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Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
November 9, 2006 |
 EGRP BULLETIN
From the Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
Contents
- EGRP Will Be at AACR Frontiers in Cancer Prevention Research Conference,
Nov. 12-15, 2006
- Funding Opportunities
- Coming Soon: EGRP PAs in Epigenetics and Prediction Models
for Cancer Risk and Prognosis
- EGRP Cosponsors NIH Genes and Environment
Initiative: RFAs Issued, Deadlines Nov. 29, 2006, and Jan.
11, 2007
- Ongoing Funding Opportunities Sponsored
by EGRP
- NIH Sponsors Pathway to Independence Award
- Cancer Epidemiology Small Business and Business-Research Grant
Opportunities, NIH Annual Meeting, Las Vegas, Feb. 26-27, 2007
- NIH Loan Repayment Program for Post-Docs, Deadline Dec. 1,
2006
- News
- Grantsmanship
- EGRP-Supported Research Resources
- New Publications
- Sources of Information on Grant Policies, Funding, and Training
EGRP Will Be at AACR Frontiers in Cancer Prevention Research Conference
Look for us at the Frontiers in Cancer Prevention Research Conference,
sponsored by the American Association for Cancer Research(AACR), in Boston,
November 12–15. You are welcome to contact us in advance by e-mail
to schedule a time to meet. We also will be taking our tabletop exhibit
with the latest EGRP Bulletin and Research Highlights.
The following EGRP staff are attending:
   Program Directors:
J. Fernando Arena, M.D., Ph.D.,
e-mail: arenaj@mail.nih.gov;
Virginia (Ginny)
Hartmuller, Ph.D., R.D., e-mail: hartmulv@mail.nih.gov; and
Shannon
Lemrow, Ph.D., Program Director, e-mail: lemrows@mail.nih.gov.
   Program
Analysts:
Nonye Harvey, M.P.H., e-mail: harveyn@mail.nih.gov;
Shannon
Lynch, M.P.H., e-mail: lynchs@mail.nih.gov;
and
Scott Rogers, M.P.H., e-mail: rogerssc@mail.nih.gov.
  Communications:
Linda Anderson, M.P.A., Director of Communications; and
Stephanie Eber, M.P.H., Associate Communications Coordinator.
The poster “Trends in Cancer Incidence Among Adults Under Age
50, United States, 1975–2003” will be presented by Ms.
Lynch and Mr. Rogers from 6 to 8 p.m., Tuesday, November 14,
at the General Epidemiology and Biostatistics Poster Session. Isis
Mikhail, M.D., M.P.H., Dr.P.H., and Deborah Winn,
Ph.D., EGRP Acting Associate Director, also are co-authors.
Funding Opportunities
Coming Soon: EGRP To Sponsor PAs in Epigenetics and Models for Cancer
Risk and Prognosis
By the end of the calendar year, the Epidemiology and Genetics Research Program
(EGRP) expects to be sponsoring Program Announcements (PA) soliciting research
proposals for Research Project Grants (R01) and Exploratory/ Developmental
Grants (R21) in two new areas:
- Epigenetic Approaches in Cancer Epidemiology. Epigenetics
is the study of mechanisms that involve mitotically heritable changes
in DNA other than changes in nucleotide sequence. This PA is to stimulate
population- based epidemiology research on the role of DNA methylation markers
and changes in risk for cancer.
The EGRP contact will be Mukesh Verma, Ph.D.,
Acting Chief, AERB; e-mail: vermam@mail.nih.gov.
- Development, Application, and Evaluation of Prediction Models
for Cancer Risk and Prognosis. This PA is to encourage clinicians
and researchers to improve existing models for cancer risk and prognosis
by developing innovative research projects that use existing data to
develop new models as well as to validate these models and evaluate their
utility in research and clinical settings. (In 2004, EGRP cosponsored Cancer
Risk Prediction Models: A Workshop on Development, Evaluation, and Application;
the meeting report was published in the Journal of the National Cancer
Institute (2005 May 18;97(10):715-23).)
The EGRP contact will be
Isis Mikhail, M.D., M.P.H., Dr.P.H.; e-mail: mikhaili@mail.nih.gov.
This PA will be cosponsored with the Applied Research Program (ARP), which
also is part of our Division of Cancer Control and Population Sciences (DCCPS),
and with the Division of Cancer Treatment and Diagnosis (DCTD).
Watch for announcements of the PAs in the NIH
Guide for Grants and Contracts.
EGRP Cosponsors NIH Genes and Environment Initiative: RFAs Issued, Deadlines Nov. 29, 2006, and Jan. 11, 2007
 Early this year, NIH began the Genes and Environment Initiative (GEI) to
support research that will lead to the understanding of genetic contributions
and gene-environment interactions in common disease. GEI is being developed
and planned by an NIH-wide Coordinating Committee, administratively led by
the National Human Genome Research Institute (NHGRI) and the National Institute
of Environmental Health Sciences (NIEHS).
The initiative has a Genetics Program and an Exposure Biology Program.
Multiple Requests for Applications (RFA) have been developed and are
being issued by NHGRI, NIEHS, and other Institutes. As a trans-NIH
effort, Institutes elect to participate in one or more of the RFAs.
- Genetics Program
NCI, and specifically EGRP, is participating in the three RFAs issued
by the Genetics Program that will support genotyping facilities for
genome-wide association studies in genes and the environment (RFA-HG-06-014),
a coordinating center (RFA-HG-06-032), and individual research projects
(RFA-HG-06-033). The
Research Project Cooperative Agreement mechanism (U01) will be used
for all three types of activities. The deadline for receipt of
proposals in response to the RFAs is November 29, 2006.
