Accelerating Research Translation (ART) in Musculoskeletal and Skin Tissue Engineering and Regenerative Medicine

Accelerating Research Translation (ART) in Musculoskeletal and Skin Tissue Engineering and Regenerative Medicine is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is seeking applications to accelerate research translation in musculoskeletal and skin tissue engineering and regenerative medicine (TE/RM).

Expired RFA-AR-11-004: NIAMS Accelerating Research Translation (ART) in Musculoskeletal and Skin Tissue Engineering and Regenerative Medicine Competitive Revision Award (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services National Institutes of Health (NIH), ( http://www.

nih. gov ) Participating Organizations Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ( http://www. niams.

nih. gov/ ) Title: NIAMS A ccelerating R esearch T ranslation (ART) in Musculoskeletal and Skin Tissue Engineering and Regenerative Medicine Competitive Revision Award (R01) Update: The following update relating to this announcement has been issued: August 16, 2010 - 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 . for Applications (RFA) Number: 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 BE SUBMITTED IN PAPER FORMAT.

in conjunction with the application guidelines included with this announcement for Grants (hereafter called Grants. gov/Apply). 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 . Domestic Assistance Number(s) Release/Posted Date: February 26, 2010 2010 (Earliest date an application may be submitted to Grants. gov) Letters of Intent Receipt 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): August 4 , 2010 Date(s): November , 201 0 Council Review Date(s): January , 2011 Earliest Anticipated Start Date(s): April 1, 2011 Information To Be Available Date (Activation Date): Not Applicable Purpose .

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) solicits A ccelerating R esearch T ranslation (AR T) applications in musculoskeletal and skin tissue engineering and regenerative medicine (TE/RM).

The ART awards intend to offer revision support (formerly referred to as a competing supplement ) to active NIAMS R01 , P01 and P50 (parent) grants for conduct ing large animal pre-clinical studies with the potential to immediately lead to human trials in musculoskeletal and These studies will 1) provide data required for Phase I/II human clinical trials in musculoskeletal and skin TE/RM, 2) demonstrate efficacy of a TE/RM therapy in musculoskeletal and skin TE/RM, or 3) develop pre-clinical large animal models that will have the potential to immediately lead TE/RM research into Phase I/II clinical trials .

Early stage translational studies using small animals such as rodent and rabbit are not responsive to this FOA. Mechanism of Support. This FOA will utilize the NIH revision to R01 grant parallel with a FOA ( RFA-AR-11-005 ) of identical scientific scope that solicits applications under the NIAMS P01 Funds Available and Anticipated Number of Awards.

The NIAMS plans to commit $1M in total cost in FY 2011 to make 1 to 3 ART awards for both RFA-AR-11-004 and RFA-AR-11-005. Awards issued under this FOA are contingent upon the availability of funds and the submission of meritorious applications. Budget and Project Period.

It is expected that all or the majority of the proposed research in an ART revision application will be carried out within the first year of the project period; however, if necessary, up to one additional year may be requested. The total project period for each ART revision application may not exceed two years.

Direct costs are limited to $650,000 over the entire project requesting a two-year project period, a maximum amount up to 10% of the requested direct costs for the entire project period may be requested for the second budget period. In addition, the requested end date of the ART project may not exceed the end date of the parent project . Equipment requested in rare circumstances with exceptional justification .

Consultation with your NIAMS Program Directors is highly month prior to application submission date for any equipment request . Strategy Length: The ART revision (R01 ) application Research Strategy section of the PHS398 may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. Institutions/Organizations.

Institutions/organizations listed in Section III, 1. A. are eligible Eligible Project Directors/Principal Investigators (PDs/PIs).

I ndividuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/ organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Number of PDs/PIs.

More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application. The contact PD/PI must be the same as that of the parent grant. A new investigator added to the parent grant as a PI with this revision will lose his or her new PI status if the ART of Applications.

Applicants may submit more than one application, provided each application is scientifically distinct. However, only one ART application can be submitted for each active parent Resubmissions. Resubmission applications are not permitted in applications are not permitted in response to this FOA.

Special Date(s). his FOA uses non-standard Review and Anticipated Start Dates . Materials.

See Section IV. 1 for General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites: (R&R) Application and Electronic Submission Information: http://grants.

nih. gov/grants/funding/424/index. htm information on Electronic Submission of Grant Applications: http://era.

nih. gov/ElectronicReceipt/ Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936 Part I Overview Information Part II Full Text of Announcement Section I.

Funding Opportunity Section II. Award Information Section III. Eligibility Information 2.

Cost Sharing or Matching 3. Other-Special Eligibility Criteria Section IV. Application and 1.

Request Application Information 2. Content and Form of Application Submission 3. Submission Dates and Times A.

Receipt, Review, and Anticipated B. Submitting an Application Electronically to the NIH C. Application Processing 4.

Intergovernmental Review 6. Other Submission Requirements Section V. Application Review Information 2.

