Part I Overview Details
Department of Wellbeing and Human Solutions
Participating Organizations
National Cancer Institute (NCI), (
Title: Validation and Superior Advancement of Emerging Technologies in Biospecimen Science (R33)
Announcement Sort
This Funding Possibility Announcement (FOA) can be a reissue of RFA-CA-09-005.
Update: The following update referring to this announcement has become issued:
August sixteen, 2010 - Critical Note! NIH has eliminated the error correction window for because of dates of January twenty five, 2011 and beyond. As of January twenty five, all corrections have to be full by the because of date for an software to get thought to be on-time. See NOT-OD-10-123. February 19, 2010 - See Observe NOT-CA-10-018 The purpose of this Discover is to clarify the Finances Kind . January six, 2010 - This FOA has been updated to replicate the new demands from NIH’s Enhancing Peer Assessment Initiative. The brand new requirements are successful for submissions intended for because of dates January twenty five, 2010 and beyond. If submitting an application meant for any because of date of January 25, 2010 and outside of, comply with the guidance under and be certain to work with the Adobe-Forms-B edition with the application forms and recommendations. If applying for a because of date just before January twenty five, 2010, comply with the advice within the archived version of this FOA and be sure to use the Adobe-Forms-A edition of your application forms and recommendations. October 26, 2009 - See Recognize NOT-CA-10-005 Selection of Acceptable Funding Possibility Announcements (FOAs) for the Continuation with the Progressive Technologies for Molecular Analysis of Cancer (IMAT) System .
Request for Apps (RFA) Quantity: RFA-CA-10-002
NOTICE: Apps submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance has to be submitted electronically via Grants.gov ( utilizing the SF424 Analysis and Connected (R&R) kinds and the SF424 (R&R) Software Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA has 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 before 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 Assistance Quantity(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 software may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 23, 2010; April 27, 2010; August 30,
Office 2010 Product Key, 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 Assessment Date(s): May/June 2010; August/September 2010; January/February 2011
Council Assessment Date(s): October 2010; January 2011; May 2011
Earliest Anticipated Start Date(s): December 2010; April 2011; July 2011
Additional Info To become Available Date (Activation Date): Not Applicable
Expiration Date: October 1, 2010
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Objective. This Funding Opportunity Announcement (FOA), issued through the Countrywide Cancer Institute (NCI), National Institutes of Health (NIH), solicits grant apps proposing technically modern feasibility studies focused on the superior improvement and validation of cancer-relevant technologies that address the issues connected to pre-analytical variations within the collection, processing, handling, and storage of biospecimens or its derivatives. The overall goal would be 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 development 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 purposes; this mechanism is suitable for projects where proof-of-principle with the proposed technology or methodology has already been established and supportive preliminary data are available. Projects proposing to work with established technologies where the novelty resides from the biological or clinical question being pursued is an example of a topic not proper for this solicitation and will be returned as non-responsive. This funding chance is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program. 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 programs under the NIH Exploratory/Developmental R21 grant mechanism. Funds Available and Anticipated Amount 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. Finances and Project Period. An applicant for an R33 grant may request a project period of up to 3 years with a spending budget suitable to the science proposed. Direct costs cannot exceed $300,000 for any given year. Software Investigation Strategy Length: The R33 application Analysis Strategy section of 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 investigation are invited to work with their institution/ 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. Amount of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the software. Amount of Apps. Applicants may submit more than one application, provided each software is scientifically distinct. Resubmissions. Applicants may submit a resubmission software, but such application need to include an Introduction addressing the previous peer critique critique (Summary Statement). See new NIH policy on resubmission (amended) programs (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 because of dates. See Receipt, Critique and Anticipated Start Dates. Application Materials. See Section IV.1 for application materials. All apps, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, should utilize the most current kinds and guidelines. General Data. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites: SF424 (R&R) Software and Electronic Submission Details: General information on Electronic Submission of Grant Apps: 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. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Info
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Application and Submission Data
1. Request Software Data
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Critique, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Software Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Needs
