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 Mental Health (NIMH), (http://www.nimh.nih.gov)
Title: Pilot Intervention and
Services Research Grants (R34)
Announcement Type
This is a reissue of PAR-06-248.
Program Announcement (PA) Number: PAR-09-173
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)
93.242
Key Dates
Release/Posted
Date: April 22, 2009
Opening Date: May 18, 2009 (Earliest
date an application may be submitted to Grants.gov)
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: (Extended to September 8, 2012 per NOT-MH-12-024), Original Date May 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
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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
purpose of this Funding Opportunity Announcement
(FOA) is to encourage research on 1) the development and/or pilot testing of
new or adapted interventions, 2) the
adaptation and/or pilot testing of interventions with demonstrated efficacy for
use in broader scale effectiveness trials, or 3)
innovative services research directions that require preliminary testing or
development, as detailed in the sub-headed sections that follow. The R34 award
mechanism provides resources for evaluating the feasibility, tolerability,
acceptability, and safety of novel approaches to
improving mental health and modifying health risk behavior, and for obtaining
the preliminary data needed as a pre-requisite to a larger-scale intervention
(efficacy or effectiveness) or services study.
For the purpose of intervention pilot research, "intervention" is broadly defined to include psychosocial, pharmacologic, somatic or combination approaches to prevent the onset of disorder; efforts to treat disorder in the acute and later phases, such as continuation and maintenance; efforts to prevent relapse, side effects, or co-morbid symptoms and disorders; and rehabilitative efforts to reduce residual symptoms and/or enhance functioning. This mechanism is also intended to support innovative pilot services research to identify mutable factors that impact access, utilization, quality, and outcomes of mental health services and to inform or pilot test patient-, provider-, organizational-, or policy- level services interventions to improve care quality, coordination, or delivery.
Pilot intervention studies submitted in response to this FOA do not necessarily need to be scaled down Randomized Controlled Trials (RCTs) that propose formal tests of intervention outcomes. Indeed, as described below, depending on the stage of intervention development, the R34 project might not involve randomization, but rather might focus on earlier stages such as the operationalization of an intervention protocol and corresponding manual and/or pilot testing of the experimental intervention in a case series with a sample drawn from the target population. Most importantly, the R34 should propose the developmental work to be performed that would enhance the probability of success in a larger trial. This is best done by working out the details of the experimental protocols, including the assessment protocol, the experimental intervention protocol, as well as the comparison intervention protocol and randomization procedures (if appropriate); examining the feasibility of recruiting and retaining participants into the study conditions (including the experimental condition and the comparison condition, if relevant); and developing supportive materials and resources.
Accordingly, collection of preliminary data regarding feasibility, acceptability, safety, tolerability, and target outcomes is appropriate. However, given the intended pilot nature of the R34 mechanism, conducting formal tests of outcomes or attempting to obtain an estimate of an effect size is often not justified. Given the limited sample sizes typically supportable under this pilot study mechanism, the variability in the effect sizes obtained is often so large as to be unreliable. Thus, using these potentially unstable effect size estimates in power calculations for larger studies, without regard to clinical meaningfulness, is not advisable.
Likewise, pilot services studies that propose non-RCT designs do not need to be a reduced scope version of the anticipated larger study, but should instead attempt to develop and refine the research strategies to be utilized in the subsequent definitive study.
NIMH intervention and services research is aimed at preventing or ameliorating mental disorders, emotional or behavioral problems, the co-occurrence of mental, physical and substance abuse problems, HIV infections, and the functional consequences of these problems across the life span. This FOA addresses recommendations noted in several reports of the National Advisory Mental Health Council, including Treatment Research in Mental Illness: Improving the Nations Public Mental Health Care through NIMH Funded Interventions Research (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/interventions-research.pdf) and The Road Ahead: Partnerships to Transform Services (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/road-ahead.pdf). Studies that address research objectives outlined in the NIMH Strategic Plan are encouraged (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml).
1. Development and Pilot Testing of New or Adapted Interventions
Intervention development can be considered to have three stages: 1) conceptualizing an intervention based on theory and empirical research, 2) developing and standardizing the intervention, and 3) pilot testing.
Stage 1. When proposing a new or adapted intervention, the application should explicate a clear conceptual link between relevant psychological or behavioral factors, various intervention components being proposed (including a description of the purported mechanisms of action by which these components are hypothesized to have an effect), and their relationship to the particular aspects of outcome that are being targeted. The need for a new or adapted intervention should be justified in terms of the base-rate and public health significance of the target problem, the limitations of existing intervention approaches, and the expected increment in effect sizes in comparison to currently available intervention approaches. The justification for a new or adapted intervention might in part be based on data from prior research describing characteristics of client subgroups, settings, care providers or other relevant variables that are associated with non-response, partial response, or relapse. Accordingly, interventions might be designed or adapted to address conditions for which efficacious interventions are lacking or to target factors that have previously been identified with poor responses to existing approaches. High priority will be given to applications that demonstrate the systematic translation of basic behavioral and neurobiological processes (e.g., cognition, memory, attention, emotion, personality) into applied interventions. Attention should also be given to the effects of these interventions with underserved populations in disparate social, economic, cultural and environmental contexts.
