Research to Advance Vaccine Safety (R01)

Research to Advance Vaccine Safety (R01) is sponsored by National Institutes of Health. Supports research to enhance understanding of vaccine safety, including physiological and immunological responses, genetic variations affecting immune responses, and identification of risk factors and biomarkers.

Expired PA-08-256: Research to Advance Vaccine Safety (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Health and Human Services National Institutes of Health (NIH), ( http://www.

nih. gov/ ) Centers for Disease Control and Prevention (CDC) ( http://www. cdc.

gov ) Participating Organizations Institute of Allergy and Infectious Diseases (NIAID), http://www. niaid. nih.

gov National Institute of Mental Health (NIMH), http://www. nimh. nih.

gov National Institute of Nursing Research (NINR) http://www. ninr. nih.

gov Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), http://www. nichd. nih.

gov National Institute of Environmental Health Sciences (NIEHS), http://www. niehs. nih.

gov National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP/CDC), ( http://www. cdc. gov/nccdphp/ ) Title: Research to Advance Vaccine Update: The following update relating to this announcement has been issued: November 28, 2011 - This PA has been reissued as PA-12-037.

July 28, 2011 - See Notice NOT-AI-11-050. Extension of Expiration Date. September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011.

Adobe B1 forms are required for due dates on or after May 8, 2011. 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 . This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative.

The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions.

If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions. July 31, 2009 - See Notice NOT-AI-09-050 The purpose of this Amendment is to provide additional clarification/language.

Program Announcement (PA) Number: PA-08-256 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. MAY NOT BE SUBMITTED IN PAPER FORMAT. be read in conjunction with the application guidelines included with this announcement in Grants.

gov/Apply for Grants (hereafter called 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.

856, 93. 242, 93. 361, 93.

865, 93. 113, 93. 061 Opening Date:September 5, 2008 (Earliest date an application may be 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 . Review Date(s): Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward Review Date(s): Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward Anticipated Start Date(s): Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule.

htm#reviewandaward Information To Be Available Date (URL Activation Date): Not Applicable Date: (Extended to January 8, 2012 per NOT-AI-11-050 ), Original Date: September 8, 2011 entitled Research to Advance Vaccine Safety, is issued by the National Institutes of Health and encourages Research Project Grant (R01) applications from institutions/organizations that propose to support research that will contribute to the overall understanding of vaccine safety.

This R01 research opportunity invites studies that address scientific areas potentially relevant to vaccine safety such as 1) physiological and immunological responses to vaccines and vaccine components, 2) how genetic variations affect immune/physiological responses that may impact vaccine safety, 3) identification of risk factors and biological markers that may be used to assess whether there is a relationship between certain diseases or disorders and licensed vaccines, or 4) the application of genomic/molecular technologies to improve knowledge of FOA will use the NIH Research Project Grant (R01) grant mechanism and runs in parallel with a FOA of identical scientific scope, PA-08-257 that encourages applications under the NIH Exploratory/Developmental (R21) grant mechanism Funds Available and Anticipated Number of Awards.

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. The total amount awarded and the number of awards will depend upon the, numbers, quality, duration, and costs of the applications received. Budget and Project Period.

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.

Application Research Strategy Length: The R01 application Research Plan component of the PHS398 (Item 3) may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts (see also http://grants. nih. gov/grants/funding/funding_program.

htm ). Institutions/Organizations. Institutions/organizations listed in Section III, 1.

A. are eligible to Eligible Project Directors/Principal Investigators (PDs/PIs). Include Individuals 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 Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application. Number of Applications.

Applicants may submit more than one application, provided that each application is Resubmissions. Applicants may submit a resubmission application, but such applications must include an Introduction addressing the previous peer review critique (Summary Statement). may submit a renewal application.

Application Materials. See Section IV. 1 for application General Information.

For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites: SF424 (R&R) Application and Electronic Submission Information: http://grants. nih. gov/grants/funding/424/index.

htm 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 II Full Text of Announcement I. Funding Opportunity Description III.

Eligibility Information IV. Application and Submission Information of Application Submission A. Submission, Review, and Anticipated Start Dates B.

Submitting an Application Electronically to the NIH Submission Requirements and Information V. Application Review Information A. Additional Review Criteria B.

Additional Review Considerations C. Resource Sharing Plan(s) Announcement and Award Dates VI. Award Administration Information and National Policy Requirements 1.

Scientific/Research Contact(s) Section VIII. Other Information - Required Federal Citations Part II - Full Text of Announcement Section I. Funding Opportunity Description purpose of this funding opportunity announcement (FOA) is to support research that will contribute to the overall understanding of vaccine safety.

This research opportunity invites studies that address scientific areas potentially relevant to vaccine safety such as 1) physiological and immunological responses to vaccines and vaccine components, 2) how genetic variations affect immune/physiological responses that may impact vaccine safety, 3) identification of risk factors and biological markers that may be used to assess whether there is a relationship between certain diseases or disorders and licensed vaccines, or 4) the application of genomic/molecular technologies to improve knowledge of vaccine Vaccines have led to some of the greatest public health achievements in history, including the worldwide eradication of naturally-occurring smallpox and the near-eradication of polio.

In addition, vaccines have contributed to significant reduction in the disease burden imposed by measles, mumps, hepatitis, influenza, diphtheria, and many other infections. The science of vaccinology is dynamic -- it unfolds as technology enables scientists to continue to create safer and more effective vaccines. Vaccine safety is an integral part of every aspect of vaccine development and evaluation.

