Selected Topics in Transfusion Medicine (R21)

Selected Topics in Transfusion Medicine (R21) is sponsored by National Heart, Lung, and Blood Institute (NHLBI) / National Institutes of Health (NIH). This funding opportunity encourages research grant applications from investigators who propose to study topics that will determine blood banking and transfusion practice, aiming to improve the safety and availability of the blood supply and minimize transfusion risks.

Expired PAR-10-033: Selected Topics in Transfusion Medicine (R21) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Participating Organizations of Health (NIH), ( http://www.

nih. gov ) Participating Organizations Lung, and Blood Institute (NHLBI) ( http://www. nhlbi.

nih. gov ) Title: Selected Topics in Transfusion Update: The following update relating to this announcement has been issued: November 23, 2012 - This PAR has been reissued as PAR-13-025. September 6, 2011 - See Notice NOT-HL-12-101.

NHLBI Announces Changes in the Application Receipt Dates. 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 . 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. Announcement (PA) Number: PAR - 10-033 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.

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).

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 . Domestic Assistance Number(s) Opening Date: January 16 , 2010 (Earliest date an application may be submitted to Grants.

gov) of Intent Receipt Date(s): N/A NOTE: On-time submission requires that applications be successfully submitted to Grants. gov no later than 5:00 p. m.

local time (of the applicant institution/organization). Application Due Date(s): (New Date February 16, 2012 (new), March 16, 2012 (resubmission, revision) May 7, 2012 (AIDS), October 16, 2012 (new), November 16, 2012 (resubmission, revision), January 7, 2013 (AIDS) per NOT-HL-12-101 ), Original Date: Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm AIDS Application Due Date(s): N/A Date(s): (New Date June/July 2012, February/March 2013 per NOT-HL-12-101 ), Original Date: Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward Date(s): (New Date October 2012, May 2013 per NOT-HL-12-101 ), Original Date: Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward Anticipated Start Date(s): (New Date December 2012, July 2013 per NOT-HL-12-101 ), Original Date: Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward To Be Available Date (URL Activation Date): Not Applicable Expiration Date: January 8, 2013 issued by the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) , encourages research grant applications from investigators who propose to study topics that will determine blood banking and transfusion practice.

The National Heart, Lung, and Blood Institute (NHLBI) is responsible for supporting research in blood banking and transfusion medicine.

This research aimed at improving the safety and availability of the blood supply and the practice of transfusion medicine is critical to public health since about five million patients receive blood transfusions every year in the U.S. Since blood transfusions pose infectious and non-infectious risks to recipients, it is important to understand the determinants of transfusion-associated adverse events and how best to mini mize transfusion risks.

It is also crucial to maintain an adequate blood supply by minimizing the risks associated with the donation process and developing enhanced recruitment and retention Mechanism of Support. This FOA will use the NIH Explora tory/Developmental (R21) grant mechanism and runs in parallel with a FOA of identical scientific scope, PA R - 10- 034 which encourages applications under the R01 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 mechanism, numbers, quality, duration, and costs of the Period.

The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. R21 application Research Strategy section of the PHS398 may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts.

See Table of Page Limits . Eligible Institutions/Organizations. Institutions/organizations liste d in Section III, 1.

A. are eligible to apply. Eligible Project Directors/Principal Investigators (PDs/PIs).

Individuals with the skills, knowledge, and resources necessary to carry out the proposed 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 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 ). Renewals. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted.

Materials. See Section IV. 1 for application materials.

All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the current forms and general information on SF424 (R&R) Application and Electronic Submission, (R&R) Application and Electronic Submission Information: http://grants. nih. gov/grants/funding/424/index.

htm General information on Electronic Submission of Grant Applications: http://era. nih. gov/ElectronicReceipt/ 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 Submission 1. Request Application Information 2. Content and Form of Application Submission 3.

Submission Dates and Times A. Submission, Review, and B. Submitting an Application Electronically to the NIH C.

