Part I Overview Info
Department of Health and Human Solutions
Participating Organizations
National Cancer Institute (NCI), (
Title: Validation and Advanced Advancement of Emerging Technologies in Biospecimen Science (R33)
Announcement Sort
This Funding Opportunity Announcement (FOA) can be a reissue of RFA-CA-09-005.
Update: The following update referring to this announcement continues to be issued:
August sixteen, 2010 - Essential Observe! NIH has eradicated the error correction window for because of dates of January 25, 2011 and past. As of January 25, all corrections should be comprehensive by the due date for an software to become thought to be on-time. See NOT-OD-10-123. February 19, 2010 - See Recognize NOT-CA-10-018 The purpose of this Observe is always to clarify the Finances Kind . January 6, 2010 - This FOA has long been updated to mirror the brand new specifications from NIH’s Enhancing Peer Review Initiative. The brand new needs are powerful for submissions meant for because of dates January twenty five, 2010 and beyond. If submitting an software meant for any due date of January 25, 2010 and past, follow the guidance beneath and make sure to work with the Adobe-Forms-B edition of your application types and recommendations. If applying for a because of date just before January twenty five, 2010, comply with the advice from the archived edition of this FOA and be certain to make use of the Adobe-Forms-A version of your software types and directions. October 26, 2009 - See Observe NOT-CA-10-005 Variety of Proper Funding Opportunity Announcements (FOAs) for your Continuation of your Revolutionary Technologies for Molecular Analysis of Cancer (IMAT) Program .
Request for Programs (RFA) Number: RFA-CA-10-002
NOTICE: Programs submitted in response to this Funding Possibility Announcement (FOA) for Federal help has to be submitted electronically through Grants.gov ( utilizing the SF424 Analysis and Connected (R&R) forms and the SF424 (R&R) Software Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA have to be read in conjunction with the software guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary ahead of submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Help Amount(s)
93.393, 93.394, 93.395, 93.396
Key Dates
Release/Posted Date: October 26, 2009
Opening Date: January 23, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 23, 2010; April 27, 2010; August 30, 2010
NOTE: On-time submission requires that apps be successfully submitted to Grants.gov no later than 5:00 p.m. local time (from the applicant institution/organization)
Application Because of Date(s): February 23, 2010; May 27, 2010; September 30, 2010
Peer Critique Date(s): May/June 2010; August/September 2010; January/February 2011
Council Critique Date(s): October 2010; January 2011; May 2011
Earliest Anticipated Start Date(s): December 2010; April 2011; July 2011
Additional Data To get Available Date (Activation Date): Not Applicable
Expiration Date: October 1, 2010
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Function. This Funding Option Announcement (FOA), issued by the National Cancer Institute (NCI), Nationwide Institutes of Wellbeing (NIH), solicits grant programs proposing technically modern feasibility studies focused on the innovative advancement and validation of cancer-relevant technologies that address the issues connected to pre-analytical variations inside the collection, processing, handling, and storage of biospecimens or its derivatives. The overall goal is to develop technologies capable of interrogating and/or maximizing the quality and utility of biospecimens or their derived samples for downstream molecular analyses. This FOA will support the growth of tools, devices, instrumentation, and associated methods to assess sample quality, preserve/protect sample integrity, and establish verification criteria for quality assessment/quality control and handling under diverse conditions. This FOA solicits R33 apps; this mechanism is suitable for projects where proof-of-principle of your proposed technology or methodology has already been established and supportive preliminary data are available. Projects proposing to use established technologies where the novelty resides within the biological or clinical question being pursued is an example of a topic not acceptable for this solicitation and will be returned as non-responsive. This funding possibility is component of a broader NCI-sponsored Innovative Molecular Evaluation Technologies (IMAT) Plan. Mechanism of Support. This FOA will utilize the R33 grant mechanism and runs in parallel with a FOA of identical scientific scope, RFA-CA-10-001 that solicits apps under the NIH Exploratory/Developmental R21 grant mechanism. Funds Available and Anticipated Range of Awards. The NCI intends to commit a total of approximately $2,250,000 in fiscal year 2010 to award up to 7 grants in response to this FOA. Price range and Project Period. An applicant for an R33 grant may request a project period of up to 3 years with a spending budget appropriate to the science proposed. Direct costs cannot exceed $300,000 for any given year. Software Study Strategy Length: The R33 application Analysis Strategy section with the PHS398 may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply. Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed analysis are invited to work with their institution/ organization to develop an software for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Amount of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application. Number of Purposes. Applicants may submit more than one software, provided each software is scientifically distinct. Resubmissions. Applicants may submit a resubmission application, but such software need to include an Introduction addressing the previous peer critique critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Renewals. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) purposes will not be accepted. Special Date(s). This FOA uses non-standard due dates. See Receipt, Critique and Anticipated Start Dates. Software Materials. See Section IV.1 for software materials. All apps, including resubmission, revision and renewal, submitted for due dates January twenty five, 2010 and outside of, must utilize the most current kinds and instructions. General Info. For general information on SF424 (R&R) Software and Electronic Submission, see these Web sites: SF424 (R&R) Software and Electronic Submission Details: General data on Electronic Submission of Grant Programs: Hearing Impaired. Telecommunications for that hearing impaired are available at: TTY: (301) 451-5936
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Possibility Description
1. Investigation Objectives
Section II. Award Data
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Data
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Software and Submission Info
1. Request Application Details