- Exposure Biology Program
Five RFAs have been issued by the Exposure Biology Program. The RFA
for Improved Measures of Diet and Physical Activity for Research, RFA-CA-07-032,
is cosponsored by NCI’s Applied Research Program (ARP), which also
is part of our Division of Cancer Control and Population Sciences (DCCPS),
and the National, Heart, Lung, and Blood Institute (NHLBI). The
goal is to develop technologies or biomarkers to measure diet and physical
activity that are reliable and valid, have low respondent burden, and
are economically feasible for use in studies of free-living, diverse
populations. Letters
of Intent are due December 11, 2006, and applications are due January
11, 2007. The U01 Research Project Cooperative Agreement mechanism
will be used. Send Letters of Intent should be directed to Amy
Subar, Ph.D., M.P.H., R.D., ARP, DCCPS, NCI, e-mail: subara@mail.nih.gov. (See
the RFA for additional contact information.)
The four other RFAs, which share the same deadline for receipt of applications,
are: Environmental Sensors for Personal Exposure Assessment (RFA-ES-06-011,
U01); Field-deployable Tools for Quantifying Exposures to Psychosocial
Stress and to Addictive Substances for Studies of Health and Disease
(RFA-DA-07-005, U01); Biological Response Indicators to Environmental Stressors
Centers (RFA-ES-06-012, U54); and Biological Response Indicators to Environmental
Stressors (RFA-ES-06-013, U01). The U01 mechanism is used for these
RFAs, also.
Access the GEI Web site for links
to the RFAs and to keep up to date on additional funding opportunities.
Ongoing Funding Opportunities Sponsored by EGRP
EGRP is sponsoring or cosponsoring the following Program Announcements (PA/PAR):
NIH Sponsors Pathway to Independence Award
 Early this year, NIH launched the Pathway to Independence Award Program to
facilitate the transition of promising postdoctoral scientists to research
independence by providing opportunities to receive both mentored and independent
research support from the same award. NIH expects to award between 150 and
200 grants soon and about the same number of awards in each of the coming
5 years.
The award features an initial 1–2 year mentored phase that
allows investigators to complete their supervised research work, publish
results, and search for an independent research position. The second, independent
phase, in years 3–5, provides awardees who secure an assistant professorship
or equivalent position significant research support, including full indirect
costs that will allow them to establish their own research program and
successfully apply for an NIH investigator-initiated (R01) grant. During
the full 5-year period, NIH will provide almost $400 million in support
of the program. All NIH Institutes and Centers are participating. Learn
more about the program and watch for information on the next application
deadline on the program’s
Web site.
Cancer Epidemiology Small Business Grant Opportunities, NIH Annual
Meeting February 2007
 NIH’s small business grants programs may offer cancer epidemiologists
funding opportunities that they had not considered. The Small Business Innovation
Research (SBIR) and Small Business Technology Transfer Research (STTR) Programs
support innovative research ideas with the potential for commercialization.
The STTR Program requires close collaboration between the small business and
a partnered research institution. If you are interested, consider attending
the next annual NIH SBIR/STTR Conference to be held February 26–27,
2007, in Las Vegas, NV. Registration information will be posted on the NIH
Small Business Grants Web site. Jay
Choudhry, M.S., EGRP’s SBIR/STTR Programs Director, will attend the
conference; e-mail: choudhrj@mail.nih.gov.
EGRP is particularly interested in supporting small business research on
development of tools for assessment of exposures and biomarkers and tools
for cancer epidemiology studies. View EGRP’s list of topics of
interest in these two areas.
Note that effective January 1, 2007, the standard deadlines for submission
of SBIR and STTR Programs applications will be April 5, August 5, and December
5. These changes do not affect the December 1, 2006, or the January 2, 2007,
AIDS and AIDS-related submission dates. See the NIH Guide Notice
NOT-OD-07-001.
NIH Loan Repayment Program Offers $35,000, Deadline December 1, 2006
This year’s deadline for individuals with doctoral-level degrees to
apply for NIH’s annual student loan repayment programs is December 1. NIH
has five loan repayment programs: Clinical Research, Clinical Research for
Individuals from Disadvantaged Backgrounds, Contraception and Infertility
Research, Health Disparities Research, and Pediatric Research. Epidemiology
falls under the category of clinical research in these programs.
NIH will repay up to $35,000 annually of the qualified educational debt of
health professionals pursuing careers in biomedical and behavioral research.
The programs also provide coverage for Federal and state tax liabilities.
To qualify, applicants must possess a doctoral-level degree, devote 50 percent
or more of their time to research funded by a non-profit organization or government
entity (Federal, state, or local), and have educational loan debt equal to
or exceeding 20 percent of their institutional base salary. Applicants must
also be U.S. citizens, permanent residents, or U.S. nationals to be eligible.
All applications must be completed by 8 p.m. EST, December 1, 2006. Visit
the Loan Repayment Program Web site for information on how to apply.
News
New NCI Director Niederhuber Sworn In
 John E. Niederhuber, M.D., was sworn in as NCI Director on October 18.
The position is a Presidential appointment. He had been Acting Director
of NCI since June, and before then, he was NCI’s Chief Operating
Officer and Deputy Director for Translational and Clinical Sciences,
positions he had held since September 2005.
