Cheap Office Professional Plus 2010 RFA-CA-10-002

Part I Overview Data

Department of Well being and Human Solutions
Participating Organizations
National Cancer Institute (NCI), (

Title: Validation and Advanced Improvement of Emerging Technologies in Biospecimen Science (R33)

Announcement Sort
This Funding Option Announcement (FOA) is really a reissue of RFA-CA-09-005.

Update: The subsequent update relating to this announcement has long been issued:
August 16, 2010 - Crucial Observe! NIH has eradicated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections have to be full by the due date for an application to become thought to be on-time. See NOT-OD-10-123. February 19, 2010 - See Observe NOT-CA-10-018 The purpose of this Observe would be to clarify the Spending budget Form . January six, 2010 - This FOA has long been up-to-date to replicate the brand new demands from NIH’s Enhancing Peer Review Initiative. The new requirements are powerful for submissions supposed for because of dates January twenty five, 2010 and over and above. If submitting an software supposed for the because of date of January 25, 2010 and beyond, follow the guidance beneath and be certain to make use of the Adobe-Forms-B version with the application types and instructions. If applying for any due date before January twenty five, 2010, comply with the guidance in the archived edition of this FOA and make sure to make use of the Adobe-Forms-A version with the application varieties and directions. October 26, 2009 - See Observe NOT-CA-10-005 Variety of Proper Funding Chance Announcements (FOAs) for the Continuation of the Progressive Technologies for Molecular Evaluation of Cancer (IMAT) System .
Request for Programs (RFA) Quantity: RFA-CA-10-002

NOTICE: Programs submitted in response to this Funding Chance Announcement (FOA) for Federal support must be submitted electronically through Grants.gov ( utilizing the SF424 Research and Connected (R&R) varieties and the SF424 (R&R) Software Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA should 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 Number(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 purposes be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of your applicant institution/organization)
Application Because of Date(s): February 23, 2010; May 27, 2010; September 30, 2010
Peer Evaluation 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
Function. This Funding Opportunity Announcement (FOA), issued through the Countrywide Cancer Institute (NCI), Countrywide Institutes of Health (NIH), solicits grant applications proposing technically revolutionary feasibility studies focused on the innovative improvement and validation of cancer-relevant technologies that address the issues relevant to pre-analytical variations within the collection, processing, handling, and storage of biospecimens or its derivatives. The overall goal is to develop technologies capable of interrogating and/or maximizing the quality and utility of biospecimens or their derived samples for downstream molecular analyses. This FOA will support the 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 applications; this mechanism is suitable for projects where proof-of-principle from the proposed technology or methodology has already been established and supportive preliminary data are available. Projects proposing to utilize 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 chance is portion of a broader NCI-sponsored Modern Molecular Evaluation Technologies (IMAT) Method. 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 purposes 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. Finances and Project Period. An applicant for an R33 grant may request a project period of up to 3 years with a price range appropriate to the science proposed. Direct costs cannot exceed $300,000 for any given year. Software Research Strategy Length: The R33 software 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 study are invited to work with their institution/ organization to develop an software for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Quantity of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the software. Quantity of Apps. Applicants may submit more than one software, provided each software is scientifically distinct. Resubmissions. Applicants may submit a resubmission software, but such software must include an Introduction addressing the previous peer assessment critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Renewals. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) programs will not be accepted. Special Date(s). This FOA uses non-standard due dates. See Receipt, Assessment and Anticipated Start Dates. Application Materials. See Section IV.1 for software materials. All apps, including resubmission, revision and renewal, submitted for due dates January twenty five, 2010 and past, must utilize the most current types and directions. General Info. For general details on SF424 (R&R) Software and Electronic Submission, see these Web sites: SF424 (R&R) Application and Electronic Submission Information: General info on Electronic Submission of Grant Applications: 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 Chance Description
1. Analysis Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Details
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 Details
2. Content and Sort of Application Submission
3. Submission Dates and Times
A. Receipt, Evaluation, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Software Electronically to the NIH
C. Application Processing
4. Intergovernmental Evaluation
5. Funding Restrictions
6. Other Submission Demands
Section V. Software Assessment Info
1. Criteria
2. Evaluation and Selection Process
A. Additional Assessment Criteria
B. Additional Evaluation Considerations
C. Resource Sharing Plan
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and Countrywide Policy Demands
3. Reporting
Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Assessment Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement

Section I. Funding Possibility Description

1. Investigation Objectives
Purpose

This Funding Possibility Announcement (FOA) solicits grant apps proposing study projects focused on the superior advancement and validation of modern 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 inside 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 advancement. In this FOA, the National Cancer Institute (NCI) solicits grant purposes proposing study projects focused on the advancement of novel emerging technologies addressing various aspects of 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 study into cancer biology, treatment and diagnosis, prevention, control and epidemiology, and/or cancer health disparities. Applicants are referred to the NCI Office of Biorepositories and Biospecimen Science (OBBR, for the better understanding of your current technology needs in 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 Wellness Disparities (

Investigators interested in developing progressive and/or emerging cancer technologies that are not relevant to the biospecimen sciences should consider applying to related FOAs that are part of a broader NCI-sponsored Modern Molecular Evaluation Technologies (IMAT, Plan.

This FOA utilizes the R33 award mechanism for projects proposing the innovative improvement of an rising technology. The R33 mechanism is suitable for technology projects that are at the latter stages of advancement, where technical feasibility continues to be demonstrated but lack validation within context of its meant use or proposed software. Feasibility (proof-of-concept) data are required for this FOA.

The IMAT Program

Since its inception in 1998, the IMAT Method ( has focused on stimulating and accelerating the improvement, integration, maturation, and dissemination of the most novel and highly revolutionary technologies in support of cancer research and medicine. Together with the NCIs other technology intensive programs, IMAT continues to generate the tools and methods that enable cancer researchers to make new discoveries, enhance the knowledge-base, generate new and improved detection, develop diagnostic methods and treatment strategies, conduct large population studies, and assist in clinical decision making.

The IMAT Method consists from the subsequent three associated themes:

1. Revolutionary Technology Improvement for Cancer Study (RFA-CA-10-005), which emphasizes technology development projects that are centered on the inception and preliminary improvement of very early stage, highly revolutionary, high impact technologies for cancer research;

2. Emerging Technology Development for Cancer Research (RFA-CA-10-003, RFA-CA-10-004), which supports research projects on the initial software or use of emerging, transformative technologies in a biological context relevant to the meant use of the technology; and

3. Innovative and Applied Rising 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 analysis.

For more data about the IMAT method, a summary from the 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 superior growth of a novel technology to advance the biospecimen sciences, rather than the initial technical improvement and inception. Projects proposed in response to this FOA should be pertinent to its overarching objective, i.e., applicants must address the improvement 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 analysis 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 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 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 innovative growth 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 research and/or for clinical use. The development and/or utilization of methods and/or technologies to assess the qualities of biospecimens or samples are also acceptable 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 the needs of basic, translational, epidemiology, clinical cancer investigation and/or aim to reduce cancer-related health disparities within the biospecimen/sample preparation context. Responsive technologies should advance the biospecimen sciences and/or sample preparation methodologies. Projects focused on the growth 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 inside 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.six. Other Submission Requirements and Info; Additional Software Instructions):
The application is focused on the validation and advanced growth of an innovative technology and has demonstrated limited feasibility, which may or may not be in context of its meant use or application. The proposed technology may be targeted for your biospecimen/sample preparation needs of basic, preventative, diagnostic, translational, epidemiology, and/or clinical cancer study 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 application must clearly define the novelty from the proposed technology and describe its anticipated use in a investigation laboratory and/or a clinical setting.
The subsequent aspects/characteristics remain outside the scope of IMAT and this FOA. Purposes proposing any from the subsequent will be returned to the applicant as non-responsive without critique.
Projects focused on the elucidation from 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 work with 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 growth 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 improvement of specific drugs or therapies.
Researchers focusing on hypothesis-based biospecimen study should consider one with the opportunities from the NCI Office of Biorepositories and Biospecimen Study (

Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software solutions should consider one from the 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 suitable funding opportunities.