Despite the rigorous evaluation process, in recent years some members of the public have raised concerns about potential relationships between vaccines and particular diseases or adverse events. A series of Institute of Medicine reviews (2001 to 2004) evaluated the state of the science for specific vaccine safety topics and recommended research activities to help address key areas.

Since that time, scientific research has advanced our knowledge in many areas. Because this knowledge continuously generates new questions and opens new avenues for exploration, NIH is interested in encouraging research to address important scientific questions relating to vaccine safety.

Examples of research topics include, but are not limited Detailed evaluation of various host immune/physiological responses to currently licensed vaccine antigens and/or adjuvant combinations Evaluation of existing childhood immunization schedules to optimize safe and long-term protective immune memory Studies that define the capacity and quality of the immune response throughout infancy and childhood.

Can vaccines be further optimized to minimize the need for secondary Identification of the molecular basis for differential immune/physiologic responses to vaccination at different stages of life or when underlying health problems exist Studies to determine if there ar e associations between genetic variations among individuals and susceptibility to serious adverse events in response to Identification of risk factors and biological markers that would allow for assessment of whether there is a relationship be tween certain diseases or disorders and licensed Comparison of the immunologic and physiologic effects of different combinations of vaccines and different schedules NOTE: The mechanisms/processes allowable for clinical trial support differ among Institutes.

Please contact the relevant Institute representative listed in Section VII Agency Contacts before submitting applications that include clinical research. (See NIAID Notice AI-05-021 at http://grants. nih.

gov/grants/guide/notice-files/NOT-AI-05-021. html ) See Section VIII, Other Information - Required Federal policies related to this announcement. FOA will use the Research Project Grant (R01) a ward mechanism.

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project. FOA uses Just-in-Time information concepts (see SF424 (R&R) Application 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 . 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 Facilities 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 response to III.

Eligibility Information 1. A.

Eligible Institutions following organizations/institutions are eligible to apply: Controlled Institutions of Higher Education Private Institutions of Higher Education Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions 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) Agencies of the Federal Government Faith-based or Community-based Organizations.

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). 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 require cost sharing as defined in the current NIH Grants Policy 3. Other-Special Eligibility Criteria a resubmission application, but such applications must include an Introduction addressing issues raised in the previous critique (Summary Statement) . Applicants may submit a renewal application.

may submit more than one application, provided that each application is Section IV. Application and Submission Information To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) 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: Grants. gov ( http://www.

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

nih. gov/ElectronicReceipt/preparing. htm ) 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 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.

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. CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.

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 find out if an organization is already Commons-registered, see the " List of Grantee Organizations Registered in NIH eRA Commons.

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 Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) 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.

PD/PI must 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 Internet Assisted Review (IAR) role, both roles should exist under one Commons account. 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. registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons. 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.

that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization.

Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government. 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 Request Application Information 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. assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected] .

for the hearing impaired: TTY 301-451-5936. all applications using the SF424 (R&R) application forms and in accordance (R&R) Application Guide for this FOA through Grants. gov/Apply .

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 . 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 & Related Project/Performance Site Locations Related Other Project Information Related Senior/Key Person Modular Budget or Research as appropriate (See Section IV. 6 . , Special Instructions , regarding appropriate required budget component.)

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: Prepare 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 specifications, which are based upon a standard U.S. paper size of 8.

5 x If appropriate, request funds for up to 8% Facilities and Administrative (F&A) costs (excluding equipment) ( see NOT-OD-01-028 , March 29, 2001); 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 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 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.

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). Involving a Single Institution all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Involving Multiple Institutions 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 3.

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

A. Submission, Review, and Date:September 5, 2008 (Earliest date an application may be submitted to 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 A letter of intent is not required for the funding 3. B.

Submitting an Application Electronically to the NIH 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 institution/organization) on the application due date(s).

(See Section 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: All registrations must be complete prior to the submission deadline The 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.

Any system identified errors/warnings must be corrected and the submission process completed within the error correction window. 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 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: Initial application submission must be on-time. The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.

Proof of on-time submission (e.g., Grants. gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application. 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.

everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the Division of Receipt and Referral, Center for Scientific Review, NIH, after two business days, excluding to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window.

This option should be used if the AOR/SO determines that warnings should be addressed or if information was lost or compromised during transmission. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two business days if no action is taken.

Please remember that some warnings may not be applicable or may need to be addressed after application submission. 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 did not transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.

gov system issue. 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 NIH 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 Center for Scientific Review, NIH.

Incomplete applications initiative is not subject to intergovernmental NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Pre-award costs are allowable.

A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval.

If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred.

NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement .

Submission Requirements and Information mechanisms/processes allowable for clinical trial support differ among Institutes. Please contact the relevant Institute representative listed in Section VII Agency Contacts before submitting applications that include clinical research. (See NIAID Notice AI-05-021 at http://grants.

nih. gov/grants/guide/notice-files/NOT-AI-05-021. html ) Credential (e.g., Agency Login) The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons.

This DUNS number must match the DUNS number provided at CCR registration with Grants. gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications .

Research Plan Component Sections All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following Instructions for Applications Requesting $500,000 (direct costs) or More per requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps: program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study; Obtain agreement