From 2002 until being named NCI Deputy Director, Dr. Niederhuber was
chair of the National Cancer Advisory Board (NCAB). He brings to the
directorship four decades of experience in the treatment and study of
cancer. He will remain involved in research in NCI’s Laboratory
of Tumor and Stem Cell Biology, which is part of the Cell and Cancer
Biology Branch, Center for Cancer Research. Under his leadership there,
researchers are studying adult tissue stem cells as the cell-of-origin
for cancer. He also holds a clinical appointment on the NIH Clinical
Center medical staff.
Dr. Niederhuber is recognized for his work in hepatic artery infusion
chemotherapy and was the first to demonstrate the feasibility of totally
implantable vascular access devices. He has experience as a grant reviewer,
professor, and external advisor to NCI, and has served as the Director
of the University of Wisconsin Comprehensive Cancer Center.
EGRP Provides Assistance To Develop Cancer Epidemiology Consortia
 EGRP
is working to facilitate and fund consortia that can conduct the types
of large-scale epidemiologic studies needed to address complex questions
about the etiology of cancer. Assistance is available through all phases
of consortia development. The Program provides assistance in numerous
ways, including through grant support, assistance in identifying partners
with similar research interests, advice on policies and processes that
have proven successful with other cancer epidemiology consortia, participation
on steering committees, and in evaluating established consortia.
View information about the types of
assistance available.
The following operating definition for a Consortium is used:
A consortium in epidemiology is a group of scientists from multiple
institutions who have agreed to cooperative research efforts involving,
but not limited to, pooling of information from more than one population
study for the purpose of combined analyses. The consortium group is able
to address scientific questions that cannot otherwise be addressed through
the effort of a team of investigators at a single institution due to
scope, resources, population size, and need for an interdisciplinary
approach. The cooperation usually involves multiple projects over an
extended time. Groups participating in a consortium may partner in the
writing of research grant applications, but consortia activities are
not limited to a specific grant/project.
Creation of a consortium is independent from funding mechanisms and
does not indicate definite grant support; however, EGRP and its staff
can provide supportive activities and tools.
The Program currently is facilitating and/or funding about 30 cancer
epidemiology consortia. View information about on them on our Web
site.
Daniela Seminara, Ph.D., M.P.H., is EGRP Consortia Coordinator; e-mail: seminard@mail.nih.gov.
EGRP Staff News
Four new people have joined EGRP’s staff:
 Program
Analyst Diane Horn-Cruder, B.A., wears several
hats for EGRP. She is office manager, principal liaison to other
NCI and NIH administrative support programs and activities such as
procurement, property management, facilities, and other services, and
all-around trouble shooter. Ms. Horn-Cruder has more than 22
years of military experience working as a Human Resource Manager at
the Naval Medical Research Center and National Naval Medical Hospital,
Bethesda, MD. She has her B.A. in sociology from the University of
South Alabama.
Program Analyst Shannon Lynch, M.P.H., is working on
several major EGRP initiatives. Among her duties, Ms. Lynch is the Project
Coordinator for the Breast Cancer and the Environment Research Centers
(BCERCs), a transdisciplinary research initiative jointly funded by EGRP
and the National Institute of Environmental Health Sciences (NIEHS).
She is Co-Project Officer of the contract for the Geographic Information
System for Breast Cancer Studies on Long Island (LI
GIS), a research
tool developed under the Long Island Breast Cancer Study Project (LIBCSP)
and available to investigators. In addition, she provides management
oversight for EGRP’s work in the areas of whole genome association
studies and consortia.
Ms. Lynch had been working in EGRP as a Cancer Research Training Award
Fellow prior to her appointment. She received her M.P.H. in environmental
and occupational health from George Washington University School of Public
Health. While working toward her degree, she completed a fellowship with
the U.S. Environmental Protection Agency (EPA), where she developed national
guidelines and program priorities in the area of biological and chemical
terrorism. She also worked as a biologist conducting HIV protease research
at the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) Laboratory of Chemical Physics.
Program
Analyst Scott Rogers, M.P.H., coordinates grants
management activities, serves as the principal EGRP staffer responsible
for working with the Division-level staff on grants policy and management
issues, and communicates across the Program on these issues. Mr.
Roger’s research interest is in studying the relationships between
tobacco use and cessation and genetic susceptibility, particularly in
the Alpha-Tocopherol Beta-Carotene (ATBC) Study. The ATBC Study is a
chemoprevention trial that investigated whether vitamin E and beta-carotene
could protect smokers from lung cancer. (They did not.) The research
gave Mr. Rogers the opportunity to collaborate with scientists in the
Tobacco Control Research Branch, DCCPS, and in the Division of Cancer
Epidemiology and Genetics (DCEG).
Mr. Rogers had been working for the past two years under contract. Prior
to that, he
was a senior scientist in the Department of Preventive Sciences, University
of Minnesota, where he worked with a team studying chronic pain in patients
with bone cancer and spinal cord injuries, and specialized in cellular
imaging. After 10 years of research, he returned to school to pursue
a graduate degree in public health and epidemiology and to continue his
work in cancer and chronic disease. Mr. Rogers has his B.S. in microbiology
from the University of Minnesota and M.P.H. from the University of Miami.
Stephanie
Green Eber, M.P.H., has joined EGRP as Associate
Communications Coordinator. She will be writing and disseminating information
about NCI and EGRP program activities, grantsmanship, and research resources
relevant to our grantees and prospective grantees, and communicating
about our activities and supported research to our other audiences.