Section V. Application Assessment Details
1. Criteria
2. Critique and Choice Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Details
1. Award Notices
2. Administrative and National Policy Specifications
3. Reporting
Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Critique Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Chance Description
1. Investigation Objectives
Purpose
This Funding Chance Announcement (FOA) solicits grant purposes proposing investigation 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 investigation and medicine. The thrust of effort inside the projects proposed in response to this FOA should be on the sophisticated improvement of a technology, rather than on its initial inception and pilot stage improvement. In this FOA, the Nationwide Cancer Institute (NCI) solicits grant applications proposing research projects focused on the growth of novel rising 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 research into cancer biology, treatment and diagnosis, prevention, control and epidemiology, and/or cancer wellbeing disparities. Applicants are referred to the NCI Office of Biorepositories and Biospecimen Science (OBBR, for any better understanding of the current technology needs from the biospecimen sciences. Technologies of interest to this FOA could conceivably be used to support the various NCI biospecimen initiatives, such as the Cooperative Human Tissue Network (CHTN, and the Minority Biospecimen/Biobanking efforts planned through the NCI Center to Reduce Cancer Health Disparities (
Investigators interested in developing modern and/or rising cancer technologies that are not relevant to the biospecimen sciences should consider applying to associated FOAs that are component of a broader NCI-sponsored Progressive Molecular Evaluation Technologies (IMAT, Plan.
This FOA utilizes the R33 award mechanism for projects proposing the superior development of an rising technology. The R33 mechanism is suitable for technology projects that are at the latter stages of advancement, where technical feasibility has become demonstrated but lack validation within context of its meant 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 advancement, integration, maturation, and dissemination of the most novel and highly revolutionary technologies in support of cancer analysis 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 from the following three connected themes:
1. Progressive Technology Growth for Cancer Research (RFA-CA-10-005), which emphasizes technology growth projects that are centered on the inception and preliminary growth of very early stage, highly revolutionary, high impact technologies for cancer investigation;
2. Rising Technology Development for Cancer Research (RFA-CA-10-003, RFA-CA-10-004), which supports analysis projects on the initial application or use of emerging, transformative technologies in a biological context relevant to the intended 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 improvement and validation of novel technologies to assess, evaluate, and interrogate biospecimens, or analytes thereof, in order to maximize their quality and utility in cancer study.
For more information about the IMAT method, a summary of your suite of FOAs, and links to those FOAs, prospective applicants should consult the IMAT website:
Specific Research Objectives and Scope of this FOA
The main emphasis of this FOA is on the validation and advanced growth of a novel technology to advance the biospecimen sciences, rather than the initial technical growth and inception. Projects proposed in response to this FOA should be pertinent to its overarching objective, i.e., applicants should address the improvement of technologies and methodologies that maximize the quality and utility of biospecimens and/or derived samples for cancer research and medicine. Projects proposed should be revolutionary rather than evolutionary; the conceived technologies should have the potential to dramatically alter the way that research can be pursued.
Responsive technologies encompass relevant techniques, tools, instrumentation, devices, and associated methods. For example, tissue samples have a complex composition because of to mixed normal and diseased cell populations. The direct software 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 evaluation, 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 sophisticated growth of novel technologies that can overcome these challenges when directly implemented on the evaluation of biospecimens. Proposed projects should develop and/or utilize novel cancer-related biospecimen/sample preparation, extraction, or transport methodologies/technologies to ensure suitable, consistent, and well-controlled sample quality that is necessary in investigation and/or for clinical use. The improvement 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 study and/or aim to reduce cancer-related well being 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 from the NCI Best Practices for Biospecimen Resources, which can be found at
Applicants responding to this FOA should meet the subsequent general needs (for details see Section IV.6. Other Submission Requirements and Information; Additional Application Directions):
The software is focused on the validation and advanced improvement of an revolutionary 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 investigation or for broad potential use in cancer study. All proposed purposes, should offer the potential for substantial improvements over conventional approaches and/or add qualitatively new investigation capabilities not provided by current technologies. The application must clearly define the novelty with the proposed technology and describe its anticipated use in a research laboratory and/or a clinical setting.
