Part I Overview Details
Department of Health and Human Providers
Participating Organizations
National Cancer Institute (NCI), (
Title: Validation and Innovative Growth of Emerging Technologies in Biospecimen Science (R33)
Announcement Variety
This Funding Option Announcement (FOA) can be a reissue of RFA-CA-09-005.
Update: The subsequent update referring to this announcement has become issued:
August sixteen, 2010 - Essential Notice! NIH has eradicated the error correction window for because of dates of January twenty five, 2011 and outside of. As of January 25, all corrections must be total by the because of date for an application to become considered on-time. See NOT-OD-10-123. February 19, 2010 - See Discover NOT-CA-10-018 The objective of this Discover is always to make clear the Price range Type . January 6, 2010 - This FOA has become updated to mirror the brand new demands from NIH’s Enhancing Peer Critique Initiative. The brand new requirements are successful for submissions meant for due dates January 25, 2010 and past. If submitting an application meant for a because of date of January twenty five, 2010 and beyond, stick to the advice under and be certain to use the Adobe-Forms-B model of the application varieties and recommendations. If applying for the due date ahead of January twenty five, 2010, follow the advice within the archived edition of this FOA and make sure to work with the Adobe-Forms-A version of the application varieties and recommendations. October 26, 2009 - See Recognize NOT-CA-10-005 Selection of Acceptable Funding Chance Announcements (FOAs) for that Continuation from the Progressive Technologies for Molecular Evaluation of Cancer (IMAT) Method .
Request for Apps (RFA) Range: RFA-CA-10-002
NOTICE: Purposes submitted in response to this Funding Opportunity Announcement (FOA) for Federal help have to be submitted electronically by way of Grants.gov ( using the SF424 Analysis and Relevant (R&R) kinds 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 Guidance 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 applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (with the applicant institution/organization)
Application Due 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 Review Date(s): October 2010; January 2011; May 2011
Earliest Anticipated Start Date(s): December 2010; April 2011; July 2011
Additional Details For being 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 Chance Announcement (FOA), issued by the Countrywide Cancer Institute (NCI), Nationwide Institutes of Wellbeing (NIH), solicits grant programs proposing technically innovative feasibility studies focused on the sophisticated development and validation of cancer-relevant technologies that address the issues related to pre-analytical variations in 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 advancement 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 programs; 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 inside 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 opportunity is aspect of a broader NCI-sponsored Modern Molecular Evaluation 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 applications under the NIH Exploratory/Developmental R21 grant mechanism. Funds Available and Anticipated Number 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. Spending budget and Project Period. An applicant for an R33 grant may request a project period of up to 3 years with a budget suitable to the science proposed. Direct costs cannot exceed $300,000 for any given year. Application Research Strategy Length: The R33 software Study Strategy section of your 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 study 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. Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the software. Number of Purposes. Applicants may submit more than one application, provided each application is scientifically distinct. Resubmissions. Applicants may submit a resubmission application, but such software must include an Introduction addressing the previous peer evaluation 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) programs will not be accepted. Special Date(s). This FOA uses non-standard because of dates. See Receipt, Assessment and Anticipated Start Dates. Software Materials. See Section IV.1 for software materials. All programs, including resubmission, revision and renewal, submitted for due dates January twenty five, 2010 and beyond, need to utilize the most current varieties and guidelines. General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites: SF424 (R&R) Application and Electronic Submission Details: General information on Electronic Submission of Grant Programs: Hearing Impaired. Telecommunications for the 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. Analysis 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. Software and Submission Details
1. Request Software Info
2. Content and Form of Software Submission
3. Submission Dates and Times
A. Receipt, Review, 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 Requirements
Section V. Application Assessment Info
1. Criteria
2. Review and Variety Process
A. Additional Evaluation Criteria
B. Additional Critique Considerations
C. Resource Sharing Plan
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Info
1. Award Notices
2. Administrative and National Policy Specifications
3. Reporting
Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Details - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose
This Funding Option Announcement (FOA) solicits grant programs proposing investigation projects focused on the advanced growth and validation of revolutionary transformative cancer-relevant technologies aimed at maximizing the quality and utility of samples and/or biospecimens used for biomedical analysis and medicine. The thrust of effort from the projects proposed in response to this FOA has to be on the innovative improvement of a technology, rather than on its initial inception and pilot stage growth. In this FOA, the Nationwide Cancer Institute (NCI) solicits grant purposes proposing investigation projects focused on the improvement of novel rising technologies addressing various aspects from the 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 analysis into cancer biology, treatment and diagnosis, prevention, control and epidemiology, and/or cancer well being disparities. Applicants are referred to the NCI Office of Biorepositories and Biospecimen Science (OBBR, for the better understanding of the current technology needs within 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 by the NCI Center to Reduce Cancer Well being Disparities (
Investigators interested in developing modern and/or emerging cancer technologies that are not relevant to the biospecimen sciences should consider applying to related FOAs that are portion of a broader NCI-sponsored Modern Molecular Analysis Technologies (IMAT, Program.