Review and Selection Process A. Additional Review Criteria B. Additional Review Considerations Anticipated Announcement and Award Dates Section VI.

Award Administration 2. Administrative and National Policy Requirements 1. Scientific/Research Contact(s) Financial/Grants Management Contact(s) VIII.

Other Information - Required Federal Citations - Full Text of Announcement Section I. Funding Opportunity Description Regenerative medicine encompasses the knowledge and practice of tissue engineering , as well as healing through endogenous recruitment/secretion or exogenous delivery of appropriate cells, biomolecul es, and supporting structures.

It can also involve the use of gene therapy to replace a missing or defective protein or enhance tissue Injury, loss, and degeneration of musculoskeletal and skin tissues, often within a complex multi-tissue environment, constitute a very significant public health problem and are often responsible for much human suffering and substantial health care costs.

R epair and restoration of these tissues present engineering and regenerative medicine (TE/RM) offer tremendous these challenges , and for prolonging or enhancing the quality of life. The NIH has made significant invest ment in r egenerative medicine research ( http://report. nih.

gov/rcdc/categories/ ). established that animal studies play a critical role in translational research. Validation of research findings in large animals holds the key to successful TE/RM translation to clinics .

Testing in large animals is often required by the U.S. Food and Drug Administration (FDA) for the approval of TE/RM products prior to human use in clinical trials . For example, t he 2007 FDA draft guideline for cartilage repair ( http://www. fda.

gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm073390. htm ) states goats, sheep, and horses are the most frequently used large animal models for cartilage repair .

need to support preclinical studies using large animal s and develop standardized large animal models for accelerating research translation in TE/RM is reinforced in some of the recent NIH sponsored meetings, such as a workshop on Translational Models for Musculoskeletal Tissue Engineering and Regenerative Medicine ( s elected review papers from this workshop are published in th e journal of Tissue Engineering Part B , Volume: 16, Number: 1 February 2010 ) , and two NIAMS working group meetings at the Orthopaedic Research Society and the Wound Healing Society annual meetings ( summary at http://www.

niams. nih. gov/News_and_Events/Meetings_and_Events/Reports/2008/SBIR_STTR_tiseng_regenmed.

asp ). Funding pre-clinical studies using large animal s is an integral part in accelerating musculoskeletal and skin TE/RM .

To achieve this goal, the NIAMS issues this FOA to solicit the ART revision applications to active NIAMS R01, P01 and P50 (parent) grants for conducting large animal pre-clinical studies with the potential to immediately lead to human trials in musculoskeletal and skin provide data required for Phase I/II human clinical trials in musculoskeletal and skin TE/RM, 2) demonstrate efficacy of a TE/RM therapy in musculoskeletal and skin TE/RM, or 3) develop pre-clinical large animal models that will have the potential to immediately lead TE/RM research into Phase I/II clinical trials .

Early stage translational studies using small animals such as rodent and rabbit are not responsive to this FOA. Types of large animal pre-clinical studies responsive to this FOA include, but are not limited to: safety and/or eff icacy of cell or gene therapies using TE/RM strategies with potential to immediately lead to Phase I/II human clinical trials for arthritis or musculoskeletal or skin diseases or disorders.

of scaffolds, small molecule drugs, biologics or molecular therapeutics (e.g., antisense oligonucleotides) with po tential to immediately lead to P hase I /II human clinical trials to promote the regeneration of bone, cartilage, intervertebral disc, ligament, meniscus, muscle, tendon, or skin Applicants are invited to visit the NIAMS ART website for answers to commonly asked questions ( http ://www. niams. nih.

gov/ Funding/Fu nding_Oppo rtunities/Supported_Scientific_Ar eas/Musculoskeletal_Diseases/art_faq. asp ). See Section VIII, Other Information - Required Federal Citations , for policies related to this FOA will use the NIH R01 revision (formerly referred to as competitive supplement ) 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) must 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.

The NIAMS plans to commit $1M in total cost in FY 2011 to fund 1 to 3 ART awards for both RFA-AR-11-004 and RFA-AR-11-005. Direct costs requested for the ART award are limited to $650,000 over the entire project 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 and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004 . grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in Section III.

Eligibility Information organizations/institutions are eligible to apply: Controlled Institutions of Higher Education Institutions of Higher Education Historically Black Colleges Tribally Controlled Colleges Alaska Native and Native Hawaiian Serving Nonprofits with 501(c)(3) IRS Status (Other than Institutions of without 501(c)(3) IRS Status (Other than Institutions of Higher Education) Organizations (Other than Small Businesses) American Tribal Governments (Federally Recognized) American Tribally Designated Organizations Housing Authorities/Indian Housing Authorities U.S. Territory or Possession American Tribal Governments (Other than Federally Recognized) (non-U.S.) Entities (Foreign Organizations) Eligible Agencies of the Federal Faith-based or Community-based Organizations This FOA is a revision that involves an active NIAMS grant .