Application Processing Other Submission Requirements Section V. Application Review Information 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 2. Administrative and National Policy Requirements 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 This FOA issued by the National Heart, Lung, and Blood Institute (NHLBI) , National Institutes of Health (NIH), encourages research grant applications from investigators who propose to study topics in blood banking and transfusion medicine aimed at improving the safety and availability of the blood supply and the practice of transfusion transfusion medicine and blood banking is critical to public health in the U.S. since transfusion therapy is the most commonly employed, and arguably least understood procedure in the U.S. affecting about five million recipients every year.

Blood transfusions potentially expose recipients to transmissible biologic agents that are known or suspected to be associated with specific disorders. These agents range from major known threats such as human immunodeficiency virus (HIV), Hepatitis C virus (HCV), and Hepatitis B (HBV) to novel or emerging agents of public health concern such as Dengue virus or the agents causing babesiosis and malaria.

Because of increasing travel and immigration, new emerging infectious agents will periodically threaten the U.S. blood supply. Blood transfusions also pose non-infectious risks to recipients.

Some of these risks are poorly understood and include transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), alloimmunization, metabolic and coagulation abnormalities, microchimerism, and transfusion-related immunomodulation (TRIM).

It is important to conduct research to understand how best to enhance blood collection, and the laboratory screening and processing of blood products, as well as characterize the immunologic, inflammatory and vasoactive properties of transfusions. It is also vital to determine which patients will truly benefit from transfusions.

Finally, it is essential to maintain an adequate blood supply by better understanding the motivations and barriers to donation, minimizing donation risks, and developing improved recruitment and retention programs.

Findings from this research will benefit the five million patients who receive blood products every year in the US; in particular, the chronically transfused patients such as those with sickle cell disease or thalassemia who are at higher risk of developing transfusion-associated complications.

Large populations who will benefit include trauma victims, cancer patients, patients undergoing orthopedic and cardiovascular surgery, and patients admitted to intensive care units. Further, research aimed at minimizing the risks associated with donating and enhancing the donation experience will benefit the five percent of the U.S. population who donate blood every year.

Research efforts aimed at enhancing recruitment and retention will also help assure a safe and adequate blood supply. In order to be appropriate to this FOA, applications must have a clear and direct link to advancing the field and/or the practice of blood banking and transfusion medicine.

The research must be pertinent to the donation of, and/or transfusion of, red blood cell units, platelet units, granulocyte units, cryoprecipitate, and/or plasma (such as fresh frozen plasma and 24 hour plasma) units manufactured per US standards . Basic, animal model, early human physiological, epidemiological, comparative effectiveness, and behavioral research projects can be proposed.

Large clinical trials are not appropriate to Examples of research topics appropriate for this FOA include, but are not limited to, those listed below. Blood donor motivations and deterrents. Novel donor recruitment and retention strategies including targeted interventions to recruit underrepresented Strategies to optimize the donation environment and enhance donor coping skills and satisfaction.

studies to promote blood donor health. Evaluation of blood donor risk factors. Safety and availability implications of changes in blood donor health/behavioral screening protocols.

Evaluation of new strategies to enhance blood collection and processing such as new additive solutions or new Studies to evaluate donor laboratory screening/confirmatory testing methodologies and algorithms and their impact on transfusion safety and availability. Use of novel methods to safeguard the blood supply including research on pathogen reduction and nitrosylation.

Infectious complications of blood transfusion including known, and novel or emerging agents of concern. Non-infectious complications of blood transfusion including for example, alloimmunization and its consequences, transfusion-related acute lung injury (TRALI), metabolic, hemostasis and coagulation abnormalities, transfusion-related immunomodulation (TRIM), microchimerism, and graft versus host disease.

Immunomodulatory, inflammatory and vasoregulatory properties of transfused blood components including platelet, red blood cell, plasma, and/or granulocyte products. Studies of the storage lesion components and their associations with transfusion-associated adverse events. Development of effective animal models to study transfusion complications Blood product utilization patterns.