This FOA utilizes the R33 award mechanism for projects proposing the sophisticated growth of an emerging technology. The R33 mechanism is suitable for technology projects that are at the latter stages of growth, where technical feasibility has been demonstrated but lack validation within context of its intended use or proposed software. 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 the most novel and highly modern technologies in support of cancer study 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 with the subsequent three related themes:
1. Progressive Technology Advancement for Cancer Research (RFA-CA-10-005), which emphasizes technology development projects that are centered on the inception and preliminary development of very early stage, highly innovative, high impact technologies for cancer research;
2. Emerging Technology Growth for Cancer Study (RFA-CA-10-003, RFA-CA-10-004), which supports research projects on the initial application or use of rising, 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 advancement and validation of novel technologies to assess, evaluate, and interrogate biospecimens, or analytes thereof, in order to maximize their quality and utility in cancer analysis.
For more info about the IMAT method, a summary from the suite of FOAs, and links to those FOAs, prospective applicants should consult the IMAT website:
Specific Study Objectives and Scope of this FOA
The main emphasis of this FOA is on the validation and sophisticated advancement of a novel technology to advance the biospecimen sciences, rather than the initial technical advancement and inception. Projects proposed in response to this FOA must be pertinent to its overarching objective, i.e., applicants need to address the growth of technologies and methodologies that maximize the quality and utility of biospecimens and/or derived samples for cancer analysis and medicine. Projects proposed should be revolutionary rather than evolutionary; the conceived technologies should have the potential to dramatically alter the way that study can be pursued.
Responsive technologies encompass relevant techniques, tools, instrumentation, devices, 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 sophisticated development of novel technologies that can overcome these challenges when directly implemented on the analysis of biospecimens. Proposed projects must 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 growth and/or utilization of methods and/or technologies to assess the qualities of biospecimens or samples are also proper to this FOA.
These technologies may be supposed for molecular and cellular analyses in-vitro, in-situ, in-silico and/or in-vivo (with some exceptions), and may be targeted for your needs of basic, translational, epidemiology, clinical cancer research and/or aim to reduce cancer-related wellbeing 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 software 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 applications proposing to develop new technologies for cancer biospecimen preparations adhere to the guidelines outlined in the NCI Best Practices for Biospecimen Resources, which can be found at
Applicants responding to this FOA ought to meet the subsequent general needs (for details see Section IV.6. Other Submission Requirements and Info; Additional Application Guidelines):
The application is focused on the validation and sophisticated advancement of an progressive technology and has demonstrated limited feasibility, which may or may not be in context of its meant use or software. The proposed technology may be targeted for the 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, ought to offer the potential for substantial improvements over conventional approaches and/or add qualitatively new research capabilities not provided by current technologies. The software must clearly define the novelty of your 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. Purposes proposing any from the following will be returned to the applicant as non-responsive without review.
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 study); Projects that propose to make use of 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 development, 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 development of specific contrast agents; Projects focused on development of specific drugs or therapies.
Researchers focusing on hypothesis-based biospecimen analysis should consider one with the opportunities from the NCI Office of Biorepositories and Biospecimen Research (
Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software solutions should consider one with the Biomedical Info 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 Plan (CIP, for info 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 connected IMAT FOA RFA-CA-10-001. Applicants considering projects on rising technologies whose supposed use does not address biospecimen/sample quality should consider connected IMAT FOAs RFA-CA-10-003 and RFA-CA-10-004.
Researchers who are unclear as to which with the IMAT FOAs might be most proper for their proposed technology growth project are encouraged to contact the system official listed in this FOA.