The following aspects/characteristics remain outside the scope of IMAT and this FOA. Purposes proposing any of the following will be returned to the applicant as non-responsive without assessment.
Projects focused on the elucidation with the effects of pre-analytical variations in biospecimen collection,
Windows 7 Ultimate Key, processing, handling, or storage; Projects focused on a biological or clinical hypothesis (i.e. traditional biological-hypothesis driven study); Projects that propose to use existing (off the shelf) technologies without substantial new development and projects which propose only incremental technical advances to existing technologies; Projects focused primarily on software/informatics solutions, database growth, 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 advancement of specific contrast agents; Projects focused on development of specific drugs or therapies.
Researchers focusing on hypothesis-based biospecimen investigation should consider one of your opportunities from the NCI Office of Biorepositories and Biospecimen Investigation (
Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software solutions should consider one of your Biomedical Details 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 Program (CIP, for data on appropriate funding opportunities.
Related IMAT FOAs: Applicants considering projects focused on innovative technologies that are in its earliest stages of advancement or inception should consider relevant IMAT FOA RFA-CA-10-001. Applicants considering projects on emerging technologies whose intended use does not address biospecimen/sample quality should consider related IMAT FOAs RFA-CA-10-003 and RFA-CA-10-004.
Researchers who are unclear as to which of the IMAT FOAs might be most acceptable for their proposed technology development project are encouraged to contact the system official listed in this FOA.
Attributes of your NIH R33 Mechanisms in the IMAT context. The R33 mechanism is meant to support the innovative stages of technology improvement for those projects in which feasibility has long been demonstrated, but not in context of its meant use or application. Proposed projects are expected to be 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 be full and responsive to IMATs R33 FOAs, all programs need to include feasibility (proof-of-concept) data via prior study, 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 utilize 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 data concepts (see SF424 (R&R) Software Guide). It also uses the modular as well as the non-modular spending budget 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 should complete and submit budget requests utilizing the Research & 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 software submitted in response to this FOA may not exceed 3 years with a combined budget acceptable for that science proposed and direct costs cannot exceed $300,000 for any given year.
Because the nature and scope with the proposed research will vary from application to software, 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 system, awards pursuant to this funding possibility are contingent upon the availability of funds.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the programs 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 from the Federal Government
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed study 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 software for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information 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 have to be registered from the NIH electronic Investigation Administration (eRA) Commons prior to the submission of your software (see for recommendations).
The decision of whether to apply to get a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility with the investigators and applicant organizations and should be determined by the scientific goals of your project. Programs for grants with multiple PDs/PIs will require additional information, as outlined from the instructions under. When considering the multiple PD/PI option, please be aware that the structure and governance from the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment with the overall scientific merit of your 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 acceptable, to a collaborating organization, for that proper conduct of the project or plan, including the submission of required reports. For further details on multiple PDs/PIs, please see
2. Cost Sharing or Matching
This method does not require cost sharing as defined from the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number of Apps. Applicants may submit more than one software, provided each software is scientifically distinct.
Resubmissions. Applicants may submit a resubmission software, but such application must include an Introduction addressing the previous peer evaluation critique (Summary Statement). Beginning with apps meant for the January twenty five, 2009 official submission because of date, all original new applications (i.e., 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 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered apps, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) programs will not be accepted.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424 (R&R) Software Guide for completing the SF424 (R&R) types for this FOA, use the Apply for Grant Electronically button in this FOA or link to and stick to the directions provided on that Web site.
To download a SF424 (R&R) Software Package and SF424 (R&R) Software Guide for completing the SF424 (R&R) kinds 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 before the due date in order to successfully submit an software. Several from the steps with 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 has to be comprehensive from the submission deadline for your software to be 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 positive they are registered in the NIH eRA Commons.