2. Content and Type of Application Submission
3. Submission Dates and Times
A. Receipt, Critique, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Software Electronically to the NIH
C. Software Processing
4. Intergovernmental Critique
5. Funding Restrictions
6. Other Submission Needs
Section V. Application Review Information
1. Criteria
2. Assessment and Choice Process
A. Additional Critique Criteria
B. Additional Evaluation Considerations
C. Resource Sharing Plan
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Data
1. Award Notices
2. Administrative and Nationwide Policy Requirements
3. Reporting
Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Evaluation Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Data - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Possibility Description
1. Research Objectives
Purpose
This Funding Option Announcement (FOA) solicits grant apps proposing research projects focused on the advanced advancement and validation of innovative transformative cancer-relevant technologies aimed at maximizing the quality and utility of samples and/or biospecimens used for biomedical research and medicine. The thrust of effort from the projects proposed in response to this FOA should be on the superior development of a technology, rather than on its initial inception and pilot stage development. In this FOA, the National Cancer Institute (NCI) solicits grant applications proposing study projects focused on the growth of novel emerging technologies addressing various aspects of your collection, preparation, processing, storage, and handling of cancer-relevant biospecimens and/or its derivatives. The emphasis of this FOA is on the validation of technologies with a high degree of technical innovation and potential to significantly impact and transform study into cancer biology, treatment and diagnosis, prevention, control and epidemiology, and/or cancer wellness disparities. Applicants are referred to the NCI Office of Biorepositories and Biospecimen Science (OBBR, for any better understanding from the current technology needs in the biospecimen sciences. Technologies of interest to this FOA could conceivably be used to support the various NCI biospecimen initiatives,
Office Professional 2007, such as the Cooperative Human Tissue Network (CHTN, and the Minority Biospecimen/Biobanking efforts planned from the NCI Center to Reduce Cancer Health Disparities (
Investigators interested in developing progressive and/or emerging cancer technologies that are not relevant to the biospecimen sciences should consider applying to relevant FOAs that are part of a broader NCI-sponsored Revolutionary Molecular Evaluation Technologies (IMAT, Plan.
This FOA utilizes the R33 award mechanism for projects proposing the sophisticated growth of an rising technology. The R33 mechanism is suitable for technology projects that are at the latter stages of growth, where technical feasibility continues to be demonstrated but lack validation within context of its intended use or proposed application. Feasibility (proof-of-concept) data are required for this FOA.
The IMAT Program
Since its inception in 1998, the IMAT Program ( has focused on stimulating and accelerating the growth, integration, maturation, and dissemination of your most novel and highly progressive technologies in support of cancer research and medicine. Together with the NCIs other technology intensive programs, IMAT continues to generate the tools and methods that enable cancer researchers to make new discoveries, enhance the knowledge-base, generate new and improved detection, develop diagnostic methods and treatment strategies, conduct large population studies, and assist in clinical decision making.
The IMAT System consists of your following three relevant themes:
1. Modern Technology Improvement for Cancer Investigation (RFA-CA-10-005), which emphasizes technology improvement projects that are centered on the inception and preliminary development of very early stage, highly innovative, high impact technologies for cancer study;
2. Rising Technology Advancement for Cancer Investigation (RFA-CA-10-003, RFA-CA-10-004), which supports investigation projects on the initial application or use of emerging, transformative technologies in a biological context relevant to the supposed use with the technology; and
3. Progressive and Applied Emerging Technologies in Biospecimen Science (RFA-CA-10-001, RFA-CA-10-002), which is centered on the growth and validation of novel technologies to assess, evaluate, and interrogate biospecimens, or analytes thereof, in order to maximize their quality and utility in cancer investigation.
For more details about the IMAT program, a summary with the suite of FOAs, and links to those FOAs, prospective applicants should consult the IMAT website:
Specific Investigation Objectives and Scope of this FOA
The main emphasis of this FOA is on the validation and superior development of a novel technology to advance the biospecimen sciences, rather than the initial technical improvement and inception. Projects proposed in response to this FOA must be pertinent to its overarching objective,
Office 2007 Product Key, i.e., applicants must address the advancement of technologies and methodologies that maximize the quality and utility of biospecimens and/or derived samples for cancer investigation and medicine. Projects proposed should be revolutionary rather than evolutionary; the conceived technologies should have the potential to dramatically alter the way that analysis can be pursued.
Responsive technologies encompass relevant techniques, tools, instrumentation, devices,
Windows 7 Home Premium, and associated methods. For example, tissue samples have a complex composition due to mixed normal and diseased cell populations. The direct application of currently available molecular techniques to tissue biospecimens can be extremely challenging as clinically derived samples typically offer limited amounts of material that can be used for analysis, and techniques used for procuring these samples add to the complexity. The yield of extracted biomolecules can further decrease if a microdissection-based approach is employed to procure a specific cell population, with questionable quality because of to processing steps such as fixation and embedding. Therefore, another focus of this FOA is on the innovative improvement of novel technologies that can overcome these challenges when directly implemented on the evaluation of biospecimens. Proposed projects need to develop and/or utilize novel cancer-related biospecimen/sample preparation, extraction, or transport methodologies/technologies to ensure appropriate, consistent, and well-controlled sample quality that is necessary in analysis and/or for clinical use. The development and/or utilization of methods and/or technologies to assess the qualities of biospecimens or samples are also suitable to this FOA.