Ms. Eber earned her M.P.H. and Certificate in Health Communication from
The Johns Hopkins University Bloomberg School of Public Health, and her
B.A. in English and creative writing from Emory University. She worked
as a writer and editor for Aspen System Corporation’s contract
with the NCI’s Cancer Information Service (CIS). She also has experience
as a health and technology reporter.
Research on Admixture Among Hispanic/Latino Populations Explored
 — By
J. Fernando Arena, M.D., Ph.D.
EGRP hosted a workshop to address the implications and opportunities
for cancer epidemiologic research of admixture among Hispanic/Latino
populations in the American Continents in May of this year. A summary
of the workshop is in preparation, and EGRP will
be inviting investigators to submit their suggestions and recommendations
for furthering cancer epidemiologic research in this area.
Genetic and environmental factors interacting for a prolonged time in
geographic isolation have generated normal and disease phenotypes in
populations. Well-known mechanisms of evolution, such as new gene mutations,
genetic selection, and genetic drift, have phenotypically shaped populations
in different corners of the world. Voluntary and involuntary migration
to the American Continents occurring mainly in the past five centuries
has facilitated the merging of indigenous and distant gene pools. After
centuries of regional admixture and population expansions within the
American Continents, economic, political, and social forces have triggered
in the last decades massive migrations from Central, South, and North
America toward the United States. As a result, Latin Americans now constitute
14 percent of the total U.S. population. Within the United States, Hispanic/Latino
groups are heterogeneous by their country of origin and culture, as well
as in their genetic composition.
A better understanding of the complex admixture component of the existing
gene pools in this country is necessary in order to investigate the observed
phenotypical cancer disparities and their positive and negative impact
on health and cancer risk throughout these populations in the United
States.
The meeting was organized by Dr. Arena and Mr. Rogers.
To be notified of availability of the summary of the Cancer
Epidemiology and Genomics Variation in Hispanic/Latino Populations Workshop,
contact Ms. Shannon Lynch.
Mitochondrial DNA in Cancer Epidemiology Explored
 — By Mukesh Verma, Ph.D.
In September, EGRP hosted a workshop to review the state-of-the-science
in the field of mitochondrial DNA and its use in cancer epidemiology
in order to identify populations at high risk of developing malignancies.
The workshop participants included international leaders in the fields
of mitochondrial biology, cancer epidemiology, oncology, and biotechnology.
The meeting was chaired by Keshav Singh, Ph.D., of Roswell Park Cancer
Institute, Buffalo, NY, and co-chaired by Robert Naviaux, M.D., Ph.D.,
of the University of California, San Diego. Brief talks covered the following
topics: examples of different tumor types for which mitochondrial DNA
has been used for diagnosis, interaction of nuclear and mitochondrial
genomes, mitochondrial haplogroups and cancer, other mitochondrial diseases
and cancer, and high-throughput technologies to detect mitochondrial
DNA mutations and polymorphisms.
The general consensus of the participants was that there is a need to
utilize information from the mitochondrial genome in cancer epidemiology
to understand the etiology of the disease and to utilize mitochondrial
somatic mutations and mitochondrial haplotypes in screening populations
of different ethnicities.
Mitochondria have been implicated in the process of carcinogenesis because
of their vital role in energy production, nuclear-cytoplasmic signal
integration, and control of metabolic pathways. Interestingly, at some
point during neoplastic transformation, there is an increase in reactive
oxygen species, which damages the mitochondrial genome. This accelerates
the somatic mutation rate of mitochondrial DNA. It has been proposed
that these mutations may serve as an early indication of potential cancer
development and may represent a means for tracking tumor progression.
Mitochondrial dysfunction is a hallmark of cancer cells. Mutations have
been detected in mitochondria of different tumor types, including breast,
colon, esophageal, endometrial, head and neck, hepatocellular, kidney,
leukemia, lung, melanoma, oral, prostate, and thyroid cancer. However,
it is not clear whether mitochondrial genomic status in human cells affects
nuclear genome stability and whether proteins involved in intergenomic
cross talk are involved in tumorigenesis. Somatic mitochondrial mutations
are common in human cancers, and can be used as a tool for early detection
of cancer. The majority of these somatic mutations are homoplasmic in
nature, indicating that the mutant mtDNA become dominant in tumor cells.
One approach to understand the utility of mitochondrial DNA in cancer
epidemiology is to look for the somatic mutations in mitochondria, and
the other approach is to look for disease-associated haplotypes. The
inheritance pattern of mitochondria in patients with cancer has been
studied by haplotype analysis. Polymerase chain reaction of key polymorphic
sites in the mitochondrial genome was performed in samples from cancer
patients and normal individuals to determine if there is an association
between mitochondrial genotype and cancer. Such analysis has been accomplished
in prostate and renal cancer.
A variety of clinical samples have been utilized for mitochondrial DNA
mutation detection. For example, nipple aspirate and paraffin-embedded
specimens for breast cancer, urine for bladder cancer, buccal cells for
head and neck cancer, cerebrospinal fluid for meduloblastoma, and sputum
for lung cancer have been used. High-throughput mutation analysis of
mtDNA is performed on “MitoChips” with the whole mitochondrial
genome (16.5 kb).
For epidemiologic studies in which thousands of samples are collected
and analyzed, it is very important to select which clinical samples should
be collected. The procedure should be noninvasive and not expensive.