Several additional separate actions are required just before an applicant can submit an electronic software, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
Your organization will need to obtain a Data Universal Quantity System (DUNS) amount and register with the Central Contractor Registration (CCR) as component with the Grants.gov registration process. If your organization does not have a Taxpayer Identification Range (TIN) or Employer Identification Quantity (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 in 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 from the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov. The PD/PI must hold a PD/PI account from the Commons and have to be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI. This registration/affiliation has to be done from the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered within the Commons. Both the PD/PI and AOR/SO need separate accounts inside the NIH eRA Commons since both are authorized to view the application 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 amount. Only one DUNS number is required and the same DUNS range must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) types.
1. Request Software Info
Applicants should download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA via Grants.gov/Apply.
Note: Only the kinds package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) varieties (e.g., sample varieties, kinds from another FOA), although some of the "Attachment" files may be useable for more than one FOA.
For further guidance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.
Telecommunications for your hearing impaired: TTY: (301) 451-5936
2. Content and Type of Application Submission
Prepare all applications employing the SF424 (R&R) software types and in accordance with the SF424 (R&R) Application Guide for this FOA by way of Grants.gov/Apply.
The SF424 (R&R) Software Guide is critical to submitting a total and accurate software 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 Study & Relevant Senior/Key Person Profile component need to contain the PD/PIs assigned eRA Commons User ID). Agency-specific directions for such fields are clearly identified in the Software Guide. For additional data, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Apps.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed software in response to this FOA includes the data inside the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Relevant Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Analysis Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Connected Budget, as suitable (See Section IV.six., Special Guidelines, regarding acceptable required price range component.)
Optional Components:
PHS398 Cover Letter File
Research & Relevant Subaward Finances Attachment(s) Form
Foreign Organizations (Non-Domestic [non-U.S.] Entities)
NIH policies concerning grants to Foreign (non-U.S.) organizations can be found from the NIH Grants Policy Statement at:
Applications from Foreign organizations need to:
Request budgets in U.S. dollars; Prepare detailed budgets for all apps (that is, total the Analysis & Related Budget component with the SF424 (R&R) software forms 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 suitable, 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 Countrywide Policy Demands).
Proposed investigation should provide special opportunities for furthering research programs by means of the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available inside the United States (U.S.) or that augment existing U.S. resources.
SPECIAL Recommendations
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 below, and for coordinating progress reports for the project. The contact PD/PI ought to meet all eligibility demands for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team past those mentioned above.
Information for your 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 Analysis & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs have to be registered from the eRA Commons prior to software submission. The Commons ID of each PD/PI has to be included from the Credential field with the Study & Related Senior/Key Person component. Failure to include this data field will cause the application to get rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for that proposed project.
Multiple PD/PI Leadership Plan: For programs designating multiple PDs/PIs, a new section of your 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 from the leadership team and the research 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 method should be delineated for your PDs/PIs and other collaborators.
If finances allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated from the Leadership Plan. Within the event of an award,
Office 2007 Enterprise, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, stick to the directions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution should be designated as the prime institution and funding for your other institution(s) should be requested via a subcontract for being administered through the prime institution. When submitting a detailed budget, the prime institution should submit its budget making use of the Analysis & Associated Finances component. All other institutions should have their individual budgets attached separately to the Study & Connected Subaward Price range Attachment(s) Kind. See Section 4.8 of your SF424 (R&R) Software Guide for further instruction regarding the use from the subaward budget type.
When submitting a modular price range, the prime institution completes the PHS398 Modular Budget component only. Details concerning the consortium/subcontract spending budget is provided inside the price range justification. Separate budgets for each consortium/subcontract grantee are not required when making use of the Modular budget format. See Section 5.4 with the Software Guide for further instruction regarding the use of the PHS398 Modular Finances component.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Critique, 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 applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (with the applicant institution/organization).
Application Because of Date(s): February 23, 2010; May 27, 2010; September 30, 2010
Peer Assessment Date(s): May/June 2010; August/September 2010; January/February 2011
Council Assessment 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 analysis. Name, address, and telephone number with the PD(s)/PI(s). Names of other key personnel. Participating institutions. Quantity and title of this funding opportunity.
Although a letter of intent is not required, is not binding, and does not enter into the critique of a subsequent software, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent through 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 application in response to this FOA, applicants should access this FOA via and adhere to Steps 1-4. Observe: Apps must only be submitted electronically.