Related IMAT FOAs: Applicants considering projects focused on innovative technologies that are in its earliest stages of advancement or inception should consider associated IMAT FOA RFA-CA-10-001. Applicants considering projects on emerging technologies whose supposed use does not address biospecimen/sample quality should consider associated IMAT FOAs RFA-CA-10-003 and RFA-CA-10-004.

Researchers who are unclear as to which from the IMAT FOAs might be most proper for their proposed technology advancement project are encouraged to contact the plan official listed in this FOA.

Attributes of the NIH R33 Mechanisms within the IMAT context. The R33 mechanism is meant to support the innovative stages of technology development for those projects in which feasibility has been demonstrated, but not in context of its supposed use or software. Proposed projects are expected to get novel and may involve considerable risk, but may lead to a breakthrough in a particular area that could have a major impact on cancer study. To get complete and responsive to IMATs R33 FOAs, all applications should include feasibility (proof-of-concept) data via prior research, which may or may not have been previously supported by an exploratory R21 grant.

The R33 project is expected to generate sufficient data to fully validate the technology in a biologically relevant setting and demonstrate its full utility in addressing the biospecimen sciences or sample preparation methodologies.

See Section VIII, Other Details - 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 info concepts (see SF424 (R&R) Application 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 use the PHS398 Modular Budget component.

All foreign applicants need to total and submit spending budget requests utilizing the Investigation & Related 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 the science proposed and direct costs cannot exceed $300,000 for any given year.
Because the nature and scope from 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 of the IC(s) provide support for this system, awards pursuant to this funding option are contingent upon the availability of funds.

Facilities and Administrative (F&A) costs requested by consortium participants are not included within the direct cost limitation. See NOT-OD-05-004.

NIH grants policies as described inside the NIH Grants Policy Statement will apply to the apps 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, knowledge, and resources necessary to carry out the proposed investigation 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 details on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual investigation projects is available at All PDs/PIs should be registered within the NIH electronic Research Administration (eRA) Commons prior to the submission from the software (see for instructions).

The decision of whether to apply for any grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the 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 data, as outlined from the instructions under. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience with the individual PDs/PIs will be factored into the assessment from 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 suitable, to a collaborating organization, for the proper conduct of your project or program, including the submission of required reports. For further information 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 Purposes. Applicants may submit more than one software, provided each software is scientifically distinct.

Resubmissions. Applicants may submit a resubmission application, but such application ought to include an Introduction addressing the previous peer assessment critique (Summary Statement). Beginning with applications supposed for the January twenty five, 2009 official submission due date, all original new programs (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 programs that were submitted prior to January twenty five, 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) apps will not be accepted.

Section IV. Software and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms 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) 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 comply with the directions provided on that Web site.
Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or prior to the due date in order to successfully submit an software. Several of 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 has to be complete through the submission deadline for that software to get considered 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 confident they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered
Your organization will need to obtain a Data Universal Amount System (DUNS) quantity and register with the Central Contractor Registration (CCR) as portion with the Grants.gov registration process. If your organization does not have a Taxpayer Identification Quantity (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 from 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 software must also be registered inside the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov. The PD/PI need to 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 must be done through the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Commons. Both the PD/PI and AOR/SO need separate accounts from 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 number is required and the same DUNS range have to be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) types.

1. Request Application Information
Applicants need to download the SF424 (R&R) application types and the SF424 (R&R) Application Guide for this FOA by means of Grants.gov/Apply.

Note: Only the kinds package directly attached to a specific FOA can be used. You will not be able to make use of any other SF424 (R&R) varieties (e.g., sample varieties, types from another FOA), although some from the "Attachment" files may be useable for more than one FOA.
For further support, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all programs making use of the SF424 (R&R) application kinds and in accordance with the SF424 (R&R) Application Guide for this FOA by way of Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a comprehensive and accurate application 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 from the Research & Relevant Senior/Key Person Profile component ought to contain the PD/PIs assigned eRA Commons User ID). Agency-specific directions for such fields are clearly identified from the Application Guide. For additional information, see Frequently Asked Questions Software Guide, Electronic Submission of Grant Purposes.