It would be ideal to have three specific tissue types for any mtDNA study:
blood, tumor, and normal tissue adjacent to the tumor. The reason for
collecting three types of biospecimens is the existence of mitochondrial
genome in homoplasmic and heteroplasmic forms. Samples collected from
tumors and adjacent sites will indicate whether mitochondrial homoplasmy
is maintained or not. Because NCI maintains a number of cohorts (epi.grants.cancer.gov/initiatives.html),
nested case-control studies should be designed for evaluating mitochondrial
DNA markers for risk assessment. The specific topics of interest to EGRP
are:
- Will inclusion of mitochondrial markers help
to identify new risk factors (modifiable factors and host factors)
in different races and ethnic groups?
- Will mitochondrial markers in
cohort and case-control studies improve sensitivity and specificity
of markers and help in identifying high-risk populations?
- Are genetic
and mitochondrial DNA alterations (somatic mutations, deletions) correlated
during cancer development?
- Can we utilize mitochondrial haplogroup information
to identify high-risk populations?
- How can we utilize mitochondrial
proteomic information to understand gene-gene and gene-environment
studies and cancer etiology?
There is an urgent need to utilize mitochondrial DNA somatic mutations
and deletions as markers for epidemiological purposes that help us identify
high-risk populations in different races and ethnic groups. A summary
of the Mitochondrial DNA and Cancer Epidemiology Workshop is
being prepared for publication. To be notified when it is published,
contact Ms. Shannon Lynch.
View Highlights of Research by EGRP Grantees on Our Web Site
EGRP periodically selects papers published by our grantees to highlight
and post on its Web site. We can't begin to capture all the many research contributions, and welcome
your suggestions on papers about new research findings to add. We
also produce a print version of EGRP Research Highlights to
take to various conferences. View the
Web page to read about some
recent findings by our grantees.
Grantsmanship
NIH Seeks Input on Roadmap Initiatives by November 17, 2006
 NIH
is seeking input and ideas on innovative and cross-cutting initiatives
that will improve and accelerate biomedical research and its impact on
health. Comments are due by November 17, 2006. The invitation is part
of the process of identifying new “Roadmap” trans-Institute
strategic initiatives for Fiscal Year 2008. NIH Director Elias Zerhouni,
M.D., created the NIH Roadmap for Medical Research Program several years
ago to identify major opportunities and gaps in biomedical research that
no single Institute at NIH could tackle alone but that the agency as
a whole must address in order to make the biggest impact on the progress
of medical research. The first cohort of research projects was funded,
and NIH now is requesting ideas for a second cohort of initiatives on
ways to:
- address specific barriers to basic, translational,
or clinical research through development of novel tools, technologies,
services, etc., and
- fill knowledge gaps that impede research across
a broad spectrum of health science.
Submit your nominations for new ideas and comment on previously submitted
ideas at http://www.reffectcomments.org/roadmap.
NIH expects to spend $30–50 million per year from within the currently
projected Roadmap budget for about 5 to 8 new 5-year (or in exceptional
cases up to 10-year) initiatives. Access information about the Roadmap
Initiative and projects that have been funded thus far on the Web
site. The
Request for Information appeared in the NIH Guide, NOT-OD-07-011.
Comment Sought on Data Sharing Policy for Genome-Wide Association
Studies, Town Meeting Set December 14, 2006
The deadline to submit comments on an NIH proposed policy for sharing
data obtained in genome-wide association studies (GWAS) supported or
conducted by the Institutes has been extended to November 30, 2006. In
addition, NIH will host a Town Hall Meeting about the policy on December
14 in the Bethesda, MD, vicinity. Check the GWAS
Web site for updates
on plans for the meeting.
A GWAS is defined as any study of genetic variation across the entire
human genome that is designed to identify genetic associations with observable
traits (such as blood pressure or weight), or the presence or absence
of a disease or condition.
The draft policy is proposed to apply to active research applications
identified by applicants or NIH staff as GWAS as explained in NIH
Guide Notice, NOT-OD-06-071.
Comments may be submitted through an online form, by e-mail to GWAS@nih.gov,
or by postal mail to NIH GWAS RFI Comments, National Institutes of Health,
Office of Extramural Research, 6705 Rockledge Drive, Room 350, Bethesda,
MD 20892-7963.
Please refer to the NIH Guide Notice to read:
- complete text of the Request for Information and access the online
comment form, NOT-OD-06-094;
- information about extension of the deadline to November 30, NOT-OD-07-012;
and
- information about the Town Hall Meeting, NOT-OD-07-013.
NIH Changes Standard Receipt Dates for Grant Applications
The standard receipt dates for grant applications submitted to NIH,
the Agency for Healthcare Research and Quality (AHRQ), and National Institute
for Occupational Safety and Health (NIOSH) change in January 2007 for
both paper and electronic applications.
Some key points are:
- The heaviest receipt dates from all agencies
on Grants.gov are
the first of the month, the 15th of the month, the first Friday, and
last day of the month. The new receipt dates have been intentionally
offset from these dates to improve Grants.gov response times
for NIH applicants.
- Effort was made to use recurring days of the
month for simplicity (i.e., new R01s would come in on February 5 and
renewals on March 5).
- The R01s, NIH’s most frequently used mechanism,
were kept early in the receipt window to allow time for processing. The
receipt date of the 5th of the month was chosen to be sure the bulk of
submissions that come in on the receipt date and the few days prior miss Grants.gov’s
heaviest volume days.
Applications for Request for Applications (RFAs) and Program Announcements
(PAs, PARs, PASs) with special receipt dates continue to be due on the
specified dates listed in the Funding Opportunity Announcements (FOA).
For an application to be considered on time, it must be received by Grants.gov by
5 p.m. local time of the applicant institution (NIH Guide NOT-OD-06-050).
