EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK), (http://www2.niddk.nih.gov)
Title: Pilot and Feasibility Clinical Research Grants in Kidney or
Urologic Diseases (R21)
Announcement
Type
This Funding
Opportunity Announcement (FOA) is a reissue of PAR-06-113.
Program
Announcement (PA) Number: PAR-09-077
NOTICE: Applications
submitted in response to this Funding Opportunity Announcement (FOA) for
Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424
Research and Related (R&R) forms and the SF424 (R&R) Application
Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application 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)
93.847
Key Dates
Release/Posted
Date: January 14, 2009
Opening Date: January 16, 2009
(Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): N/A
NOTE: On-time submission requires that
applications be successfully submitted to Grants.gov no later than 5:00 p.m.
local time (of the applicant institution/organization).
Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS
Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not
Applicable
Expiration Date: January 8, 2012
Due
Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Application and Submission
Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4.
Intergovernmental Review
5. Funding Restrictions
6.
Other Submission Requirements and Information
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
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 Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The Division of Kidney, Urologic, and Hematologic Diseases of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has a longstanding and substantial interest in clinical research concerning the prevention and treatment of kidney diseases and urologic disorders. This funding opportunity announcement (FOA) is a re-issuance of PAR-06-113 and specifically encourages the submission of applications for small scale or pilot and feasibility clinical and translational research studies, including epidemiological studies or clinical trials related to kidney or urologic disease research that address important clinical and translational questions and are potentially of high impact. It is anticipated that some applications for pilot and feasibility studies may lead to full-scale clinical studies including evaluation of diagnostic strategies, epidemiologic studies, or trials in the diagnosis, prevention, or treatment of kidney or urologic diseases.
These grants may be used to plan, evaluate the feasibility, or implement clinical trials that assess pharmacological, dietary, surgical, or behavioral interventions for the prevention or treatment of kidney or urologic disease. Small scale or pilot epidemiological studies are also encouraged. It is anticipated that some of these grants will serve as a basis of planning future multi-center research project grant applications (R01), for cooperative agreement (U01) applications or for multi-center clinical study cooperative agreement (U34/U01; PAR-08-058) applications. The purpose of the planning grant is to provide support for investigators at different institutions for meeting and designing common protocols, entry criteria, data management systems and analysis plans, and for generating pilot data for a clinical trial. This would allow investigators to obtain additional expertise during the trial planning phase in areas such as clinical trial design and statistics to ultimately develop an R01 grant to support the clinical trial. A pilot clinical grant to plan a large clinical trial (defined as a trial projected to exceed $500,000 direct costs per year) will only be accepted after prior discussions and approval from NIDDK Staff. Both new and experienced investigators in relevant fields and disciplines are encouraged to apply for these grants.
It is anticipated that applications submitted in response to this FOA will focus on clinical studies. Basic laboratory research, studies of laboratory animals, or clinical hematology studies are not appropriate for this FOA. Studies that do not involve human subjects or are not human studies will not be supported by this funding opportunity.
Background
Recent estimates of chronic kidney disease (CKD) in the US population, obtained through analysis of the Third National Health and Nutrition Examination Survey (NHANES III), indicate that it is a common medical problem, affecting over 26 million people in the US, and that its prevalence in the US has increased significantly over the last decade. Most cases of CKD observed in the US occur in the setting of diabetes, hypertension, glomerular disease and polycystic kidney disease.
With the increase in CKD, the incidence of end-stage renal disease (ESRD) has also been steadily increasing in the adult US population. The US Renal Data System (USRDS) 2008 Annual Data Report indicates that from 1990 2006 the incidence rate of ESRD has increased from 220 to 360 per million population. Although incidence rates remained stable between 2000-2005, the rate in 2006 increased significantly by 2.1%. The substantial morbidity and mortality experienced by ESRD patients and persons with earlier stages of CKD remains unabated. The increasing rate of ESRD has also markedly increased waiting time for cadaveric transplantation such that the rate of kidney transplants per patient year on dialysis has steadily declined by 47%, from 5.7 per 100 dialysis patients in 1990 to 3.0% in 2006.
Acute kidney injury (AKI; sometimes referred to as Acute Renal Failure) in hospitalized patients is also a significant and increasing problem in the US. Medical management of acute kidney injury has traditionally consisted of supportive care, with renal replacement therapy implemented for the most severe cases. Despite such interventions in AKI, however, mortality rates in affected patients remain very high (>50% in some series).
In view of these observations suggesting a high prevalence of CKD, and increasing ESRD and AKI in the US population, NIDDK has sponsored a number of large, multi-center studies of specific kidney disorders. These studies include prospective investigations in chronic kidney disease, dialysis access, polycystic kidney disease, focal and segmental glomerulosclerosis, and acute kidney injury. In planning and performing these studies, however, it has been apparent that the process for identifying appropriate interventions for both single and multi-center trials in kidney disease must be improved. This is particularly evident in the current small number of clinical studies related to kidney disease that could ultimately be expanded to large-scale clinical trials.