The SF424 (R&R) software has several components. Some components are required, others are optional. The kinds package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed software in response to this FOA includes the data within the subsequent components:

Required Components:
SF424 (R&R) (Cover component)
Research & Connected Project/Performance Site Locations
Research & Connected Other Project Details
Research & Connected Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Investigation Plan
PHS398 Checklist
PHS398 Modular Spending budget or Analysis & Related Spending budget, as acceptable (See Section IV.six., Special Directions, regarding acceptable required budget component.)

Optional Components:
PHS398 Cover Letter File
Research & Related 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 within the NIH Grants Policy Statement at:

Applications from Foreign organizations should:
Request budgets in U.S. dollars; Prepare detailed budgets for all applications (that is, complete the Research & Relevant Spending budget component of your SF424 (R&R) software varieties 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 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 Needs).
Proposed study should provide special opportunities for furthering investigation 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 Instructions

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 application materials outlined below, and for coordinating progress reports for your project. The contact PD/PI need to meet all eligibility specifications 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 the Contact PD/PI should be entered in item 15 of your SF424 (R&R) Cover component. All other PDs/PIs should be listed within the Analysis & Relevant 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 application submission. The Commons ID of each PD/PI have to be included within the Credential field with the Investigation & Relevant Senior/Key Person component. Failure to include this data field will cause the software to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for that proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section from the Research 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 of your 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 that project or system should be delineated for the PDs/PIs and other collaborators.

If price range allocation is planned, the distribution of resources to specific components from the project or the individual PDs/PIs should be delineated from the Leadership Plan. Within 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 guidelines contained within the SF424 (R&R) Software Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) have to be requested via a subcontract to be administered through the prime institution. When submitting a detailed price range, the prime institution should submit its finances making use of the Study & Associated Finances component. All other institutions should have their individual budgets attached separately to the Study & Associated Subaward Budget Attachment(s) Kind. See Section 4.8 of your SF424 (R&R) Software Guide for further instruction regarding the use of the subaward price range form.

When submitting a modular price range, the prime institution completes the PHS398 Modular Finances component only. Info concerning the consortium/subcontract finances is provided in the spending budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular price range format. See Section 5.4 of the Software Guide for further instruction regarding the use of your PHS398 Modular Budget component.

3. Submission Dates and Times
See Section IV.3.A. for details.

3.A. Submission, Assessment, 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 programs be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Because of Date(s): February 23, 2010; May 27, 2010; September 30, 2010
Peer Review Date(s): May/June 2010; August/September 2010; January/February 2011
Council Evaluation 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 following details:
Descriptive title of proposed study. Name, address, and telephone amount of 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 assessment of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the assessment.
The letter of intent would be to be sent by the date listed in Section IV.3.A.
The letter of intent should be sent to:
raragon@mail.nih.gov
3.B. Submitting an Software Electronically to the NIH
To submit an software in response to this FOA, applicants should access this FOA via and comply with Steps 1-4. Note: Apps need to only be submitted electronically.

PAPER Programs WILL NOT BE ACCEPTED.

In order to expedite the review, applicants are requested to notify the Nationwide Cancer Institutes Referral Office by email ncirefof@dea.nci.nih.gov when the application continues to be submitted. Please include the FOA range and title, PD/PI name, and title from the software.

3.C. Software Processing
3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and have to 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 by the due date(s) and time, the software may be delayed within the review process or not reviewed. All programs ought to meet the subsequent criteria to be thought to be on-time:
All registrations must be comprehensive prior to the submission deadline The software should receive a Grants.gov tracking range and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date. Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.
Please visit for detailed info on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step - applicants should follow their application by means 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

Crucial Observe! NIH has removed the error correction window for due dates of January 25, 2011 and past. As of January 25, all corrections should be comprehensive through the because of date for an software to be deemed on-time. See NOT-OD-10-123.