These technologies may be meant for molecular and cellular analyses in-vitro, in-situ, in-silico and/or in-vivo (with some exceptions), and may be targeted for that needs of basic, translational, epidemiology, clinical cancer analysis and/or aim to reduce cancer-related health disparities within the biospecimen/sample preparation context. Responsive technologies should advance the biospecimen sciences and/or sample preparation methodologies. Projects focused on the development of biomarkers, drugs or other agents, or contrast agents are not responsive to this FOA. Projects focused on the application of technologies that will ultimately, if the technology is feasible, enable drug developers, biomarker researchers, and epidemiologists to pursue their work, are responsive.
It is expected that all apps proposing to develop new technologies for cancer biospecimen preparations adhere to the guidelines outlined within the NCI Best Practices for Biospecimen Resources, which can be found at
Applicants responding to this FOA need to meet the following general requirements (for details see Section IV.six. Other Submission Needs and Data; Additional Application Guidelines):
The application is focused on the validation and innovative development of an modern technology and has demonstrated limited feasibility, which may or may not be in context of its intended use or software. The proposed technology may be targeted for that biospecimen/sample preparation needs of basic, preventative, diagnostic, translational, epidemiology, and/or clinical cancer research or for broad potential use in cancer research. All proposed programs, must offer the potential for substantial improvements over conventional approaches and/or add qualitatively new investigation capabilities not provided by current technologies. The software should clearly define the novelty with the proposed technology and describe its anticipated use in a analysis laboratory and/or a clinical setting.
The following aspects/characteristics remain outside the scope of IMAT and this FOA. Programs proposing any of the following will be returned to the applicant as non-responsive without critique.
Projects focused on the elucidation of the effects of pre-analytical variations in biospecimen collection, processing, handling, or storage; Projects focused on a biological or clinical hypothesis (i.e. traditional biological-hypothesis driven investigation); Projects that propose to work with existing (off the shelf) technologies without substantial new growth and projects which propose only incremental technical advances to existing technologies; Projects focused primarily on software/informatics solutions, database advancement, data mining, statistical tools, and computational/mathematical modeling (including those applicable to drug and/or patient responses) with the exception of proposals which include software development embedded in new devices or small amounts of computational assessment as needed to develop new devices or methods; Technologies for whole-body or in vivo imaging methods; Projects involving clinical trials or toxicology studies; Projects focused on biomarker discovery or biomarker validation; Projects focused on growth of specific contrast agents; Projects focused on growth of specific drugs or therapies.
Researchers focusing on hypothesis-based biospecimen research should consider one with the opportunities from the NCI Office of Biorepositories and Biospecimen Analysis (
Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software solutions should consider one from the Biomedical Data Science and Technology Initiative (BISTI, opportunities.
Researchers who emphasize the assessment of whole body or in vivo imaging technologies as the primary focus of their project should contact the Cancer Imaging System (CIP, for information on acceptable funding opportunities.
Related IMAT FOAs: Applicants considering projects focused on progressive technologies that are in its earliest stages of growth or inception should consider connected IMAT FOA RFA-CA-10-001. Applicants considering projects on emerging technologies whose meant use does not address biospecimen/sample quality should consider associated IMAT FOAs RFA-CA-10-003 and RFA-CA-10-004.
Researchers who are unclear as to which of your IMAT FOAs might be most appropriate for their proposed technology advancement project are encouraged to contact the program official listed in this FOA.
Attributes of the NIH R33 Mechanisms from the IMAT context. The R33 mechanism is supposed to support the advanced stages of technology growth for those projects in which feasibility has been demonstrated, but not in context of its meant use or application. Proposed projects are expected to get novel and may involve considerable risk, but may lead to a breakthrough in a particular area that could have a major impact on cancer study. To become comprehensive and responsive to IMATs R33 FOAs, all purposes must include feasibility (proof-of-concept) data by means of prior research, which may or may not have been previously supported by an exploratory R21 grant.
The R33 project is expected to generate sufficient data to fully validate the technology in a biologically relevant setting and demonstrate its full utility in addressing the biospecimen sciences or sample preparation methodologies.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This FOA will use the NIH R33 (Phase II Developmental) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular finances formats (see Specifically, a U.S. organization submitting an software with direct costs in each year of $300,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should utilize the PHS398 Modular Finances component.
All foreign applicants must comprehensive and submit price range requests utilizing the Analysis & Connected Spending budget component.
2. Funds Available
The NCI intends to commit approximately $2,250,000 in FY 2010. The NCI anticipates funding up to 7 awards. The total project period for an application submitted in response to this FOA may not exceed 3 years with a combined spending budget suitable for the science proposed and direct costs cannot exceed $300,000 for any given year.
Because the nature and scope of the proposed investigation will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans with the IC(s) provide support for this method, awards pursuant to this funding option are contingent upon the availability of funds.
Facilities and Administrative (F&A) costs requested by consortium participants are not included inside the direct cost limitation. See NOT-OD-05-004.