PAPER Apps WILL NOT BE ACCEPTED.
In order to expedite the review, applicants are requested to notify the Countrywide Cancer Institutes Referral Office by email ncirefof@dea.nci.nih.gov when the application has become submitted. Please include the FOA number and title, PD/PI name, and title from the application.
3.C. Application Processing
3.C.1 Submitting On-Time
Applications may be submitted on or after the opening date and has to be successfully received by Grants.gov no later than 5:00 p.m. local time (with the applicant institution/organization) on the software because of date(s). (See Section IV.3.A. for all dates.) If an software is not submitted from the due date(s) and time, the software may be delayed from the evaluation process or not reviewed. All purposes need to meet the following criteria for being thought to be on-time:
All registrations should be total prior to the submission deadline The software should receive a Grants.gov tracking number 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 details 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 need to comply with their software via to the eRA Commons to check for errors and warnings and view their assembled software!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
Essential Notice! NIH has eliminated the error correction window for due dates of January twenty five, 2011 and beyond. As of January 25, all corrections should be full through the because of date for an software to get deemed on-time. See NOT-OD-10-123.
Once an software 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 prior to a final assembled software is created in 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 have to be corrected to successfully full the submission process. Warnings will not prevent the application from completing the submission process.
Please notice that the subsequent caveats apply:
Initial software submission must 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 software 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 have to be documented in the PHS 398 Cover Letter component of the application.
3.C.3 Viewing an Software from the eRA Commons
Once any eRA identified errors have been addressed and the assembled software has long been created within 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 Critique 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 software within the two-day viewing window. This option should be used if it is determined that some portion of your software was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the software and submit a Changed/Corrected application. 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 programs. The Reject feature should also be used if you determine that warnings are applicable to your software and need to become 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 become addressed later inside 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 software does not correctly mirror the submitted software package (e.g., some part of your software 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 to get a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application 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 application automatically moves forward in the process after two weekdays.
Upon receipt, apps will be evaluated for completeness from the CSR and responsiveness through the IC. Incomplete and non-responsive programs will not be reviewed.
There will be an acknowledgement of receipt of purposes from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information associated to the assignment of an software to a Scientific Review Group is also from the Commons.
Note: Since email can be unreliable, it is the responsibility with the 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 assessment 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 application need to include an Introduction addressing the critique from the previous critique.
4. Intergovernmental Review
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 in 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 before the beginning date of the initial spending budget 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 need to obtain NIH approval prior to incurring the cost. NIH prior approval is required for any costs to get incurred more than 90 days before the beginning date from 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 from the approved price range 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 become fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives inside the approved time frame or in any way adversely affect the conduct with the 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 by the Principal Investigator and one co-investigator to participate from the annual PI meeting should be included from the proposed budget. For your 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 inside the PROFILE Project Director/Principal Investigator section, Credential log-in field from the Study & Associated Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS amount in its Organization Profile from the eRA Commons. This DUNS amount ought to match the DUNS number provided at CCR registration with Grants.gov. For additional details, see Frequently Asked Questions Software Guide, Electronic Submission of Grant Apps.
PHS398 Research Plan Component Sections
All application directions outlined in the SF424 (R&R) Application Guide are to become followed, incorporating "Just-in-Time" details concepts, and with the following needs for R33 apps:
The non-modular, detailed finances format is usually to be used irrespective of the requested budget amount; in other words, the solicited R33 apps should not use the NIH modular budget format. The Analysis Strategy may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. Introduction (required for a resubmission application) is limited to one page. Preliminary data are required as aspect from the software. Renewal (formerly competing continuation or Type 2) purposes are not permitted.
Other Specific Guidelines for Preparation of an R33 Application
R33 applicants should present detailed preliminary data in support from the feasibility from the proposed technology or approach that is proposed for improvement. Whereas R33 applications by definition ought to deal with technologies that are over and above the inception stage, applicants must demonstrate the innovation from the particular technology or approach proposed for improvement from 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 observe that there is really a strict 12-page limit for your Research Strategy Section of all R33 purposes.