Only current active NIAMS R01 grantees are eligible to submit applications to this F O A. NIAMS P01 and P50 grantees are eligible to submit applications under RFA-AR-11-005 . 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 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 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 . This program does not require cost sharing as defined in the current NIH The ART awards will be made to active NIAMS R01, P01 and P50 grant ee s only. The funding period requested in the revision application must not exceed that of a parent of Applications.

Applicants may submit more than one application, provided each application is scientifically distinct. However, only one ART application can be submitted for each active parent grant. Revision applications that are the same as or similar to previous ART awards are not allowed.

Resubmissions. Resubmission applications are not permitted in response to applications are not permitted in response to this FOA . Section IV.

Application and Submission Information 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.

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 is required for institutions/organizations at both: Grants. gov ( http://www.

grants. gov/applicants/get_registered. jsp ) eRA Commons ( http://era.

nih. gov/ElectronicReceipt/preparing. htm ) PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

additional separate actions are required before an applicant can submit an electronic application, as follows: Organizational/Institutional Registration in Grants. gov/Get Registered Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants. gov registration process.

If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration. The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.

Direct questions regarding Grants. gov registration to: Business Hours: M-F 7:00 a. m.

- 9:00 p. m. Eastern Time 2) Organizational/Institutional Registration in the eRA Commons To find out if an organization is already Commons-registered, see Organizations Registered in NIH eRA Commons.

Direct questions regarding the Commons registration to: Phone: 301-402-7469 or 866-504-9552 (Toll Free) Business hours M-F 7:00 a. m. 8:00 p.

m. Eastern Time Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.

hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an NIH Internet Assisted Review (IAR) role, both roles should exist under one Commons account.

When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons. This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image. Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.

gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants. gov registration, eRA Commons registration and the SF424 (R&R) Request Application Information 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 assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: [email protected] .

for the hearing impaired: TTY: (301) 451-5936 Content and Form of Application Submission applications using the SF424 (R&R) application forms for this FOA through Grants. gov/Apply and in accordance with the SF424 (R&R) Application Guide ( http://grants. nih.

gov/grants/funding/424/index. htm ). 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/PI’s 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 Submission of Grant Applications . 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 Project/Performance Site Locations Research & Related Other Project Information Research & Related Senior/Key Person PHS398 Cover Page Supplement PHS398 Modular Budget or Research & Related appropriate (See Section IV.

6 . , Special Instructions , regarding appropriate required budget component.) Research & Related Subaward Budget Attachment(s) Organizations ( Non-Domestic 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.

from Foreign organizations must: Request budgets in U.S. dollars; detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms not the PHS398 Modular Budget component)( see NOT-OD-06-096 ); Not include any charge-back of customs and import Comply with the format specifications, which are based upon a standard U.S. paper size of 8.

5 x 11 within each PDF; If appropriate, request funds for up to 8% administrative costs (excluding equipment) ( see NOT-OD-01-028 , March 29, Comply with Federal/NIH policies on human subjects, animals, and biohazards; and Comply with Federal/NIH biosafety and biosecurity regulations (see Section VI. 2 . , Administrative and National Policy Requirements ).

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.

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. for the Contact PD/PI should be entered in item 15 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.

proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the 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.

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).

within a single institution, follow the instructions contained in the SF424 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 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 5.

4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component. Submission Dates and Times See Section IV. 3.

A. for details. 3.

A. Submission, Review, and Anticipated Start Dates application may be submitted to Grants. gov) Letters of Intent Receipt Date(s): July Application Due Date(s): August Review Date(s): November, 2010 Council Review Date(s): January, Earliest Anticipated Start Date(s): April applicants are asked to submit a letter of intent that includes the following Descriptive title of proposed research.

Name, address, and telephone number of the Names of other key personnel. Participating institutions. Number and title of this funding opportunity.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed The letter of intent should be sent to: Division of Musculoskeletal Diseases Democracy Blvd, Suite 800 3. B.

Submitting an Application Electronically to the 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.

All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a . pdf extension must be used. review, applicants are requested to notify the NIAMS Referral Office by email ( [email protected] ) when the application has been submitted.

Please include the FOA number and title, PD/PI name, and title of the application. 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 : registrations must be complete prior to the submission deadline application must receive a Grants. gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.

m. local time on the submission deadline date. system identified errors/warnings must be corrected and the submission process completed within the error correction window.

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! 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 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.

Please note that the following application submission must be on-time. 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 number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

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 acceptable, no further action is necessary.

The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays. 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 part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected.

Once rejected, applicants should follow the instructions for correcting errors in Section application guide, 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 to be addressed now. Remember, warnings do not stop further application processing.

If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process. the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.

gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t 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. 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 application still can be submitted, but it will be subject to late policy guidelines and may not be accepted.

The reason for this delay should be explained in the cover letter attachment. the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive applications will not be reviewed.

will be an acknowledgement of receipt of applications from Grants. gov and the Commons . The submitting AOR/SO receives the Grants.

gov acknowledgments.