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.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The subsequent organizations/institutions are eligible to apply:
Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) Small Businesses For-Profit Organizations (Other than Small Businesses) State Governments U.S. Territory or Possession Non-domestic (non-U.S.) Entities (Foreign Organizations) Eligible Agencies of your Federal Government
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an software for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional details on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual study projects is available at All PDs/PIs should be registered inside the NIH electronic Investigation Administration (eRA) Commons prior to the submission from the application (see for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of your investigators and applicant organizations and should be determined through the scientific goals with the project. Purposes for grants with multiple PDs/PIs will require additional information, as outlined inside the instructions under. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience from the individual PDs/PIs will be factored into the assessment of the overall scientific merit from the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as suitable, to a collaborating organization, for the proper conduct of your project or method, including the submission of required reports. For further information on multiple PDs/PIs, please see
2. Cost Sharing or Matching
This program does not require cost sharing as defined inside the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number of Applications. Applicants may submit more than one software, provided each software is scientifically distinct.
Resubmissions. Applicants may submit a resubmission software, but such application should include an Introduction addressing the previous peer assessment critique (Summary Statement). Beginning with purposes supposed for the January twenty five, 2009 official submission due date, all original new purposes (i.e.,
Microsoft Office 2007, never submitted) and competing renewal apps will be permitted only a single amendment (A1). See and NOT-OD-09-016. Original new and competing renewal purposes that were submitted prior to January twenty five, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications,
Microsoft Office 2007 Enterprise, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 apps after that date.
Renewals. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) apps will not be accepted.
Section IV. Software and Submission Information
To download a SF424 (R&R) Software Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) varieties for this FOA, use the Apply for Grant Electronically button in this FOA or link to and follow the directions provided on that Web site.
To download a SF424 (R&R) Software Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) types for this FOA, utilize the Apply for Grant Electronically button in this FOA or link to and adhere to the directions provided on that Web site.
Registration:
Appropriate registrations with Grants.gov and eRA Commons should be completed on or prior to the because of date in order to successfully submit an software. Several of your steps from the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations have to be complete by the submission deadline for your software for being deemed on-time (see 3.C.1 for more details about on-time submission).
A one-time registration is required for institutions/organizations at both:
Grants.gov ( and eRA Commons (
PDs/PIs should work with their institutions/organizations to make sure they are registered within the NIH eRA Commons.
Several additional separate actions are required just before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
Your organization will need to obtain a Data Universal Number System (DUNS) range and register with the Central Contractor Registration (CCR) as part from the Grants.gov registration process. If your organization does not have a Taxpayer Identification Range (TIN) or Employer Identification Amount (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration. The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days. Direct questions regarding Grants.gov registration to:
Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email support@grants.gov
2) Organizational/Institutional Registration inside the eRA Commons
To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons. Direct questions regarding the Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email commons@od.nih.gov
3) Project Director/Principal Investigator (PD/PI) Registration inside the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
The individual designated as the PD/PI on the software must also be registered from the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov. The PD/PI should hold a PD/PI account within the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI. This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Commons. Both the PD/PI and AOR/SO need separate accounts within the NIH eRA Commons since both are authorized to view the software image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS quantity is required and the same DUNS quantity have to be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) types.
1. Request Software Information
Applicants need to download the SF424 (R&R) software forms and the SF424 (R&R) Software Guide for this FOA through Grants.gov/Apply.
Note: Only the types package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample types, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.
For further support, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.
Telecommunications for your hearing impaired: TTY: (301) 451-5936
2. Content and Kind of Software Submission
Prepare all programs employing the SF424 (R&R) software kinds and in accordance with the SF424 (R&R) Software Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a total and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field with the Analysis & Connected Senior/Key Person Profile component need to contain the PD/PIs assigned eRA Commons User ID). Agency-specific guidelines for such fields are clearly identified from the Application Guide. For additional details, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) software has several components. Some components are required, others are optional. The kinds package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the subsequent components:
Required Components:
SF424 (R&R) (Cover component)
Research & Connected Project/Performance Site Locations
Research & Related Other Project Information
Research & Relevant Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Investigation Plan
PHS398 Checklist
PHS398 Modular Budget or Investigation & Connected Spending budget, as proper (See Section IV.six., Special Instructions, regarding suitable required price range component.)
Optional Components:
PHS398 Cover Letter File
Research & Connected Subaward Budget Attachment(s) Form
Foreign Organizations (Non-Domestic [non-U.S.] Entities)
NIH policies concerning grants to Foreign (non-U.S.) organizations can be found inside the NIH Grants Policy Statement at:
Applications from Foreign organizations must:
Request budgets in U.S. dollars; Prepare detailed budgets for all applications (that is, total the Research & Connected Price range component of your SF424 (R&R) software kinds not the PHS398 Modular Price range component)(see NOT-OD-06-096); Not include any charge-back of customs and import fees; Comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF; If proper, request funds for up to 8% administrative costs (excluding equipment) ( see NOT-OD-01-028, March 29, 2001); Comply with Federal/NIH policies on human subjects, animals, and biohazards; and Comply with Federal/NIH biosafety and biosecurity regulations (see Section VI.2., Administrative and National Policy Needs).
Proposed investigation should provide special opportunities for furthering analysis programs via the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available within the United States (U.S.) or that augment existing U.S. resources.
SPECIAL Guidelines
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to get designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the software materials outlined under, and for coordinating progress reports for your project. The contact PD/PI must meet all eligibility specifications for PD/PI status within the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team outside of those mentioned above.
Information for the Contact PD/PI should be entered in item 15 from the SF424 (R&R) Cover component. All other PDs/PIs should be listed from the Investigation & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs should be registered from the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field with the Study & Relevant Senior/Key Person component. Failure to include this data field will cause the software to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for your proposed project.
