and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Cancer Institute (NCI) |
|
Funding Opportunity Title |
Biomarkers of Infection-Associated Cancers (R21) |
Activity Code |
R21 Exploratory/Developmental Research Grant Award |
Announcement Type |
Reissue of PA-08-157 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PA-11-159 |
Companion FOA |
|
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.393, 93.394, 93.396, 93.121 |
FOA Purpose |
This funding opportunity announcement (FOA), issued by the National Cancer Institute (NCI) and the National Institute of Dental and Craniofacial Research (NIDCR), of the National Institutes of Health (NIH), encourages the submission of Exploratory/Developmental Research Grant Award (R21) applications from institutions and organizations that propose to identify biomarkers for cancers where the etiology of the disease is attributed to infectious agents. |
Posted Date |
March 17, 2011 |
Open Date (Earliest Submission Date) |
May 16, 2011 |
Letter of Intent Due Date |
Not Applicable |
Application Due Date(s) |
Standard dates apply, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date(s) |
Standard dates apply |
Expiration Date |
May 8, 2014 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This funding opportunity announcement (FOA), issued by the National Cancer Institute (NCI) and the National Institute of Dental and Craniofacial Research (NIDCR), of the National Institutes of Health (NIH), encourages the submission of Exploratory/Developmental Research Grant Award (R21) applications from institutions and organizations that propose to identify biomarkers for cancers where the etiology of the disease is attributed to infectious agents.
Infection-associated cancers are increasing at an alarming rate. Approximately 15 percent of cancers (about 1.5 million cases per year, worldwide) are linked to viral (11 percent), bacterial (4 percent), and other pathogens (0.1 percent), and the prevalence of these infectious agents is rising. Although the number of people infected is very high, only a minor proportion ever develops cancer. Furthermore, etiologic links between newly identified infectious agents, such as the xenotropic murine leukemia virus-related virus (XMRV) and cancer, have recently been suggest but remain to be firmly established. The objective of this FOA is to foster research to increase our knowledge of infectious agent-associated malignancies and identify those who are at increased risk of developing cancer among infected individuals and to detect early stage cancers in this population.
In many cases, the infectious agents are widely present in humans, but only a small fraction of infected individuals develop cancer. For example, 10 million women in the U.S. have cervical human papillomavirus infections, but only 15 thousand develop cancers. In addition, only 1 percent of Helicobacter pylori-infected persons will develop gastric cancer. Thus, it is important to identify subpopulations of exposed individuals who are likely to develop cancer and to develop sensitive and specific screening tools to monitor for early stage cancers in infected populations. Identifying these subpopulations has proven difficult. Molecular markers provide a potential tool to identify the at-risk subpopulation and the presence of early stage cancers. These molecular markers must therefore be able to distinguish ordinary infections per se from infections that contribute to the development of cancer.
Cancer-associated infectious agents likely act, at least in part, by predisposing the cell to oncogenic changes that contribute to the progressive steps leading to cancer. It is very likely that these processes lead to a microenvironment conducive to cellular transformation resulting in the development of cancer. Thus, it is important to identify molecular changes that occur during the progression to cancer in infected cells and the tumor microenvironment. It is likely that distinguishing cells destined to become cancerous from all infected cells will require the identification of differential expression patterns of multiple molecular markers, i.e., generating molecular signatures that are specific for risk of developing cancer. These molecular signatures must permit reliable and accurate identification of at-risk individuals at a stage early enough to allow for effective intervention. Molecular profiles may be used to identify lesions associated with a high risk of developing cancer to help distinguish high-risk populations. Molecular analyses will also provide valuable insights into the mechanisms by which infectious agents promote cancer and may help identify potential targets for early detection and cancer prevention.
