting as initiating or promoting agents at
various time periods affect the risk and latency of prostate cancer
SPECIAL REQUIREMENTS
Awardees under this PA are strongly encouraged to participate in a one-day
meeting of investigators to be held in Bethesda, Maryland, during the last
year of the grant. Program directors from the NCI, NIDDK, and NIEHS will
coordinate this meeting which will provide the opportunity for principal
investigators to discuss their proposals and work in progress as well as any
cross-disciplinary methodological and scientific issues. Applicants may
request sufficient funds in the budget to accommodate expenses for one to two
participants to attend the meeting.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that members of minority groups and their
subpopulations must be included in all NIH-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. 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
"NIH Guidelines on the 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 available at the following
URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html
Applications received in response to this PA are expected to focus on
scientific issues related to prostate cancer. In describing the plan to
recruit human subjects, investigators may cite a focus on prostate cancer as
the justification for why women will be excluded. In this regard applicants
may use Justification 1 from the policy announcement: the research topic to
be studied is irrelevant to women.
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/or 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
"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
Applications received in response to this PA are expected to focus on
scientific issues related to prostate cancer. In describing the plan to
recruit human subjects, investigators may cite a focus on prostate cancer as
the justification for why children will be excluded. In this regard
applicants may use Justification 1 from the policy announcement: the research
topic to be studied is irrelevant to children.
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.
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit. 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 301/710-0267, email: grantsinfo@nih.gov. For applicants with Internet access, the
398 kit may be found at: http://grants.nih.gov/grants/forms.htm
The PA title and number must be typed on line 2 of the face page of the
application form and the YES box must be marked.
Applicants are strongly encouraged to call the program contacts listed in
INQUIRIES below with any questions regarding responsiveness of their proposed
project to the goals of this PA.
SPECIAL INSTRUCTIONS FOR MODULAR GRANT APPLICATION PROCEDURES
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:
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.
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 and organizations with whom consortium
and contractual arrangements have been made, the percent effort of key
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.
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.
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 identified and
applied in the calculation of the F&A costs for the initial budget period and
all future budget years.
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 that he or she must contact the Institute program
staff before submitting the application, i.e., as plans for the study are being
developed. Furthermore, the application must obtain agreement from the
Institute 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.
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.
Submit a signed, typewritten original of the application, including the
checklist, and five 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)
REVIEW CONSIDERATIONS
Applications will be assigned on the basis of established PHS referral
guidelines. Applications will be evaluated for scientific and technical merit
by an appropriate scientific review group convened in accordance with the
standard NIH peer review procedures. As part of the initial merit review, all
applications will receive a written critique and undergo a process in which
only those applications deemed to have the highest scientific merit,
generally the top half of applications under review, will be discussed,
assigned a priority score, and receive a second level review by the
appropriate national advisory council or board.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. 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.
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?
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?
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?
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)?
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 the
proposed project budget and duration, the adequacy of plans to include
minorities and their subgroups as appropriate for the scientific goals of the
research and plans for the recruitment and retention of subjects, the
adequacy of plans to include children as appropriate for the scientific goals
of the research, or justification for exclusion, the provisions for the
protection of human and animal subjects, and the safety of the research
environment.
AWARD CRITERIA
Applications will compete for available funds with all other recommended
applications. NCI intends to additionally consider meritorious applications
responding to this PA for funding by exception. The following will be
considered in making funding decisions: quality of the proposed project as
determined by peer review, availability of funds, and Institute/program
priorities.
INQUIRIES
Inquiries concerning this PA are encouraged, particularly during the planning
phase of the grant applications. The opportunity to clarify any issues or
questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Dr. Kumiko Iwamoto
National Cancer Institute
Executive Plaza North, Suite 535
Bethesda, MD 20892-7395
Telephone: (301) 435-4911
FAX: (301) 402-4279
Email: ki6n@nih.gov
Dr. Leroy Nyberg
National Institute of Diabetes and Digestive and Kidney Diseases
Natcher Building, Room 6AS-13G
Bethesda, MD 20892
Telephone: (301) 594-7717
FAX: (301) 480-3510
Email: nybergl@extra.niddk.nih.gov
Dr. Gwen W. Collman
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709
Telephone: (919) 541-4980
FAX: (919) 541-4937
Email: collman@niehs.nih.gov
Direct inquiries regarding fiscal matters to:
William Wells
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 243
Bethesda, MD 20892
Telephone: (301) 496-8796
FAX: (301) 496-8601
Email: wellsw@gab.nci.nih.gov
Trude McCain
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
Natcher Building, 6AN-44J
Bethesda, MD 20892
Telephone: (301) 594-8859
FAX: (301) 480-4237
Email: hilliardt@extra.niddk.nih.gov
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
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 Part 74 and 92. This program is not subject to intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant recipients 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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