Once an software package has been 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,Office 2010 Home And Student Product Key, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors should be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the subsequent caveats apply:
Initial software submission have to be on-time. The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes. Proof of on-time submission (e.g., Grants.gov timestamp and tracking quantity) and description of all changes made within the window should be documented within the PHS 398 Cover Letter component with the software.
3.C.3 Viewing an Software in the eRA Commons

Once any eRA identified errors have been addressed and the assembled software 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 prior to it automatically moves forward to NIH for further processing.
If everything is acceptable, no further action is necessary. The software will automatically move forward to the Division of Receipt and Referral within the Center for Scientific Review for processing after two weekdays, excluding Federal holidays. Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some 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 software 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 adhere to the directions for correcting errors in Section 2.12, including the requirement for cover letters on late applications. 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 software 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 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, because of to an eRA Commons or Grants.gov system issue, the software does not correctly replicate the submitted software package (e.g., some component of the application was lost or did not transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue. If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected software still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained inside the cover letter attachment. Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the software automatically moves forward within the process after two weekdays.
Upon receipt, apps will be evaluated for completeness through the CSR and responsiveness from the IC. Incomplete and non-responsive purposes will not be reviewed.

There will be an acknowledgement of receipt of apps 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 application to a Scientific Critique Group is also from the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the software 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 review 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 software, but such software ought to include an Introduction addressing the critique from the previous evaluation.

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 within the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days ahead of the beginning date from the initial price range 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 ought to obtain NIH approval ahead of incurring the cost. NIH prior approval is required for any costs for being incurred more than 90 days prior to the beginning date of your initial 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 with the approved spending budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to get fully aware that pre-award costs result in borrowing against future support and that such borrowing need to not impair the grantee's ability to accomplish the project objectives from the approved time frame or in any way adversely affect the conduct with 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 from the Principal Investigator and one co-investigator to participate from the annual PI meeting should be included in the proposed price range. For that purposes of estimating budgets - plan on a 2-day meeting each year, with the location alternating between the east and west coasts of 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 with the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS range in its Organization Profile inside the eRA Commons. This DUNS amount need to match the DUNS range provided at CCR registration with Grants.gov. For additional info, see Frequently Asked Questions Software Guide, Electronic Submission of Grant Purposes.

PHS398 Investigation Plan Component Sections

All software recommendations outlined within the SF424 (R&R) Application Guide are for being followed, incorporating "Just-in-Time" details concepts, and with the following demands for R33 apps:
The non-modular, detailed finances format would be to be used irrespective of your requested spending budget amount; in other words, the solicited R33 applications should not utilize the NIH modular budget format. The Study Strategy may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. Introduction (required for any resubmission software) is limited to one page. Preliminary data are required as portion from the application. Renewal (formerly competing continuation or Variety 2) applications are not permitted.
Other Specific Directions for Preparation of an R33 Application

R33 applicants must present detailed preliminary data in support of your feasibility from the proposed technology or approach that is proposed for improvement. Whereas R33 purposes by definition need to deal with technologies that are past the inception stage, applicants must demonstrate the innovation with the particular technology or approach proposed for advancement within 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 notice that there is really a strict 12-page limit for that Research Strategy Section of all R33 purposes.

Preliminary Studies/Progress Report. This section ought to document the feasibility of your 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 become 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 study begun under R21 support: the Investigation Strategy attachment should quote the final Milestones from the R21 Notice 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 with the Analysis Plan, the applicant ought to provide (under a separate sub-heading) a short narrative on the innovation and potentially transformative nature with 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 Needs. An annual meeting of all investigators funded through this program will be held to share progress and analysis insights that may lead to further progress in the method. From the budgets, applicants ought to include travel expenses for that PD/PI and one additional senior investigator to attend this annual meeting.

Intellectual Property Management

Certain research 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 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 need 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 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 of your 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 deemed. Intellectual property management plans are a just-in-time requirement and do not need to become included in the grant application but will be required before an R33 grant can be awarded.