Humans are colonized by complex microbial communities, or microbiomes, which are thought to play an important role in human physiology. It is now appreciated that microbial community structure or composition contributes to health or disease. Recently, changes in the composition or diversity of microbial communities (dysbiosis) have been reported to be associated with numerous diseases including cancer. In one recent study, the esophageal microbiome of patients with gastroesophageal reflux disease (GERD), including Barrett’s esophagus (a precursor lesion for developing esophageal adenocarcinoma), was shown to be distinct from that of healthy controls. Thus, in addition to specific bacteria or viruses, abnormal microbial communities can also be considered pathogenic. The development of high-throughput sequencing technologies and bioinformatic infrastructure, supported in part by Human Microbiome Project (HMP), has revolutionized the sampling, identification, and analysis of the human microbiome. Outstanding questions in microbiome research are whether particular body sites (in particular, gastrointestinal, skin, urogenital, and oral cavity) are associated with a core healthy microbiome, whether core microbiomes are stable across body sites and across time, how microbiome structure changes in health and disease, whether changes in microbiome structure directly drive the disease process or are only indicators of an altered/distressed tissue, and the relationship between host genotype and microbiome composition. Microbiome-focused studies are leading new research efforts in basic and applied research to develop innovative strategies for the diagnosis, prevention, and treatment of human disease and cancer.
There are relatively few reports on precancer molecular markers of infected hosts. With the advent of high-throughput molecular profiling technologies (e.g., gene microarrays, antibody arrays, and peptide mapping using mass spectrometry), it has become easier to identify molecular signatures of infected host cells and to perform correlative studies in the attempt to identify high-risk populations in an efficient and timely fashion. Proposed studies should apply these technologies or others so that disease-specific markers and/or profiles can be recognized and used to identify infected individuals in whom infected cells are progressing into cancer to distinguish high-risk populations.
The long-term goal of this FOA is to encourage research that will increase our knowledge of infectious agent-associated malignancies and utilization of molecular profiles in early detection, risk assessment, and prevention of cancer. For example, infections with Hepatitis C and B viruses are major risk factors for hepatocellular cancer, but most infected individuals do not develop cancer. If detected early, the 5-year survival rate for hepatocellular carcinoma following liver transplant is greater than 80 percent. However, most hepatocellular cancers are detected at late stages when there are few effective treatment options. Human papilloma virus (HPV) is responsible for as many as 100,000 cases of head and neck squamous cell carcinomas worldwide per year, the majority of which are oropharyngeal and tonsillar cancers. In the United States (U.S.), prevalence estimates of oral HPV infection ranges from 9.2 to 18.6 percent. The incidence of tonsillar cancer in the U.S. has increased by 2 to 3 percent per year from 1973 to 1995. HIV-infected individuals have a 2- to 6-fold increase in risk of developing oropharyngeal and tonsillar cancers. Nasopharyngeal carcinoma (NPC) is a malignant neoplasm of the nasopharynx that is associated with Epstein-Barr Virus (EBV) infection. NPC is rare in most parts of the world, but it is an important health problem in China and Southeastern Asia.
Molecular signatures that either distinguish individuals with infectious agents who are at high risk of developing cancer or detect early stages of cancer in infected individuals would result in early detection and reduced mortality. These molecular approaches provide snapshots of how infectious agents promote cellular transformation through altered biology of the infected cells and their interactions with the host environment. The NCI recognizes signatures of cancer cells, gene-environment interactions, and tumor microenvironments as high priority areas.
This initiative encourages research to identify molecular markers for risk assessment and early detection in individuals exposed to infectious agents that have been linked to cancer. Listed below, but not limited to, are several programmatic areas in need of support for developing molecular signatures for infectious agent-associated cancers.
I. Molecular profiles of normal, precancerous, and cancerous lesions following infection and of body fluids from infected individuals: Infectious agents interact with host cells and activate sets of infectious agent-specific and host-specific genes and proteins. Often some of these proteins are secreted into extracellular fluids. Samples utilized for studies may be derived from tissues or body fluids (e.g., serum, nipple aspirate, pancreatic juice, sputum, urine, alveolar lavage, saliva, stool). It is advantageous if marker profiles can be obtained from body fluids that are collected using minimally invasive methodologies. In addition, chronic inflammation in response to the infectious agent may play a role in cancer development. It may be possible that indicators of inflammation or immune activation could also be useful indices of cancer predisposition.