Attributes from the NIH R33 Mechanisms within the IMAT context. The R33 mechanism is meant to support the advanced stages of technology growth for those projects in which feasibility has been demonstrated, but not in context of its intended use or software. Proposed projects are expected to become novel and may involve considerable risk, but may lead to a breakthrough in a particular area that could have a major impact on cancer analysis. To get comprehensive and responsive to IMATs R33 FOAs, all apps 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 Info - Required Federal Citations, for policies connected 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 information concepts (see SF424 (R&R) Software Guide). It also uses the modular as well as the non-modular price range formats (see Specifically, a U.S. organization submitting an application with direct costs in each year of $300,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should utilize the PHS398 Modular Spending budget component.
All foreign applicants must comprehensive and submit budget requests using the Investigation & Associated 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 proper for your science proposed and direct costs cannot exceed $300,000 for any given year.
Because the nature and scope of your proposed analysis 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 opportunity are contingent upon the availability of funds.
Facilities and Administrative (F&A) costs requested by consortium participants are not included from the direct cost limitation. See NOT-OD-05-004.
NIH grants policies as described within 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 following 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,
Windows 7 Home Premium, knowledge, and resources necessary to carry out the proposed analysis as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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 data on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at All PDs/PIs have to be registered inside the NIH electronic Study Administration (eRA) Commons prior to the submission of the software (see for recommendations).
The decision of whether to apply for any grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of your investigators and applicant organizations and should be determined from the scientific goals of your project. Programs for grants with multiple PDs/PIs will require additional information, as outlined from the recommendations 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 with the individual PDs/PIs will be factored into the assessment of your overall scientific merit with 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 your proper conduct with the project or plan, including the submission of required reports. For further information on multiple PDs/PIs, please see
2. Cost Sharing or Matching
This plan does not require cost sharing as defined within the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number of Programs. Applicants may submit more than one software, provided each application 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 programs supposed for that January 25, 2009 official submission because of date, all original new purposes (i.e., never submitted) and competing renewal purposes will be permitted only a single amendment (A1). See and NOT-OD-09-016. Original new and competing renewal programs that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 programs after that date.
Renewals. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) purposes will not be accepted.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application 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) Application Package and SF424 (R&R) Software Guide for completing the SF424 (R&R) kinds 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.
Registration:
Appropriate registrations with Grants.gov and eRA Commons have to be completed on or ahead of the due date in order to successfully submit an software. Several with the 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 full through the submission deadline for the software to be considered on-time (see 3.C.1 for more info 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 certain they are registered from the NIH eRA Commons.
Several additional separate actions are required prior to 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 Quantity System (DUNS) amount and register with the Central Contractor Registration (CCR) as component of the Grants.gov registration process. If your organization does not have a Taxpayer Identification Quantity (TIN) or Employer Identification Number (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 within 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 within the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
The individual designated as the PD/PI on the application need to also be registered within 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 in 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 have to be done through the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered from the Commons. Both the PD/PI and AOR/SO need separate accounts in 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 quantity. Only one DUNS quantity is required and the same DUNS amount should be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) types.
1. Request Software Information
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 types package directly attached to a specific FOA can be used. You will not be able to work with any other SF424 (R&R) varieties (e.g., sample forms, varieties from another FOA), although some of your "Attachment" files may be useable for more than one FOA.
For further assistance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY: (301) 451-5936
2. Content and Sort of Application Submission
Prepare all programs utilizing the SF424 (R&R) application kinds and in accordance with the SF424 (R&R) Software Guide for this FOA by means of Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a total and accurate software to NIH. Some fields within the SF424 (R&R) software components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of your Study & Related Senior/Key Person Profile component ought to contain the PD/PIs assigned eRA Commons User ID). Agency-specific recommendations for such fields are clearly identified from the Application Guide. For additional info, see Frequently Asked Questions Software Guide, Electronic Submission of Grant Applications.
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 from the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Relevant Other Project Details
Research & Relevant Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Analysis & Connected Finances, as suitable (See Section IV.6., Special Directions, regarding acceptable required price range component.)
Optional Components:
PHS398 Cover Letter File
Research & Connected Subaward Spending 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 in the NIH Grants Policy Statement at:
Applications from Foreign organizations should:
Request budgets in U.S. dollars; Prepare detailed budgets for all programs (that is, total the Research & Associated Price range component of the SF424 (R&R) software kinds not the PHS398 Modular Finances 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 acceptable, 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 by means of the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.