Comparative effectiveness studies of various transfusion practices Evaluation of the impact of introducing a new blood product preparation (e.g., pathogen-reduced apheresis platelets), modified product, or treatment strategy on transfusion-associated adverse events and recipients clinical outcomes.

Studies designed to measure frequency and characteristics of blood product shortages and impact, if any, on Studies that characterize the risks, benefits, and clinical outcomes of prophylactic versus therapeutic transfusion strategies, and alternatives to allogeneic transfusions.

are not appropriate for this FOA are : carrying red blood cell substitutes and research on products derived from plasma such as coagulation factors or immunoglobulin products. Research on hematopoietic stem cells and their progenitors. Research on in vitro production of red blood cells or other blood components The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view.

These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.

The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area.

These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism.

For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.

Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism. Information on the R03 program can be found at http://grants. nih.

gov/grants/funding/r03. htm . See Section VIII, Other Information - Required Federal Citations , for policies related This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism .

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project. Just-in-Time information concepts see SF424 (R&R) Application Guide ) . It also uses the modular as well as non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement .

Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5. 4, Modular Budget Component, of the Application Guide).

foreign applicants must complete and submit budget requests using the Research & Related Budget component. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Although the financial plans of the Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total project period for an application submitted in response to this funding opportunity may not exceed 2 years.

Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.

Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. F&A costs requested by consortium participants are not included in the direct cost limitation.

See NOT-OD-05-004 , November 2, 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 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) Eligible Agencies of the Federal Government Faith-based or Community-based 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. 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 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 . does not require cost sharing as defined in the current NIH Grants Policy Statement . of Applications.

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

Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See http://grants. nih.

gov/grants/guide/notice-files/NOT-OD-09-003. html and NOT-OD-09-016 . Original new and competing renewal applications that were submitted prior to January 25, 2009 are 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. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted.

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: 1. 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: Grants. gov Customer Support 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 designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants. gov. The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization.

This account cannot have any other role attached to it other than the PD/PI. This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Commons. Both the PD/PI and AOR/SO need separate accounts 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 SF424 (R&R) Application Guide for this FOA through Grants. gov/Apply .

Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA. For further assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected] .

Telecommunications for the hearing impaired: TTY and Form of Application Submission using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide ( MS (R&R) Application Guide is critical to submitting a complete and accurate application to NIH.

There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/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 Guide, Electronic Submission of Grant Applications . application is comprised of data arranged in separate components. Some components are required, others are optional.

The forms package associated with this FOA in Grants. gov/APPLY will include all applicable components, required and optional.

A completed application in response to this FOA will include the following components: Research & Related Project/Performance Site Research & Related Other Project Information Research & Related Senior/Key Person PHS398 Cover Page Supplement PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV. 6.

Special Instructions, regarding appropriate required budget Research & Related Subaward Budget Attachment(s) Organizations (Non-domestic [non-U.S.] Entities) 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% Facilities and Administrative (F&A) costs (excluding equipment) ( see NOT-OD-01-028 , March 29, Comply with Federal/NIH policies on human subjects, animals, and biohazards; and with Federal/NIH biosafety and biosecurity regulations (see Section VI. 2 .

, Administrative and National Policy Requirements ) 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.

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 Information 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.

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

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) 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 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 5. 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 Anticipated Start Dates Date: January 16, 2010 (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 Peer Review Date(s): Standard dates apply, please see http://grants1.

nih. gov/grants/funding/submissionschedule. htm#reviewandaward 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 letter of intent is not required for the funding opportunity.

3. B. Submitting an Application Electronically to the application in response to this FOA, applicants should access this FOA via http://www.

grants. gov/Apply and follow Steps 1-4. Note: Applications must only be submitted electronically .

PAPER APPLICATIONS WILL NOT BE ACCEPTED. 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 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.