II. Evaluation of these molecular profiles for use in gaining a better understanding of the role of infectious agents in cancer development and use in early detection, risk assessment, and prevention of cancer: In all known cases, infectious agents that are associated with cancers persist for long periods in the host before cancer develops. How the host responds to the infectious agents and how the agent modulates this response are critical in allowing for its persistence and may determine the risk of cancer. Molecular profiles should be analyzed to determine whether a single biomarker, panel of biomarkers, or molecular patterns can be used to determine which infected individuals are at risk of developing cancer and to determine the transition from chronic infection to the initiation of cancer. These molecular profiles may also be used to identify targets for cancer prevention and therapeutic vaccine development.
Research projects proposed in the applications may involve a number of infectious agents showing associations with cancer. Noteworthy viral agents of interest to this program are human papillomavirus (HPV), Hepatitis B and C viruses, Epstein-Barr virus (EBV), xenotropic murine leukemia virus-related virus (XMRV), and Simian Virus 40 and Merkle cell polyomaviruses. Furthermore, an escalating prevalence of early cervical, lung, and colon cancers has emerged among HIV patients. Applicants are also invited to investigate bacterial etiology in cancer, such as the role of Helicobacter pylori in the development of gastric cancers. In addition, studies aimed at investigating associations between altered microbiome composition and cancer to establish microbiome signatures as biomarkers for cancer or as mechanistic bases for cancer development and progression are encouraged. The involvement of parasitic infections in various cancers is also relevant to this FOA. The National Institute of Dental and Craniofacial Research (NIDCR) has particular interest in EBV- and HPV-associated head and neck cancers, including oral and oropharyngeal cancers in both HIV-1-infected and non-HIV-1-infected populations. NIDCR also supports infectious-associated tumors (benign and malignant) of the salivary glands. Research projects covering basic science (infectious life cycle, viral replication, etc.) or treatment studies of these infectious agents without direct relevance to cancer biomarker development are not encouraged by this FOA.
Funding Instrument |
Grant |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Award Budget |
Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. |
Award Project Period |
The total project period for an application submitted in response to this funding opportunity may not exceed two years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions:
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For profit Organizations
Governments
Other
Foreign (non-U.S.) components of U.S. Organizations are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Project Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD/PIs must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review , NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants Policy
Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Grants.gov
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submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
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process, finding NIH grant resources)
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Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Karl Krueger, Ph.D.
Division of Cancer Prevention (DCP)
National Cancer Institute (NCI)
6130 Executive Boulevard, EPN Room 3147, MSC 7362
Bethesda, MD 20892-7362 (for U.S. Postal Service express or
regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 435-1594
Email: [email protected]
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Division of Cancer Biology (DCB)
National Cancer Institute (NCI)
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Bethesda, MD 20892- 7388 for U.S. Postal Service express or
regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-7815
Email: [email protected]
Sundar Venkatachalam, Ph.D.
Director, Epithelial Cell Regulation and Transformation Program
Division of Extramural Research
National Institute of Dental and Craniofacial Research (NIDCR)
National Institutes of Health (NIH)
6701 Democracy Blvd., Room 625
Bethesda, MD 20892-4878
Phone: 301-594-4812 Fax: 301-480-8319
Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Amy Bucheimer
Office of Grants Administration
National Cancer Institute (NCI)
6120 Executive Boulevard, EPS Suite 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 846-1014
Email: [email protected]
Mary Daley Greenwood
Chief, Grants Management Branch
National Institute of Dental and Craniofacial Research (NIDCR)
Democracy I, Room 658
6701 Democracy Boulevard
Bethesda, MD 20892-4878
Telephone: (301) 594-4808
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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