SPECIAL Directions
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI for being 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 beneath, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility needs for PD/PI status inside 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 your Contact PD/PI should be entered in item 15 of your SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Analysis & Relevant Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs should be registered inside the eRA Commons prior to software submission. The Commons ID of each PD/PI should be included from the Credential field with the Study & Related 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 that proposed project.
Multiple PD/PI Leadership Plan: For apps designating multiple PDs/PIs, a new section of your Analysis Plan, entitled Multiple PD/PI Leadership Plan, must 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 that project or method 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 from the Leadership Plan. From the event of an award, 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 within the SF424 (R&R) Software 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 by the prime institution. When submitting a detailed spending budget, the prime institution should submit its spending budget using the Study & Associated Finances component. All other institutions should have their individual budgets attached separately to the Analysis & Associated Subaward Budget Attachment(s) Sort. See Section 4.8 with the SF424 (R&R) Application Guide for further instruction regarding the use of your subaward budget kind.
When submitting a modular spending budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract spending budget is provided inside the finances justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular spending budget format. See Section 5.4 of your Software Guide for further instruction regarding the use of your PHS398 Modular Spending budget component.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
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, 2010
NOTE: On-time submission requires that apps be successfully submitted to Grants.gov no later than 5:00 p.m. local time (with the applicant institution/organization).
Application Due 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 Review 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 data:
Descriptive title of proposed analysis. Name, address, and telephone amount from the PD(s)/PI(s). Names of other key personnel. Collaborating institutions. Quantity and title of this funding possibility.
Although a letter of intent is not required, is not binding, and does not enter into the evaluation of a subsequent software, the info that it contains allows IC staff to estimate the potential critique workload and plan the critique.
The letter of intent would be to be sent from 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 comply with Steps 1-4. Note: Programs need to only be submitted electronically.
PAPER Purposes WILL NOT BE ACCEPTED.
In order to expedite the critique, 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 range and title, PD/PI name, and title of your application.
3.C. Application Processing
3.C.1 Submitting On-Time
Applications may be submitted on or after the opening date and should be successfully received by Grants.gov no later than 5:00 p.m. local time (of your applicant institution/organization) on the application because of date(s). (See Section IV.3.A. for all dates.) If an application is not submitted through the due date(s) and time, the software may be delayed inside the critique process or not reviewed. All apps should meet the following criteria to become deemed on-time:
All registrations must be full prior to the submission deadline The application must receive a Grants.gov tracking amount 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 data 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 ought to stick to their software by way of 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
Critical Note! NIH has eradicated the error correction window for due dates of January twenty five, 2011 and beyond. As of January 25, all corrections have to be total from the due date for an software for being deemed on-time. See NOT-OD-10-123.
Once an software package has long been successfully submitted via Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before 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 has to be corrected to successfully total the submission process. Warnings will not prevent the software from completing the submission process.
Please notice that the following caveats apply:
Initial software submission should be on-time. The AOR/institutions is expected to enforce that software 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 range) and description of all changes made within the window must be documented within the PHS 398 Cover Letter component of your software.
3.C.3 Viewing an Software in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application continues to be created inside 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 application just before 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 Assessment for processing after two weekdays, excluding Federal holidays. Prior to the submission deadline, the AOR/SO can Reject the assembled software 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 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 apps. The Reject feature should also be used if you determine that warnings are applicable to your application 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 for being addressed later from the process. If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the software if, due to an eRA Commons or Grants.gov system issue,
Windows 7 Starter, the application does not correctly mirror the submitted application package (e.g., some aspect from the 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 for the 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 in 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 inside the process after two weekdays.
Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive apps 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. Details connected to the assignment of an application to a Scientific Critique Group is also within the Commons.
Note: Since email can be unreliable, it is the responsibility of your applicant to check periodically on the application status within the Commons.
The NIH will not accept any software in response to this FOA that is essentially the same as one currently pending initial merit evaluation unless the applicant withdraws the pending application. The NIH will not accept any software that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application should include an Introduction addressing the critique from the previous assessment.
4. Intergovernmental Critique
This initiative is not subject to intergovernmental critique.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described from 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 ahead of the beginning date with 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 must obtain NIH approval ahead of incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days just before the beginning date with the initial finances 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 with the 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 for being 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 inside the approved time frame or in any way adversely affect the conduct of the project (see the NIH Grants Policy Statement).