Multiple PD/PI Leadership Plan: For programs designating multiple PDs/PIs, a new section from the Study Plan, entitled Multiple PD/PI Leadership Plan, has to be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure with the leadership team and the study project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or plan should be delineated for your PDs/PIs and other collaborators.
If price range allocation is planned, the distribution of resources to specific components with the project or the individual PDs/PIs should be delineated inside the Leadership Plan. Inside the event of an award, the requested allocations may be reflected in a footnote on the Discover of Award (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, adhere to the guidelines contained from the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for your other institution(s) must be requested via a subcontract to be administered through the prime institution. When submitting a detailed budget, the prime institution should submit its spending budget utilizing the Investigation & Relevant Spending budget component. All other institutions should have their individual budgets attached separately to the Research & Associated Subaward Price range Attachment(s) Kind. See Section 4.8 with the SF424 (R&R) Software Guide for further instruction regarding the use with the subaward finances type.
When submitting a modular finances, the prime institution completes the PHS398 Modular Finances component only. Data concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when making use of the Modular budget format. See Section 5.4 of your Software Guide for further instruction regarding the use of the PHS398 Modular Price range component.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Evaluation, and Anticipated Start Dates
Opening Date: January 23, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 23, 2010; April 27, 2010; August 30, 2010
NOTE: On-time submission requires that purposes be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of your applicant institution/organization).
Application Because of Date(s): February 23, 2010; May 27, 2010; September 30, 2010
Peer Review Date(s): May/June 2010; August/September 2010; January/February 2011
Council Critique Date(s): October 2010; January 2011; May 2011
Earliest Anticipated Start Date(s): December 2010; April 2011; July 2011
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the subsequent information:
Descriptive title of proposed study. Name, address, and telephone number with the PD(s)/PI(s). Names of other key personnel. Collaborating institutions. Amount and title of this funding possibility.
Although a letter of intent is not required, is not binding, and does not enter into the assessment of a subsequent application, the details that it contains allows IC staff to estimate the potential evaluation workload and plan the critique.
The letter of intent is always to be sent by the date listed in Section IV.3.A.
The letter of intent should be sent to:
raragon@mail.nih.gov
3.B. Submitting an Software Electronically to the NIH
To submit an software in response to this FOA, applicants should access this FOA via and stick to Steps 1-4. Notice: Programs need to only be submitted electronically.
PAPER Apps WILL NOT BE ACCEPTED.
In order to expedite the assessment, applicants are requested to notify the Countrywide Cancer Institutes Referral Office by email ncirefof@dea.nci.nih.gov when the application has long been submitted. Please include the FOA number and title, PD/PI name, and title from the application.
3.C. Software Processing
3.C.1 Submitting On-Time
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (from the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted from the because of date(s) and time, the software may be delayed within the assessment process or not reviewed. All purposes ought to meet the following criteria to be thought to be on-time:
All registrations have to be full prior to the submission deadline The application ought to receive a Grants.gov tracking quantity and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date. Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.
Please visit for detailed info on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step - applicants should stick to their software by way of to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
Crucial Be aware! NIH has removed the error correction window for because of dates of January 25, 2011 and over and above. As of January twenty five, all corrections should be complete by the due date for an application to get deemed on-time. See NOT-OD-10-123.
Once an application package has become successfully submitted via Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings ahead of a final assembled application is created inside the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the software from completing the submission process.
Please observe that the subsequent caveats apply:
Initial application submission has to be on-time. The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes. Proof of on-time submission (e.g., Grants.gov timestamp and tracking quantity) and description of all changes made within the window should be documented in the PHS 398 Cover Letter component of the software.
3.C.3 Viewing an Application from the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled software ahead of it automatically moves forward to NIH for further processing.
If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral from the Center for Scientific Evaluation for processing after two weekdays, excluding Federal holidays. Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part with the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected software. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should stick to the directions for correcting errors in Section 2.12, including the requirement for cover letters on late purposes. The Reject feature should also be used if you determine that warnings are applicable to your software and need for being addressed now. Remember, warnings do not stop further software processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process. If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly mirror the submitted application package (e.g., some portion of your application was lost or did not transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue. If the AOR/SO chooses to Reject the image after the submission deadline for the reason other than an eRA Commons or Grants.gov system failure, a changed/corrected software still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained within the cover letter attachment. Both the AOR/SO and PD/PI will receive e-mail notifications when the software is rejected or the software automatically moves forward within the process after two weekdays.
Upon receipt, apps will be evaluated for completeness from the CSR and responsiveness by the IC. Incomplete and non-responsive purposes will not be reviewed.
There will be an acknowledgement of receipt of programs from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Details associated to the assignment of an software to a Scientific Review Group is also inside the Commons.
Note: Since email can be unreliable, it is the responsibility of your applicant to check periodically on the application status from the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit evaluation unless the applicant withdraws the pending software. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such software ought to include an Introduction addressing the critique from the previous evaluation.
4. Intergovernmental Assessment
This initiative is not subject to intergovernmental assessment.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described within the NIH Grants Policy Statement.
Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days just before the beginning date with the initial finances period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee should obtain NIH approval just before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days ahead of the beginning date with the initial spending budget period of a new or renewal award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of your approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to get fully aware that pre-award costs result in borrowing against future support and that such borrowing need to not impair the grantee's ability to accomplish the project objectives within the approved time frame or in any way adversely affect the conduct of your project (see the NIH Grants Policy Statement).