The applicant's institution should avoid exclusively licensing those inventions that are investigation tools unless either: (1) the field of use of 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 investigation resources (analysis tools) at

Appendix Materials

Applicants should stick to the specific recommendations on Appendix materials as described inside the SF424 (R&R) Application 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 within the assessment process.
Resource Sharing Plan(s)
NIH considers the sharing of unique analysis resources developed by way of NIH-sponsored analysis an important means to enhance the value and further the advancement with the analysis. When resources have been developed with NIH funds and the associated analysis findings published or provided to NIH, it is critical that they be made readily available for study purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained inside the Resource Sharing section of the application (see

(a) Data Sharing Plan: Regardless from the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared,Buy Windows 7 Professional, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH system contact (see Data-Sharing Policy or

(b) Sharing Model Organisms: Regardless from the amount requested, all programs where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and connected 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 with the amount requested, applicants seeking funding for the genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an proper explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further info see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and

Foreign Purposes (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 health sciences inside the United States.

Section V. Application Critique Information

1. Criteria

Only the assessment criteria described under will be regarded as from the assessment process.

2. Critique and Variety Process
Review Process

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an proper peer assessment group convened from the National Cancer Institute and in accordance with NIH peer evaluation procedures ( employing the assessment criteria stated below.

As aspect of the scientific peer evaluation, all applications will:
Undergo a selection process in which only those programs deemed to have the highest scientific and technical merit, generally the top half of purposes under evaluation, will be discussed and assigned a rating; Receive a written critique; and Receive a second level of evaluation through the Nationwide Cancer Advisory Board
Because the Investigation Strategy component is limited to 12 pages, an exploratory/developmental grant software need not have extensive background material or preliminary data 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 programs. Proper justification for that 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 applications and should focus on demonstration of technical feasibility.

The mission with the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As portion of this mission, purposes submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral investigation are evaluated for scientific and technical merit via the NIH peer review system.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment from the likelihood for the project to exert a sustained, powerful influence on the investigation field(s) involved, in consideration from the following five core critique criteria, and additional review criteria (as applicable for that project proposed).

Core Critique Criteria. Reviewers will consider each with the five evaluation criteria under from the determination of scientific and technical merit, and give a separate score for each. An software does not need to get strong in all categories to get judged likely to have major scientific impact. For example, a project that by its nature is not revolutionary may be essential to advance a field.

Significance. Does the project address an essential problem or a critical barrier to progress inside the field? If the aims with the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion from the aims change the concepts, methods, technologies, treatments, companies, 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 superior 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 the project?

Innovation. Does the application challenge and seek to shift current study or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of analysis or novel in a broad sense? Is actually 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 from the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is within the early stages of improvement, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical investigation, are the plans for 1) protection of human subjects from investigation risks, and 2) inclusion of minorities and members of both ######es/genders, as well as the inclusion of children, justified in terms of your 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 that project proposed? Will the project benefit from unique features of your scientific environment, subject populations, or collaborative arrangements?

Additional Critique Criteria

As applicable for the project proposed, reviewers will consider the subsequent additional items from the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For study that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from analysis risk relating to their participation according to the following five evaluation criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge for being gained,office 2007 standard key, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more from the six categories of research that are exempt under 45 CFR Aspect 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 research, 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 the scientific assessment according to the subsequent five points: 1) proposed use of the animals, and species, strains, ages, ######, and numbers to get used; 2) justifications for the use of animals and for your 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 from 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 Programs. When reviewing a Resubmission application (formerly called an amended software), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Revision Apps. When reviewing a Revision application (formerly called a competing supplement application),Cheap Office Professional Plus 2010, the committee will consider the appropriateness from the proposed expansion of the scope with the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval from the committee, then the committee will consider whether the responses to comments from the previous scientific evaluation 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 Assessment Considerations

As applicable for your project proposed, reviewers will address each from the following 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 price range and the requested period of support are fully justified and reasonable in relation to the proposed investigation.