6. Other Submission Needs
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 spending budget. For that purposes of estimating budgets - plan on a 2-day meeting each year, with the location alternating between the east and west coasts from 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 from the PROFILE Project Director/Principal Investigator section, Credential log-in field with the Analysis & Connected Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile within 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 software recommendations outlined inside the SF424 (R&R) Software Guide are for being followed, incorporating "Just-in-Time" data concepts, and with the subsequent needs for R33 purposes:
The non-modular, detailed finances format is to be used irrespective of your requested spending budget amount; in other words, the solicited R33 purposes should not utilize the NIH modular spending budget format. The Research 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 component with the software. Renewal (formerly competing continuation or Kind 2) applications are not permitted.
Other Specific Directions for Preparation of an R33 Application
R33 applicants need to present detailed preliminary data in support with the feasibility with the proposed technology or approach that is proposed for advancement. Whereas R33 applications by definition ought to deal with technologies that are over and above the inception stage, applicants ought to demonstrate the innovation of 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 Analysis Strategy Section of all R33 purposes.
Preliminary Studies/Progress Report. This section ought to document the feasibility of 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. In the event that an applicant feels that the underlying technology is too proprietary to disclose, the applicant should at a minimum provide a demonstration (results) of the capabilities of your 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 investigation begun under R21 support: the Study Strategy attachment ought to quote the final Milestones from the R21 Recognize 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 Directions:
In the Significance section from the Analysis Plan, the applicant need to provide (under a separate sub-heading) a short narrative on the innovation and potentially transformative nature of the technology. The following questions should be addressed:
How is the technology potentially transformative and why may it be expected to produce an unusually high impact on biomedical research? 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 Demands. An annual meeting of all investigators funded by way of this system will be held to share progress and study insights that may lead to further progress from the system. Within the budgets, applicants must 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 from the results of such investigation 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 connected inventions to an invention management firm; (2) designating one organization to take the lead on patenting and licensing relevant 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 from 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 thought to be. Intellectual property management plans are a just-in-time requirement and do not need to get included in the grant software but will be required prior to 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 from the exclusive license is restricted to commercial use; or (2) the exclusive licensee will make the study tool available on reasonable terms. Applicants are directed to the NIH policy on the dissemination of biological analysis resources (research tools) at
Appendix Materials
Applicants ought to comply with the specific directions 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 in the assessment process.
Resource Sharing Plan(s)
NIH considers the sharing of unique analysis resources developed via NIH-sponsored analysis an important means to enhance the value and further the advancement from the investigation. When resources have been developed with NIH funds and the associated study findings published or provided to NIH, it is crucial that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this has to be explained inside the Resource Sharing section of your software (see
(a) Data Sharing Plan: Regardless of your amount requested, investigators are expected to include a brief 1-paragraph description of how final study data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH method contact (see Data-Sharing Policy or
(b) Sharing Model Organisms: Regardless of the amount requested, all applications 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 acceptable 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 your 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 appropriate 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 of the NIH/IC and has the potential for significantly advancing the well being sciences from the United States.
Section V. Application Critique Information
1. Criteria
Only the evaluation criteria described below will be regarded as in the assessment process.
2. Review and Assortment Process
Review Process
Applications that are comprehensive and responsive to this FOA will be evaluated for scientific and technical merit by an acceptable peer review group convened by the Nationwide Cancer Institute and in accordance with NIH peer assessment procedures ( making use of the assessment criteria stated below.
As component with the scientific peer evaluation, all apps will:
Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of apps under review, will be discussed and assigned a rating; Receive a written critique; and Receive a second level of evaluation by the National Cancer Advisory Board
Because the Research Strategy component is limited to 12 pages, an exploratory/developmental grant software need not have extensive background material or preliminary info as one might normally expect in an R01 application. 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. Acceptable 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 of your 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, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact. Reviewers will provide an overall impact/priority score to replicate their assessment of your likelihood for that project to exert a sustained, powerful influence on the analysis field(s) involved, in consideration of your subsequent five core evaluation criteria, and additional evaluation criteria (as applicable for your project proposed).
Core Evaluation Criteria. Reviewers will consider each of your five evaluation criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to become strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not progressive may be essential to advance a field.
Significance. Does the project address an essential problem or a critical barrier to progress in the field? If the aims of your 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, solutions, 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 suitable 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 proper for that project?