6. Other Submission Requirements
Investigators will be convened annually throughout the project period to discuss challenges/progress and share findings. Support for travel from the Principal Investigator and one co-investigator to participate inside the annual PI meeting should be included from the proposed finances. For that purposes of estimating budgets - plan on a 2-day meeting each year, with the location alternating between the east and west coasts with the continental United States.
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID within the PROFILE Project Director/Principal Investigator section, Credential log-in field from the Study & Relevant Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS range in its Organization Profile within the eRA Commons. This DUNS number must match the DUNS amount provided at CCR registration with Grants.gov. For additional details, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Programs.
PHS398 Investigation Plan Component Sections
All software recommendations outlined within the SF424 (R&R) Application Guide are to get followed, incorporating "Just-in-Time" info concepts, and with the subsequent specifications for R33 apps:
The non-modular, detailed price range format is to be used irrespective with the requested price range amount; in other words, the solicited R33 programs should not use the NIH modular finances format. The Investigation Strategy may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. Introduction (required to get a resubmission software) is limited to one page. Preliminary data are required as part of your application. Renewal (formerly competing continuation or Variety 2) purposes are not permitted.
Other Specific Guidelines for Preparation of an R33 Application
R33 applicants need to present detailed preliminary data in support of the feasibility of your proposed technology or approach that is proposed for growth. Whereas R33 applications by definition must deal with technologies that are outside of the inception stage, applicants must demonstrate the innovation of your particular technology or approach proposed for improvement inside the terms of applied science (e.g., by pointing to a gap in currently available capabilities or to a potential for substantial improvements/advantages over the currently used solutions). Please be aware that there is actually a strict 12-page limit for the Study Strategy Section of all R33 applications.
Preliminary Studies/Progress Report. This section should document the feasibility from the proposed technology and approaches (e.g., based on successful preliminary studies equivalent in scope to an R21 pilot project). The applicant need to clearly describe how the prior exploratory study is ready to be scaled up to an expanded developmental stage. From the event that an applicant feels that the underlying technology is too proprietary to disclose, the applicant ought to at a minimum provide a demonstration (results) from the capabilities of the proposed technology. Preliminary data relevant to both the technology evaluation and the pilot biological study should be presented.
Note for R33 applicants proposing to continue study begun under R21 support: the Investigation Strategy attachment need to quote the final Milestones from the R21 Discover of Award and discuss the extent to which these milestones have been achieved. This discussion should comprise no more than three pages (which count toward the 12-page limit).
Additional Software Recommendations:
In the Significance section with the Investigation Plan, the applicant ought to provide (under a separate sub-heading) a short narrative on the innovation and potentially transformative nature of the technology. The subsequent questions should be addressed:
How is the technology potentially transformative and why may it be expected to produce an unusually high impact on biomedical investigation? What are the pioneering approaches for which the potential for groundbreaking or paradigm-shifting results compensates and justifies any associated risks? What concrete evidence can be provided to substantiate the claim of innovativeness?
Other Budgetary Needs. An annual meeting of all investigators funded through this plan will be held to share progress and analysis insights that may lead to further progress from the plan. From the budgets, applicants must include travel expenses for the PD/PI and one additional senior investigator to attend this annual meeting.
Intellectual Property Management
Certain investigation plans will require collaboration and coordination between investigators at different institutions, some of whom may not be NIH funding recipients and who may have pre-existing intellectual property obligations to third parties. It is anticipated that commercial embodiments from the results of such research may incorporate single inventions shared by several institutions, or multiple inventions each from a separate institution. Therefore, prior to funding, R33 grant applicants should address how they will coordinate patent prosecution and licensing activities, if necessary to enable a licensee to access the bundle of intellectual property needed to take a product to market on commercially viable terms. Suggested strategies include: (1) assigning intellectual property rights to associated inventions to an invention management firm; (2) designating one organization to take the lead on patenting and licensing related inventions; and (3) agreeing in advance that if multiple parties are to independently license-related inventions, the total of stacked royalties will not exceed a predetermined percentage rate.
The technology transfer/ intellectual property management/licensing officer or equivalent with the PI's institution is expected to submit an intellectual property management plan, including at least those elements above. Alternatives to the suggested strategies, which accomplish the same goals, will be regarded as. Intellectual property management plans are a just-in-time requirement and do not need to get included inside the grant application but will be required before an R33 grant can be awarded.
The applicant's institution should avoid exclusively licensing those inventions that are study tools unless either: (1) the field of use with the exclusive license is restricted to commercial use; or (2) the exclusive licensee will make the analysis tool available on reasonable terms. Applicants are directed to the NIH policy on the dissemination of biological analysis resources (study tools) at
Appendix Materials
Applicants must follow the specific recommendations on Appendix materials as described within the SF424 (R&R) Software Guide (See Also see
Do not utilize the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed from the review process.
Resource Sharing Plan(s)
NIH considers the sharing of unique study resources developed by way of NIH-sponsored analysis an critical means to enhance the value and further the advancement with the analysis. When resources have been developed with NIH funds and the associated analysis findings published or provided to NIH, it is crucial that they be made readily available for study purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this should be explained inside the Resource Sharing section of your application (see
(a) Data Sharing Plan: Regardless of your amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or
(b) Sharing Model Organisms: Regardless from the amount requested, all apps where the advancement of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and relevant resources or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NOT-OD-04-042.)