Select Agents Investigation. Reviewers will assess the details provided in this section of the software, including 1) the Select Agent(s) to get used in the proposed study, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for proper biosafety, biocontainment, and security with the 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,Buy Windows 7 Home Basic, 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 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 purposes submitted in response to this FOA. The following will be regarded as in making funding decisions:
Scientific merit of your proposed project as determined by peer evaluation. Availability of funds. Relevance of 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 evaluation of your application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

If the software is under consideration for funding, NIH will request "just-in-time" info from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Component II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
A formal notification in the type 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 just before receipt of your NoA are at the recipient's risk. These costs may be reimbursed only to the extent deemed allowable pre-award costs. See Section IV.5., Funding Restrictions.
2. Administrative and Countrywide Policy Demands
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as portion of your NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and 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 inside 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 opportunity and welcome the possibility to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (plan), peer assessment, and financial or grants management issues:

1. Scientific/Research Contact(s):

Richard Aragon, Ph.D.
Office with the Director
Nationwide Cancer Institute (NCI)
11400 Rockville Pike, Suite 700
Rockville, MD 20852-2580
Telephone: (301) 435-8437
Fax: (301) 480-4814
Email: raragon@mail.nih.gov

J. Randy Knowlton PhD
Division of Cancer Biology (DCB)
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)
Countrywide Cancer Institute (NCI)
6130 Executive Boulevard, Room 5100
Bethesda, MD 20892-7324
Rockville, MD 20852
Telephone: (301) 594-7344
Fax: (301) 402-4279
Email: vermam@mail.nih.gov

Lynn Sorbara, Ph.D.
Division of Cancer Prevention (DCP)
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 Critique 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 Investigation:
Recipients of PHS support for activities involving live, vertebrate animals should comply with PHS Policy on Humane Care and Use of Laboratory Animals ( as mandated by the Wellbeing Investigation Extension Act of 1985 ( and the USDA Animal Welfare Regulations ( as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects should 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 the knowledge gained or to become gained (

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,

Sharing Study Data:
Investigators submitting an NIH software seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible ( Investigators should seek guidance from their institutions, on issues associated to institutional policies and local institutional critique board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease via 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 applications, 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 acceptable explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional info, see

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of crucial analysis resources including the sharing of model organisms for biomedical analysis (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 employing 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 be included in all apps where the improvement of model organisms is anticipated.
Access to Analysis Data through the Freedom of Details Act:
The Office of Management and Finances (OMB) Circular A-110 has been revised to provide access to study data by way of the Freedom of Info Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part 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 through FOIA. It is essential for applicants to understand the basic scope of this amendment. NIH has provided advice at Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for that data and manage the distribution for an indefinite period of time. If so, the software should include a description of your archiving plan within the study design and include info about this in the finances justification section with 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 Study:
It is the policy of your NIH that women and members of minority groups and their sub-populations should be included in all NIH-supported clinical investigation projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the well being with the subjects or the objective from the investigation. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical investigation should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Study ( a complete 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 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 proper, to address differences by ######/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators ought 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 Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical investigation, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing analysis involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in 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 apps 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 from the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( It is the responsibility of the applicant to provide in the project description and elsewhere in the software as suitable, the official NIH identifier(s) for your hESC line(s) to be used from the proposed study.

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 edition of their final, peer-reviewed manuscripts upon acceptance for publication, for being made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at ( For more details, see the Public Access webpage at

Standards for Privacy of Individually Identifiable Wellness Data:
The Division of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Well being Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule can be a federal regulation under the Wellness Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health details, and is administered and enforced through the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides details on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Details on the impact from the HIPAA Privacy Rule on NIH processes involving the evaluation, funding, and progress monitoring of grants, cooperative agreements, and analysis contracts can be found at

URLs in NIH Grant Purposes or Appendices:
All purposes and proposals for NIH funding must be self-contained within specified page limitations. For publications listed inside the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must 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 of your NIH grant application. A URL or PMC submission identification quantity citation may be repeated in each of these sections as appropriate. There is no limit to the amount of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Wellbeing Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led nationwide 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 program is described from the Catalog of Federal Domestic Support at and is not subject to the intergovernmental critique requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of your Public Well being 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 in 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, wellbeing care, or early childhood improvement providers are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental wellness of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified wellbeing 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 critical component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a investigation career unfettered from the burden of student loan debt. Be aware 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 analysis. For further info, please see:

treasure! Unlikely wow gold This is not so treasured wow powerleveling things of this group should wow accounts seem. Should all be ancient buy wow gold monk, brought to the berth extremity cheap wow gold son. St. unanticipated association .