Stage 2. Standardization of an intervention primarily involves development or adaptation of the intervention protocol (e.g., psychotherapy manual, medication dosing schedule), including iterative refinements based on feedback from patients, care providers, and other investigators. This stage might also involve refinements to assessment strategies (e.g., measures to determine inclusion/exclusion; measures to assess psychiatric and other outcomes, such as indices of functioning and cost; and measures to assess acceptability of the intervention protocol, fidelity of provider implementation, and client/patient adherence).
Stage 3. Pilot and feasibility studies involve testing and further refining the intervention manual and measures developed in earlier stages of intervention development/refinement. Typically, data are gathered to examine the feasibility of: identifying, enrolling, and retaining participants; implementing the experimental intervention (and comparison condition, if relevant); and implementing the assessment protocols, including measures for assessing inclusion/exclusion, fidelity of intervention delivery, and outcomes. Depending on the characteristics of the disorder or target population, the nature of the intervention, and the stage of research program, pilot testing may take various forms. Pilot testing might involve systematic study of an uncontrolled case series or use of a small randomized pilot trial to explore feasibility of both the experimental intervention and the control condition that will be used in the subsequent definitive trial. Under other circumstances, alternative designs might be appropriate (e.g., quasi-experimental designs). The application should provide a clear justification for the type of experimental design chosen. In summary, the goal of this phase of research is to propose the most rigorous means of collecting data (in light of ethical or other limitations) that will inform a larger, more definitive test of the intervention in the future.
Given that boundaries between these stages are not discrete, investigators may propose research activities or methods from one or more of the above-noted stages. However, investigators are not expected to necessarily complete all stages of development during the 3-year duration of the award. Rather, the goals of the study should be clearly outlined and related to specific aims. Importantly, applications should propose feasible goals that can be accomplished within the time and funding constraints of this award while considering the aim of accomplishing the prerequisites for conducting a larger (e.g., R01) study.
Examples of possible intervention development or adaptation studies include, but are not limited to:
2. Adaptation and Pilot Testing for Effectiveness
The principal aim of effectiveness (or public health-oriented) research is to determine whether interventions with demonstrated efficacy under tightly controlled conditions can have a measurable beneficial effect when implemented in less precisely controlled circumstances with more heterogeneous populations, providers and settings. Typically, these studies have broader inclusion (i.e., relatively few exclusion criteria) and outcomes often include variables such as functioning (school, work, interpersonal, etc.), quality of life, mortality, institutionalization, costs, and health care resource use, in addition to measures of psychiatric morbidity.
When conducting effectiveness research on an intervention with previously demonstrated efficacy, information regarding its initial degree of "fit" within an applied setting (e.g., specialty or primary care, school or work site) and the iterative process that is expected to occur when altering the intervention for successful implementation within this setting should be articulated. Accordingly, pilot effectiveness research can be considered to have stages of research that parallel the stages of novel intervention development noted above, including: (stage 1) an initial stage where characteristics of typical patients, provider, and the community/practice setting in which the intervention will be transported are systematically considered; (stage 2) a phase in which adaptations to improve the fit of the intervention are operationalized and incorporated in intervention manuals and materials; and (stage 3) a stage in which the intervention is pilot tested. As with studies proposing novel intervention development, effectiveness pilot studies using the R34 mechanism are not necessarily expected to include all of these stages, but rather, the particular stages of intervention adaptation and pilot testing should be clearly outlined and justified, and the application should include a well-articulated plan for collecting feasibility data that will inform a subsequent definite effectiveness study.
Examples of possible effectiveness research questions include, but are not limited to:
3. Innovative Services Research
This funding opportunity is also intended to encourage applications to facilitate innovative services research directions that require preliminary testing or development. Such pilot studies might include research focused on mutable factors that impact access, utilization, quality, and outcomes of mental health services and to inform or pilot test patient-, provider-, organizational-, or policy- level services interventions to improve care quality, coordination, or delivery.
Research in these areas may require novel or mixed methodologies and/or innovative statistical approaches. Studies designed to develop and/or pilot test novel service interventions or service delivery models might reflect one or more of the three stages of intervention development described in the "Development and Pilot Testing of New or Adapted Interventions" section of this Program Announcement.
Examples of research applications in this area include but are not limited to:
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 NIMH R34 award mechanism. The Project
Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.
U.S. applicants requesting more than $250,000 in annual direct costs and 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
IC(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds.
The total project period for an
application submitted in response to this funding opportunity may not exceed
three years. Direct costs are limited to $450,000 over the R34 project period,
with no more than $225,000 in direct costs allowed in any single year.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications 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:
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). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1).Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals. Applicants may not submit a renewal application.
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.
The PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
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 the 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: GrantsInfo@nih.gov.
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 for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field 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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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: May 18, 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/applicants/apply_for_grants.jsp 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.