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for the genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an suitable explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further info see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and
Foreign Programs (Non-domestic (non-U.S.) Entity)
Indicate how the proposed project has specific relevance to the mission and objectives of your NIH/IC and has the potential for significantly advancing the health sciences from the United States.
Section V. Application Evaluation Information
1. Criteria
Only the assessment criteria described under will be thought to be in the evaluation process.
2. Review and Variety Process
Review Process
Applications that are full and responsive to this FOA will be evaluated for scientific and technical merit by an acceptable peer assessment group convened through the National Cancer Institute and in accordance with NIH peer critique procedures ( utilizing the critique criteria stated beneath.
As component of your scientific peer review, all purposes will:
Undergo a assortment process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of apps under evaluation, will be discussed and assigned a rating; Receive a written critique; and Receive a second level of evaluation through the Nationwide Cancer Advisory Board
Because the Research Strategy component is limited to 12 pages, an exploratory/developmental grant application need not have extensive background material or preliminary info as one might normally expect in an R01 software. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications. Suitable justification for that proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are required for R33 apps and should focus on demonstration of technical feasibility.
The mission with the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As portion of this mission, programs submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral investigation are evaluated for scientific and technical merit via the NIH peer assessment system.
Overall Impact. Reviewers will provide an overall impact/priority score to replicate their assessment from the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional assessment criteria (as applicable for your project proposed).
Core Critique Criteria. Reviewers will consider each of your five assessment criteria under from the determination of scientific and technical merit, and give a separate score for each. An application does not need to get 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 critical problem or a critical barrier to progress inside the field? If the aims from the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion with the aims change the concepts, methods, technologies, treatments, providers, 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, do they have proper 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 study 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 analysis or novel in a broad sense? Can be a refinement, improvement, or new software of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and proper to accomplish the specific aims from the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of improvement, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical study, are the plans for 1) protection of human subjects from analysis risks, and 2) inclusion of minorities and members of both ######es/genders, as well as the inclusion of children, justified in terms from the scientific goals and investigation 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 your project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Evaluation Criteria
As applicable for the project proposed, reviewers will consider the subsequent additional items within the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one with the six categories of investigation that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from analysis risk relating to their participation according to the following five evaluation criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance with the knowledge to get gained, and 5) data and safety monitoring for clinical trials.
For study that involves human subjects and meets the criteria for one or more of the six categories of investigation that are exempt under 45 CFR Component 46, the committee will evaluate: 1) the justification for that exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical analysis, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as component of your scientific assessment according to the subsequent five points: 1) proposed use from the animals, and species, strains, ages, ######, and numbers for being used; 2) justifications for your use of animals and for the appropriateness of your species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable within the conduct of scientifically sound analysis including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for choice if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Applications. When reviewing a Resubmission software (formerly called an amended software), the committee will evaluate the software as now presented, taking into consideration the responses to comments from the previous scientific assessment group and changes made to the project.
Revision Applications. When reviewing a Revision software (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope with the project. If the Revision application relates to a specific line of investigation presented within the original software that was not recommended for approval through the committee, then the committee will consider whether the responses to comments from the previous scientific assessment group are adequate and whether substantial changes are clearly evident.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to study personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Evaluation Considerations
As applicable for that project proposed, reviewers will address each of the subsequent items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents Study. Reviewers will assess the data provided in this section with the application, including 1) the Select Agent(s) to get used inside the proposed investigation, 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 proper biosafety, biocontainment, and security from the Select Agent(s).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering investigation programs by means of 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.
Resource Sharing Plans. Reviewers will comment on whether the subsequent Resource Sharing Plans, or the rationale for not sharing the subsequent types of resources, are reasonable: 1) Data Sharing Plan ( 2) Sharing Model Organisms ( and 3) Genome Wide Association Studies (GWAS) (
Selection Process
Applications submitted in response to this FOA will compete for available funds with all other recommended apps submitted in response to this FOA. The subsequent will be deemed in making funding decisions:
Scientific merit with the proposed project as determined by peer review. Availability of funds. Relevance of your proposed project to program priorities.
3. Anticipated Announcement and Award Dates
See Section IV.3.A
Section VI. Award Administration Information
1. Award Notices
After the peer evaluation of your application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding, NIH will request "just-in-time" info from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
A formal notification within the type of a Recognize of Award (NoA) will be provided to the applicant organization. The NoA signed from the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.
Selection of an software for award is not an authorization to begin performance. Any costs incurred ahead of receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent thought to be allowable pre-award costs. See Section IV.5., Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as component of your NoA. For these terms of award, see the NIH Grants Policy Statement Portion 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.
3. Reporting
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.
Section VII. Agency Contacts
We encourage your inquiries concerning this funding chance and welcome the chance to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (plan), peer critique, and financial or grants management issues:
1. Scientific/Research Contact(s):
Richard Aragon, Ph.D.
Office of the Director
Nationwide Cancer Institute (NCI)
11400 Rockville Pike, Suite 700
Rockville, MD 20852-2580
Telephone: (301) 435-8437
Fax: (301) 480-4814
Email: raragon@mail.nih.gov
J. Randy Knowlton PhD
Division of Cancer Biology (DCB)
Countrywide Cancer Institute
6130 Executive Boulevard, Room 5006
Rockville, MD 20892
Telephone: (301) 435-5226
Fax: (301) 480-2854
E-mail: jk339o@nih.gov
Mukesh Verma, Ph.D.