Innovation. Does the software challenge and seek to shift current investigation 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? Is 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 suitable to accomplish the specific aims with the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is from the early stages of development, 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 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 research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for that project proposed? Will the project benefit from unique features of your scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the subsequent additional items inside 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 of your six categories of research that are exempt under 45 CFR Portion 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from investigation risk relating to their participation according to the following five assessment criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance from the knowledge for being gained, and 5) data and safety monitoring for clinical trials.
For analysis that involves human subjects and meets the criteria for one or more of your six categories of investigation that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for your 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 with the scientific assessment according to the following five points: 1) proposed use of your animals, and species, strains, ages, ######, and numbers for being used; 2) justifications for that use of animals and for that 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 inside 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 Purposes. When reviewing a Resubmission software (formerly called an amended application), the committee will evaluate the application 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 application (formerly called a competing supplement application), the committee will consider the appropriateness with the proposed expansion with the scope with the project. If the Revision application 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 study personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Critique Considerations
As applicable for the project proposed, reviewers will address each with 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 Investigation. Reviewers will assess the information provided in this section from the application, including 1) the Select Agent(s) for being used within 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),
Buy Office 2007, and 4) plans for suitable biosafety, biocontainment, and security of the Select Agent(s).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering investigation programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available from 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 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 following will be deemed in making funding decisions:
Scientific merit with the proposed project as determined by peer review. Availability of funds. Relevance with the 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 critique with the 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" details from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Component II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
A formal notification from the type of a Discover of Award (NoA) will be provided to the applicant organization. The NoA signed through 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 just before 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 Countrywide Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as component from the NoA. For these terms of award, see the NIH Grants Policy Statement Aspect II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Aspect 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 chance and welcome the possibility to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (system), 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)
National 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)
Countrywide 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 Critique Contact(s):
Referral Officer
Division of Extramural Activities
National Cancer Institute (NCI)
6116 Executive Blvd,
Microsoft Office Home And Business, 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 Wellbeing 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 has to be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits from the study to the subjects and others, and the importance of the 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 advice from their institutions, on issues relevant to institutional policies and local institutional evaluation 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 health 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 your 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 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 application or contract proposal are expected to include from the application/proposal a description of a specific plan for sharing and distributing unique model organism analysis 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 become included in all applications where the growth of model organisms is anticipated.
Access to Analysis Data via the Freedom of Details Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to analysis data through 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 by means of FOIA. It is crucial 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 option 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 with the archiving plan from the study design and include info about this from the spending budget justification section of the application. 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 Study:
It is the policy with the NIH that women and members of minority groups and their sub-populations has to be included in all NIH-supported clinical study projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the wellness of your subjects or the objective 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 Study ( a total copy with the up-to-date Guidelines is available at The amended policy incorporates: the use of an NIH definition of clinical study; 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) software; 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 applications or proposals and/or protocols need 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 need to report annual accrual and progress in conducting analyses, as proper, 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) have to be included in all clinical study, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research 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 applications for study involving human subjects and individuals designated as key personnel. The policy is available at
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at and at Only analysis 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 the applicant to provide within the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to become used from the proposed investigation.
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 National Library of Medicines PubMed Central (see an electronic version 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 data, see the Public Access webpage at
Standards for Privacy of Individually Identifiable Well being Info:
The Department of Wellbeing and Human Solutions (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Wellness Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is really a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable well being info, and is administered and enforced by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of your Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides data on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Info on the impact from the HIPAA Privacy Rule on NIH processes involving the critique, funding, and progress monitoring of grants, cooperative agreements, and investigation contracts can be found at
URLs in NIH Grant Programs or Appendices:
All apps and proposals for NIH funding has to be self-contained within specified page limitations. For publications listed in 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,
Office Professional, the Progress Report Publication List section, or the Biographical Sketch section with the NIH grant software. A URL or PMC submission identification range citation may be repeated in each of these sections as proper. There is no limit to the range of URLs or PMC submission identification numbers that can be cited.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is associated to one or more of your priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at
Authority and Regulations:
This system is described from the Catalog of Federal Domestic Assistance 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 Wellness Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described from 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, 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 with the American people.
Loan Repayment Programs:
NIH encourages programs for educational loan repayment from qualified wellness professionals who have made a commitment to pursue a study career involving clinical, pediatric, contraception, infertility, and health disparities connected 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 by the burden of student loan debt. Notice 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 ought 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 analysis. For further info, please see:
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