The
changes are announced in the NIH Guide, NOT-OD-07-001.
| |
Receipt Cycle I |
Receipt Cycle II |
Receipt Cycle III |
Program Project Grants and Center Grants – all P Series
new, renewal, resubmission, revision* |
January 25
(old date Feb. 1) |
May 25
(old date June 1) |
September 25
(old date Oct. 1) |
Research Grants – R10, R18, R24, R25
new, renewal, resubmission, revision* |
January 25
(old date Feb 1, March 1) |
May 25
(old date June1, July 1) |
September 25
(old date Oct. 1, Nov. 1) |
Research-Related and Other Programs – all S and G Series, C06, M01
new, renewal, resubmission, revision* |
January 25
(old date Feb. 1) |
May 25
(old date June 1) |
September 25
(old date Oct. 1) |
Institutional Ruth L. Kirschstein National Research Service Awards - T Series (Training)**
new, renewal, resubmission, revision* |
January 25
(old date Jan. 10) |
May 25
(old date May 10) |
September 25
(old date Sept. 10) |
Research Grants - R01
new |
February 5
(old date Feb. 1) |
June 5
(old date June 1) |
October 5
(old date Oct. 1) |
Research Career Development – all K series
new |
Feb 12
(old date Feb. 1) |
June 12
(old date June 1) |
October 12
(old date Oct. 1) |
Research Grants - R03, R21, R33, R21/R33, R34, R36
new |
February 16
(old date Feb. 1) |
June 16
(old date June 1) |
October 16
(old date Oct. 1) |
Academic Research Enhancement Award (AREA) - R15
new, renewal, resubmission, revision* |
February 25
(no change) |
June 25
(no change) |
October 25
(no change) |
Research Grants - R01
renewal, resubmission, revision* |
March 5
(old date March 1) |
July 5
(old date July 1) |
November 5
(old date Nov. 1) |
Research Career Development – all K series
renewal, resubmission, revision* |
March 12
(Old date March 1) |
July 12
(old date July 1) |
November 12
(old date Nov. 1) |
Research Grants - R03, R21, R33, R21/R33, R34, R36
renewal, resubmission, revision* |
March 16
(old date March 1) |
July 16
(old date July 1) |
November 16
(Old date Nov. 1) |
New Investigator – R01
resubmission* for those applications involved in pilot ONLY (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-060.html) |
March 20
(no change) |
July 20
(no change) |
November 20
(no change) |
Small Business Innovation Research (SBIR), Small Business Technology Transfer (STTR) Grants - R43, R44, R41 and R42
new, renewal, resubmission, revision* |
April 5
(old date April 1) |
August 5
(old date Aug. 1) |
December 5
(old date Dec. 1) |
Individual Ruth L. Kirschstein National Research Service Awards (Standard) – all F series Fellowships.
new, renewal, resubmission* |
April 8
(old date April 5) |
August 8
(old date Aug. 5) |
December 8
(old date Dec. 5) |
Conference Grants and Conference Cooperative Agreements - R13, U13
new, renewal, resubmission, revision* |
April 12
(old date April 15) |
August 12
(old date Aug. 15) |
December 12
(old date Dec. 15) |
AIDS and AIDS-Related Grants
ALL of the mechanisms cited above
new, renewal, resubmission, revision* |
May 1
(no change) |
September 1
(no change) |
January 2
(no change) |
* The move to electronic applications also has brought a change in terminology. The new Grants.gov terminology (included in the table above) corresponds to traditional NIH terms as follows:
· New = new
· Resubmission = a revised or amended application
· Renewal = Competing Continuation
· Continuation = Noncompeting Progress Report
· Revision = Competing Supplement
** Institutional Research Training Grants (T32) are accepted by many NIH Institutes and Centers (IC) for only one or two of the dates. Applicants should contact the relevant IC for specific dates.
At present, NIH receives and processes applications for NIOSH and for
components of Centers for Disease Control and Prevention (CDC) that participate
in the Omnibus Solicitation for Small Business Innovation Research grant
applications. The application deadlines above apply only to these two
groups of applications and not to other CDC submissions.
Training Offered on Electronic Grant Application Submission, Online
and at NIH Dec. 4-6, 2006
Upcoming Transition Dates
| |
Type of Grant |
Deadline for Non-AIDS |
Deadline for AIDS |
| Research Project Grant |
R01, U01 |
February 5, 2007 |
May 1, 2007 |
| Career Development |
K |
June 12, 2007 |
|
| Fellowships |
F |
August 8, 2007 |
September 1, 2007 |
| Centers, Research Program Projects |
P01, P50 |
September 25, 2007 |
January 2, 2008 |
See full list at: era.nih.gov/ElectronicReceipt/strategy_timeline.htm  *
transitions to come in 2007-8
Revised schedule as of April 2006
NIH is hosting presentations on the new process for submitting grant
applications electronically with the SF424 Research and Related (R&R)
application and “hands on” computer lab sessions December
4-6, 2006, on the NIH Campus, Bethesda, MD. Two plenary sessions
will be held on Tuesday, December 5, at the Natcher Conference Center
that also will be videocast for remote viewing. The sessions are
from 9 a.m.–Noon EST and repeated (live & videocast)
from 1:00 p.m.– 4:00 p.m. EST. A presentation also will
be archived for later viewing at videocast.nih.gov. Register for
the presentations and/or lab sessions at era.nih.gov/training/esub_120506.