Division of Cancer Control and Population Sciences (DCCPS)
Countrywide Cancer Institute (NCI)
6130 Executive Boulevard, Room 5100
Bethesda, MD 20892-7324
Rockville, MD 20852
Telephone: (301) 594-7344
Fax: (301) 402-4279
Email: vermam@mail.nih.gov
Lynn Sorbara, Ph.D.
Division of Cancer Prevention (DCP)
Countrywide Cancer Institute
6130 Executive Boulevard, Room 3137
Rockville, MD 20852-7362
Telephone: (301) 435-0584
Fax: (301) 402-8990
E-Mail: lynns@mail.nih.gov
Avraham Rasooly, Ph.D.
Division of Cancer Treatment and Diagnosis (DCTD)
Nationwide Cancer Institute
6130 Executive Boulevard, Room 6024
Rockville, MD 20852-7420
Telephone: (301) 402-4185
Fax: (301) 402-7819
Email: ar338b@nih.gov
2. Peer Evaluation Contact(s):
Referral Officer
Division of Extramural Activities
National Cancer Institute (NCI)
6116 Executive Blvd, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for US Postal Express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov
3. Financial/Grants Management Contact(s):
Emily Tran
Office of Grants Administration
National Cancer Institute (NCI)
6120 Executive Boulevard, EPS Suite 243, MSC 7150
Bethesda, MD 20892-7150
Phone: (301) 496-7249
Fax: (301) 496-8601
E-mail: trane@mail.nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in Study:
Recipients of PHS support for activities involving live, vertebrate animals ought to comply with PHS Policy on Humane Care and Use of Laboratory Animals ( as mandated from the Health Research Extension Act of 1985 ( and the USDA Animal Welfare Regulations ( as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that apps and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits with the investigation to the subjects and others, and the importance with the knowledge gained or to become gained (
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,
Sharing Study Data:
Investigators submitting an NIH software seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible ( Investigators should seek guidance from their institutions, on issues associated to institutional policies and local institutional critique board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.
Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence well being and disease by means of a centralized GWAS data repository. For that purposes of this policy, a genome-wide association study 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. All purposes, regardless from the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an suitable explanation why submission to the repository is not possible. Data repository management (submission and access) is governed from the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional data, see
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of essential analysis resources including the sharing of model organisms for biomedical research (see At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH software or contract proposal are expected to include within the application/proposal a description of a specific plan for sharing and distributing unique model organism investigation resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to get included in all apps where the advancement of model organisms is anticipated.
Access to Analysis Data by way of the Freedom of Information Act:
The Office of Management and Finances (OMB) Circular A-110 continues to be revised to provide access to investigation data by means of the Freedom of Info Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in component with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed via FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for your data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include data about this in the price range justification section from the software. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Inclusion of Women And Minorities in Clinical Investigation:
It is the policy of the NIH that women and members of minority groups and their sub-populations have to be included in all NIH-supported clinical analysis projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health from the subjects or the objective of your study. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical analysis should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Analysis ( a complete copy from the updated Guidelines is available at The amended policy incorporates: the use of an NIH definition of clinical investigation; up-to-date racial and ethnic categories in compliance with the brand new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all apps or proposals and/or protocols ought to provide a description of plans to conduct analyses, as acceptable, to address differences by ######/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators should report annual accrual and progress in conducting analyses, as appropriate, by ######/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) has to be included in all clinical study, conducted or supported from the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing analysis involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in study involving human subjects (
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH purposes for investigation involving human subjects and individuals designated as key personnel. The policy is available at
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of analysis on hESCs can be found at and at Only investigation utilizing hESC lines that are registered within the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( It is the responsibility of your applicant to provide in the project description and elsewhere from the application as suitable, the official NIH identifier(s) for that hESC line(s) to get used from the proposed analysis.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH should submit or have submitted for them to the Countrywide Library of Medicines PubMed Central (see an electronic model of their final, peer-reviewed manuscripts upon acceptance for publication, to become made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at ( For more information, see the Public Access webpage at
Standards for Privacy of Individually Identifiable Health Info:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Wellbeing Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule can be a federal regulation under the Wellbeing Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable wellbeing information, and is administered and enforced through the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation with the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides info on the Privacy Rule, including a total Regulation Text and a set of decision tools on "Am I a covered entity?" Data on the impact with the HIPAA Privacy Rule on NIH processes involving the critique, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at
URLs in NIH Grant Applications or Appendices:
All apps and proposals for NIH funding have to be self-contained within specified page limitations. For publications listed within the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers have to be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section with the NIH grant application. A URL or PMC submission identification quantity citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.
Healthy People 2010:
The Public Well being Service (PHS) is committed to achieving the wellbeing promotion and disease prevention objectives of "Healthy People 2010," a PHS-led nationwide activity for setting priority areas. This FOA is related to one or more of your priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at
Authority and Regulations:
This plan is described from the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental critique demands of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 from the Public Wellbeing Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Portion 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described inside the NIH Grants Policy Statement.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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, well being care, or early childhood growth companies are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental well being of the American people.
Loan Repayment Programs:
NIH encourages purposes for educational loan repayment from qualified well being professionals who have made a commitment to pursue a investigation career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an crucial component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered through the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP apps are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees need to commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see:
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