Urological diseases and disorders inflict a significant impact on the health care burden of the United States. The NIDDK funded Urologic Diseases in America Project (UDA) has published data on 16 of the most important urological diseases. Some urologic conditions are common in the US population, such as urinary tract infection, which afflicts 13 percent of adult females and 2 percent of adult males each year at a cost to the US health care system of over $3 billion. Urinary incontinence is very common in the elderly (60 and over) with 38 percent of females and 17 percent of males reporting some level of incontinence. Although the direct medical costs of incontinence are not great, the morbidity associated with incontinence and the indirect costs to persons with this condition are significant. Similarly, benign prostatic hypertrophy (BPH) associated with lower urinary tract symptoms (LUTS) is very common in older adult males, with almost one-quarter of men over age 50 reporting symptoms of some kind. As with incontinence, BPH does not result in large direct medical care costs but does result in considerable morbidity and substantially reduced quality of life. Urolithiasis, or kidney stones, is both common and a source of considerable pain and health care costs. Five percent of Americans will have a symptomatic stone at some time in their life and the annual health care costs are over $2 billion.
Information on the burden of other non-malignant urological diseases and disorders such as erectile dysfunction, the chronic pelvic pain syndromes such as chronic prostatitis and interstitial cystitis, and the many congenital and acquired pediatric urological disorders is not as complete but available studies suggest that these conditions are common and increasing, burdensome and costly.
The morbidity of many of these non-malignant urological disorders is often exacerbated by other common co-morbid conditions such as diabetes and obesity. Advancement in accurate diagnosis, prevention and treatment of these diseases is hampered by many factors including a lack of well-validated methods to access disease progression, by a lack of insight into the genetics of the disorders, absence of well formulated and tested definitions of the disease and its possible clinical subcategories, by a lack of rigorous epidemiological data and by an incomplete understanding of the pathophysiology of many of these diseases and disorders. In addition, in many cases the armamentarium of available diagnostic approaches has not been applied to these diseases.
The goal of this FOA is to provide flexibility for initiating preliminary, short-term studies, thus allowing new ideas to be investigated in a more expeditious manner without stringent requirements for preliminary data. Such support is needed to encourage new and experienced investigators to pursue new approaches, underdeveloped topics, or high risk research. If successful, these awards should lead to significant scientific advances in the treatment of kidney and urologic diseases.
As the kidney and urological diseases occur in a variety of clinical settings, and are associated with a number of co-morbid conditions, it is anticipated that applications submitted in response to this FOA could address a number of different aspects concerning the prevention, diagnosis, or treatment of patients with kidney and urological diseases.
Relevant topics of study evaluating kidney disease in adults or children could include (but are not limited to):
Relevant topics for study of the non-malignant urological diseases in adults or children could include (but are not limited to):
The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view.These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data.By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.
The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area.These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, or applications that could have a major impact on a field of clinical research.
Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism.For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel.These studies should break new ground or extend previous discoveries toward new directions or applications.
See Section VIII, Other Information
- Required Federal Citations, for policies related
to this announcement.
Section
II. Award Information
1. Mechanism of Support
This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts see SF424 (R&R) Application Guide). It also uses the modular budget format (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 3.4, Modular Budget Component, of the Application Guide).
All foreign applicants must complete and submit budget requests using the Research & Related Budget component.
2. Funds Available
Because the nature and scope of the proposed
research will vary from application to application, it is anticipated that the
size and duration of each award will also vary. Although the financial plans of
the Institutes and Centers (ICs) provide support for this program, awards pursuant
to this funding opportunity are contingent upon the availability of funds and
the submission of a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
F&A costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004, November 2,
2004.
Section
III. Eligibility Information
1.
Eligible Applicants
1.A.
Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an 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 information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The
decision of whether to apply for a grant with a single PD/PI or multiple
PDs/PIs grant is the responsibility of the investigators and applicant
organizations and should be determined by the scientific goals of the project.
Applications for grants with multiple PDs/PIs will require additional
information, as outlined in the instructions below. 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 of
the individual PDs/PIs will be factored into the assessment of the overall
scientific merit of 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 appropriate, to a collaborating
organization, for the proper conduct of the project or program, including the
submission of required reports. For further information on multiple PDs/PIs,
please see http://grants.nih.gov/grants/multi_pi.
2. Cost
Sharing or Matching
This program
does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date (and any other due dates for FY2010 funding and beyond), all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted for due dates prior to January 25, 2009 will be permitted two resubmissions (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 applications after that date.
Renewals. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) applications will not be accepted.
Basic laboratory research, studies of laboratory animals, or clinical hematology studies are not appropriate for this FOA. Studies that do not involve human subjects or are not human studies will not be supported through this Funding Opportunity Announcement.
Section IV. Application and Submission Information
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of 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 must be complete by the submission deadline for the application to be considered ?on-time? (see 3.C.1 for more information about on-time submission).
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 http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure 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.
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Several of the steps of 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 in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must
download the SF424 (R&R) application forms and SF424 (R&R) Application
Guide for this FOA through Grants.gov/Apply.
Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further assistance, contact GrantsInfo --
Telephone 301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424 (R&R) (Cover
component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate
(See Section
IV.6., Special Instructions,
regarding appropriate required budget component.)
Optional Components:
PHS398 Cover Letter
File
Research & Related Subaward Budget Attachment(s)
Form
Foreign
Organizations (Non-domestic [non-U.S.] Entities)
NIH policies concerning
grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from Foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through 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 INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be 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 the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component.All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission.The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research 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 of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts.The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In 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, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only.Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 3.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular 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 16, 2009 (Earliest date
an application may be submitted to Grants.gov)
Application Due Date(s): Standard dates apply, please
see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Submitting an Application Electronically to the NIH
To submit an
application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow
Steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application
Processing
Applications may be submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5:00 p.m. local
time(of the applicant
institution/organization) on the application due date(s). (See Section
IV.3.A. for
all dates.) If
an application is not submitted by the due date(s) and time, the application
may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time:
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information 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 must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application 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 must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.