The 3 ½ hour
computer labs also will be on the NIH Campus. Registrants who are unable
to attend the plenary presentation should view the video “Interacting
Electronically with NIH” prior to attending a lab.
The
Research Project Grant—the R01—is the next grant mechanism
slated for transition to use of the SF424 (R&R) application forms
and electronic submission via Grants.gov. Investigators who
are preparing to submit research proposals for the February 1, 2007,
deadline for non-AIDS research proposals are required to apply electronically.
The transition from paper to electronic submission has been occurring
by type of mechanism. Many mechanisms have already transitioned, including
the Small Grants Program (R03), Exploratory/Developmental Research Grants
(R21), and the Small Business Innovation Research (SBIR) and Small Business
Technology Transfer Research (STTR) Programs (R41, R42, R43, R44) mechanisms.
This move to electronic submission of applications is part of a Federal
government-wide initiative to simplify financial assistance application
requirements and create a single Web site through which to identify and
apply for grant opportunities. Be aware that there is a 2-step
requirement to first preregister with the NIH eRA Commons and secondly
with Grants.gov before submitting an SF424. Completing the separate
registration processes for eRA Commons and Grants.gov can take
several weeks. NIH recommends starting the registration process now or
at a minimum 2–4 weeks ahead of your target submission date.
We cannot emphasize enough the importance of preparing for the transition.
See the box above for a partial list of upcoming transition dates. Applications
submitted in advance for a receipt date designated as a transition deadline
must use the new SF424 forms.
Other helpful Web sites:
Advance Notice of 8 Weeks a MUST to Submit Large-Budget Cancer
Epidemiology Applications!
NIH requires grant applicants with a requested budget of $500,000 or
more in direct costs in any year to contact the appropriate program staff
member before submitting applications to the NIH Center for Scientific
Review (CSR) for peer review. The Notice in the NIH Guide states
that approval must be sought 6 weeks prior to submitting the grant. However,
approval for NCI epidemiology applications must be sought at least 8
weeks prior to submission to CSR to complete the internal processing
by the deadline.
Investigators must follow this policy, speak to the appropriate
Program Director, and respond to requests for information.
If advance notice about the proposed study and budget is not received,
applications will be returned, causing a delay in submission and review
of one round. This policy applies to new, competing continuation, competing
supplement, and amended/revised applications. The policy does not apply
to applications submitted in response to RFAs or in response to other
announcements that include specific budgetary limits.
See the NIH Guide, NOT-OD-02-004 and
NOT-CA-02-029.
Multiple Principal Investigator Option on Grants Expanded
The option of having more than one principal investigator on individual
research awards will become a reality for many types of grant applications
that are electronically submitted beginning with the February 2007 receipt
dates. The option will include applications for Research Project Grants
(R01), Small Research Grants (R03), Exploratory/Development Grants (R21),
and others. Watch for an announcement with more specifics to appear soon
in the NIH Guide.
The aim of the Multiple Principal Investigator option is to encourage
multidisciplinary and other types of “team science” projects
that are not optimally served by the single-principal investigator model.
Projects suitable for the Multiple-Principal Investigator option could
include as few as two principal investigators who are jointly responsible
for the scientific and technical direction of the project. NIH has been
pilot testing the option over the past 6 months with various Funding
Opportunity Announcements (FOA). Further information is available on
NIH’s Multiple
Investigators Web page. Direct
questions to multi_PI@mail.nih.gov.
Data-Sharing Information Resources Available
NIH’s Office of Extramural Research (OER) has a Web page that
provides access to various information resources on data sharing. Investigators
who submit NIH grant, cooperative agreement, or contract proposals seeking
$500,000 or more in direct costs in any single year are expected to include
a plan for data sharing or state why data sharing is not possible. Access
the Data Sharing
Web site.
EGRP-Supported Research Resources
EGRP invites researchers to take advantage of its research resources:
Long Island Breast Cancer GIS Available for Use, Custom Extensions
Offered
 The Geographic Information System for Breast Cancer Studies on Long
Island (LI GIS) is an enterprise geographic information system combining
an Oracle data warehouse, ESRI ArcGIS Suite, and statistical and spatial
software and extensions. The LI GIS is designed to study potential relationships
between environmental exposures and breast cancer on Long Island (Suffolk
and Nassau counties) and is available to researchers with approved protocols.
It also can be used to study other diseases.
This unique research tool offers a full suite of GIS software and extensions
related to the study of breast cancer. Included are four custom ArcGIS
software extensions specially developed for LI GIS users but also freely
available for researchers to download from the Web site and use for applications
beyond Long Island. The extensions are tools for cluster analysis and
applying the Empirical Bayes method, a disease rate calculator, and an
areal interpolator. They are available for ArcView versions 3.x, 8, and
9.
The LI GIS warehouse has more than 80 datasets covering topographic
data; demographic data; health outcome data, including relative breast
cancer incidence; and environmental data for Long Island. Additional
environmental data are included with less detail and geographic precision
for areas 50 kilometers from the two counties, and very limited data
for areas within a 100-mile radius from the midpoint of the boundary
line between the two counties. The extended area includes counties in
Connecticut, New Jersey, New York, Pennsylvania, Rhode Island, and Massachusetts.
Researchers can access the LI GIS remotely or work in its laboratory
located in Reston, VA. There is no fee to use the LI GIS or its laboratory;
however, funding for research is not provided.
The LI GIS was developed as part of the Long Island
Breast Cancer Study Project (LIBCSP).
Contact: Shannon Lynch, M.P.H., Co-Project Officer;
e-mail: lynchs@mail.nih.gov.