Preliminary Studies/Progress Report. This section should document the feasibility with the proposed technology and approaches (e.g., based on successful preliminary studies equivalent in scope to an R21 pilot project). The applicant should clearly describe how the prior exploratory study is ready to be scaled up to an expanded developmental stage. Within 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 with 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 research begun under R21 support: the Study Strategy attachment ought 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 Application Guidelines:
In the Significance section of your Investigation Plan, the applicant must 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 Specifications. An annual meeting of all investigators funded via this plan will be held to share progress and analysis insights that may lead to further progress in the program. In the budgets, applicants should include travel expenses for that 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 of your results of such study may incorporate single inventions shared by several institutions, or multiple inventions each from a separate institution. Therefore, prior to funding, R33 grant applicants ought to 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 related 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 of 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 be included inside the grant application but will be required just before an R33 grant can be awarded.
The applicant's institution should avoid exclusively licensing those inventions that are analysis 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 research tool available on reasonable terms. Applicants are directed to the NIH policy on the dissemination of biological research resources (research tools) at
Appendix Materials
Applicants ought to comply with the specific recommendations on Appendix materials as described from the SF424 (R&R) Application Guide (See Also see
Do not use the Appendix to circumvent the page limitations. An software that does not comply with the required page limitations may be delayed within the evaluation process.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed via NIH-sponsored study an essential means to enhance the value and further the advancement of the study. When resources have been developed with NIH funds and the associated analysis findings published or provided to NIH, it is important that they be made readily available for analysis purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained within the Resource Sharing section of your application (see
(a) Data Sharing Plan: Regardless from the amount requested, investigators are expected to include a brief 1-paragraph description of how final investigation 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 of your amount requested, all purposes where the growth of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related 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 with the amount requested, applicants seeking funding for 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. 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 details 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 from the NIH/IC and has the potential for significantly advancing the well being sciences inside the United States.
Section V. Software Review Information
1. Criteria
Only the review criteria described under will be deemed within the review process.
2. Assessment and Choice Process
Review Process
Applications that are full and responsive to this FOA will be evaluated for scientific and technical merit by an acceptable peer review group convened through the Nationwide Cancer Institute and in accordance with NIH peer assessment procedures ( using the evaluation criteria stated beneath.
As portion with the scientific peer assessment, all applications will:
Undergo a assortment process in which only those apps deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned a rating; Receive a written critique; and Receive a second level of evaluation by the Countrywide Cancer Advisory Board
Because the Study Strategy component is limited to 12 pages, an exploratory/developmental grant software need not have extensive background material or preliminary details 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 purposes. Proper justification for your proposed work can be provided by way of 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 usually 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 analysis are evaluated for scientific and technical merit by means of the NIH peer assessment system.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment with the likelihood for the project to exert a sustained, powerful influence on the study field(s) involved, in consideration of the subsequent five core evaluation criteria, and additional review criteria (as applicable for that project proposed).
Core Review Criteria. Reviewers will consider each of the five critique criteria beneath inside the determination of scientific and technical merit, and give a separate score for each. An software does not need for being strong in all categories to get judged likely to have major scientific impact. For example, a project that by its nature is not modern 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 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, 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 suitable for that 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 research or novel in a broad sense? Can be 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 proper to accomplish the specific aims with the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is within the early stages of growth, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical analysis, are the plans for 1) protection of human subjects from research 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 analysis 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 from the scientific environment, subject populations, or collaborative arrangements?
Additional Assessment Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For analysis that involves human subjects but does not involve one of the six categories of investigation that are exempt under 45 CFR Aspect 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from study risk relating to their participation according to the subsequent five critique 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 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 from 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 study, 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 part of your scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, ######, and numbers to become used; 2) justifications for your use of animals and for your appropriateness from the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable inside 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 assortment if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Purposes. When reviewing a Resubmission software (formerly called an amended application), 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 software), the committee will consider the appropriateness from the proposed expansion of the scope of the project. If the Revision software relates to a specific line of investigation presented within 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 assessment group are adequate and whether substantial changes are clearly evident.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to analysis personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Critique 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 finances and the requested period of support are fully justified and reasonable in relation to the proposed investigation.
Select Agents Analysis. Reviewers will assess the information provided in this section of your application, including 1) the Select Agent(s) to be used in the proposed analysis, 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 your Select Agent(s).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering analysis programs by way of the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available inside the United States or augment existing U.S. resources.
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) (
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 following will be considered in making funding decisions:
Scientific merit with the proposed project as determined by peer critique. Availability of funds. Relevance of your proposed project to system priorities.
3. Anticipated Announcement and Award Dates
See Section IV.3.A
Section VI. Award Administration Information
1. Award Notices
After the peer assessment from the software 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" details from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Aspect II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
A formal notification from the form of a Observe 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 application for award is not an authorization to begin performance. Any costs incurred prior to receipt of your NoA are at the recipient's risk. These costs may be reimbursed only to the extent regarded as 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 portion from the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Microsoft Office 2007 Product Key, 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 within 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 possibility and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (method), peer evaluation, and financial or grants management issues:
1. Scientific/Research Contact(s):
Richard Aragon, Ph.D.
Office of the Director
Countrywide 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)
Nationwide 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)
Nationwide 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)
National 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)
National 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 Research:
Recipients of PHS support for activities involving live, vertebrate animals need to comply with PHS Policy on Humane Care and Use of Laboratory Animals ( as mandated through the Well being Analysis 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 study to the subjects and others, and the importance of your knowledge gained or to get 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 relevant 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 wellbeing and disease by way 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 apps, regardless of 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 appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed through 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 critical research resources including the sharing of model organisms for biomedical investigation (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 utilizing 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 become included in all applications where the advancement of model organisms is anticipated.
Access to Analysis Data via the Freedom of Data Act:
The Office of Management and Finances (OMB) Circular A-110 has long been revised to provide access to research data through the Freedom of Data 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 by way of FOIA. It is essential 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 possibility in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description from the archiving plan within the study design and include data about this inside the spending budget justification section of 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 Analysis:
It is the policy of the NIH that women and members of minority groups and their sub-populations has to be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the wellbeing with the subjects or the goal from the analysis. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research ( a comprehensive copy of the up-to-date Guidelines is available at The amended policy incorporates: the use of an NIH definition of clinical research; 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 up-to-date 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 suitable, by ######/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Study:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical analysis, conducted or supported through the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing study 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 apps for analysis involving human subjects and individuals designated as key personnel. The policy is available at
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of investigation on hESCs can be found at and at Only study using hESC lines that are registered inside the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( It is the responsibility with the applicant to provide inside the project description and elsewhere within the application as acceptable, the official NIH identifier(s) for the hESC line(s) to be used within the proposed investigation.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded from the NIH must submit or have submitted for them to the Nationwide Library of Medicines PubMed Central (see an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to get 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 Wellbeing Details:
The Department of Well being and Human Solutions (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable wellbeing data, and is administered and enforced from the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation from the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a comprehensive 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 assessment, funding, and progress monitoring of grants, cooperative agreements, and study contracts can be found at
URLs in NIH Grant Applications or Appendices:
All purposes and proposals for NIH funding should 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 number citation may be repeated in each of these sections as proper. There is no limit to the quantity of URLs or PMC submission identification numbers that can be cited.
Healthy People 2010:
The Public Wellbeing Service (PHS) is committed to achieving the wellbeing promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is relevant to one or more from the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at
Authority and Regulations:
This method is described within the Catalog of Federal Domestic Guidance at and is not subject to the intergovernmental review needs 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 Component 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described within 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, health care,
Office 2007 Professional, or early childhood improvement services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a study career involving clinical, pediatric, contraception, infertility, and health disparities relevant areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a study career unfettered from the burden of student loan debt. Observe that an NIH grant is not required for eligibility and concurrent career award and LRP applications 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 should 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 info, please see:
Office 2007 Professional RFA-CA-10-002 Validation
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