Breast and Colon Cancer Family Registries
 The Breast and Colon Cancer Family Registries (CFRs) are international
registries available to researchers who are planning to conduct population-
and clinic-based interdisciplinary research with a main focus on the
genetic and molecular epidemiology of breast and colon cancers. The CFRs
have information and biospecimens contributed by more than 23,300 families
among whom there is a history of breast or colon cancer. The spectrum
of cancer risk is represented.
Of special interest are collaborations to identify and characterize
cancer susceptibility genes; define gene-gene and gene-environment interactions
in cancer etiology; and conduct cooperative research on the translational,
preventive, and behavioral aspects of such findings. Researchers who
are interested in accessing data and/or biospecimens can learn more about
the CFRs and the application process at the Web site. The
Web site has much information for potential collaborators and the public.
The CFRs do not provide funding for research.
Contact: Daniela Seminara, Ph.D., M.P.H., Program Director;
e-mail: seminard@mail.nih.gov.
Cancer Genetics Network
The Cancer Genetics Network (CGN) supports research on the genetic basis
of human cancer susceptibility, the integration of this information into
medical practice, and the psychosocial, legal, and public health issues
associated with human genetics. Its interests include gene discovery
and characterization, gene-environment interaction, and translational
and behavioral research.
The database has information on 26,000 individuals (16,000 families)
with cancer and/or a family history of cancer. Data available include
demographic information, relevant medical history, and a four-generation
pedigree on each enrollee. The population enrolled makes research possible
on both common and uncommon tumors.
For approved studies, the CGN can offer a variety of services for a
fee(s), including: assembling information for and completing medical
extraction forms; obtaining pathology reports and tumor blocks for molecular
testing or to verify diagnosis; collecting biospecimens, including fresh
tissue, with desired medical and demographic information; shipping or
storing biospecimens; recruiting patients from high-risk clinics and
tumor registries; conducting telephone interviews with enrollees; providing
genetic counseling; contacting enrollees’ treating physicians prior
to enrollment; developing software, including computerized followup for
the study; and using multiple software systems for breast cancer risk
assessment.
Specialized expertise is available in certain areas, including biostatistics,
statistical genetics, epidemiology, genetic epidemiology, and behavioral
research. Also, CGN principal investigators welcome opportunities to
collaborate with research groups on important studies.
Researchers interested in accessing CGN data or including registry enrollees
in ongoing or proposed studies should prepare a 1-page summary of their
proposed research, specific aims, and explanation of the role of CGN
enrollees in the research. Priority is given to funded investigators
or to those who are planning to submit grant proposals to NIH. Funding
for research is not provided. For further information, access
the Web site.
Contact: Carol Kasten, M.D., Program Director; e-mail: kastenca@mail.nih.gov.
New Publications
The Nation’s Investment in Cancer Research: A Plan and Budget
Proposal for Fiscal Year 2008
 This
publication describes NCI’s strategies and plans to decrease the burden of cancer.
It highlights scientific accomplishments and opportunities, from broad
analyses of research trends to examples of targeted projects, and trends
affecting current and future research, progress on NCI objectives,
a description of NCI’s infrastructure for implementing its objectives,
and a proposed budget for Fiscal Year 2008. The annual document has
been called the “Bypass Budget” because NCI submits its
budget request directly to the President for review and transmittal
to Congress. This report is available
online.
Print copies can be ordered from NCI’s
Publications Locator.
Geographic Information Systems (GIS) and Cancer Research
 This
publication provides information about how GIS can be used in cancer
research, including to gain information about environmental exposures,
monitor emerging trends for cancer control, look at health disparities,
conduct research on behaviors, and provide the basis for health policy.
It describes applications for GIS technology in various areas of cancer
research, describes GIS tools and resources, landmark GIS studies, and
current funding opportunities in GIS with NCI’s Division of Cancer
Control and Population Sciences (DCCPS). The document is expected to
be available in December via NCI’s Publications Locator.
NCI Cancer Bulletin
 New
each week, NCI’s online
newsletter provides information about Institute programs and initiatives.
Regular features include the NCI Director’s update, information
on funding opportunities, research highlights, legislative updates, interviews
with important people in cancer research, and a calendar of meetings
and presentations. Access the Bulletin and
subscribe.
Cancer Epidemiology and Prevention
 The third edition of Cancer Epidemiology and Prevention,
edited by David Schottenfeld, M.D., and Joseph M. Fraumeni, Jr., M.D.,
has been published by Oxford University Press. Many of the authors are
current or former EGRP grantees and NCI scientists. The book provides
a comprehensive presentation of the global burden and patterns of cancer
occurrence, along with new developments in our understanding of cancer
causation and prevention. Special attention is given to epidemiologic
approaches that incorporate molecular biomarkers based on genomic and
other emerging technologies, providing new insights into the role of
genetic predisposition and gene-environment interactions in cancer induction.
New chapters are included on social class disparities in cancer incidence
and mortality, the role of obesity and physical inactivity in cancer
etiology, the potential effects of electromagnetic fields and radiofrequency
radiation, and principles of cancer chemoprevention.
Deborah (Debbie) Winn, Ph.D., EGRP Acting Associate Director, is a
co-author of the chapter “Cancers of the Oral Cavity and Pharynx.” Other
NCI authors are from our Division of Cancer Control and Population Sciences
(DCCPS), Division of Cancer Epidemiology and Genetics (DCEG), and Division
of Cancer Prevention (DCP).
Sources of Information on Grant Policies, Funding, and Training
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