NEI Early-Stage Dissemination and Implementation Research in Communication Sciences and Disorders (R03 Clinical Trial Optional)

NEI Early-Stage Dissemination and Implementation Research in Communication Sciences and Disorders (R03 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH/National Institute on Deafness and Other Communication Disorders). Supports early-stage research in hearing, balance, taste, smell, voice, speech, and language; arts organizations could partner for sensory art dissemination projects related to taste and smell perception.

Expired PAR-06-520: Dissemination and Implementation Research in Health (R03) This notice has expired. Check the NIH Guide for active opportunities and notices. Part I Overview Information Department of Health and Human Services National Institutes of Health (NIH), ( http://www.

nih. gov/ ) Components of Participating Organizations of Mental Health (NIMH), ( http://www. nimh.

nih. gov/ ) National Cancer Institute (NCI), ( http://cancer. gov/ ) National Institute on Drug Abuse (NIDA), ( http://www.

nida. nih. gov/ ) National Institute on Deafness and Other Communication Disorders (NIDCD), ( https://www.

nidcd. nih. gov/ ) Office of Behavioral and Social Science Research (OBSSR), ( http://obssr.

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

nih. gov/ ) National Institute on Alcohol Abuse and Alcoholism (NIAAA), ( http://www. niaaa.

nih. gov/ ) National Institute of Dental and Craniofacial Research (NIDCR), ( http://www. nidcr.

nih. gov/ ) Office of Dietary Supplements (ODS), ( http://dietary-supplements. info.

nih. gov/ ) Title: Dissemination and Implementation Research in Health (R03) of PAR-06-071 , which was previously released November 14, 2005. Update: The following update relating to this announcement has been issued: December 1, 2009 - This PA has been reissued as (PAR-10-039).

May 29, 2009 - See Notice NOT-OD-09-104Error Correction Window Extended for Electronic Submission of NIH Opportunities with Due Dates Between May 20 and May 29, 2009. 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) APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT. This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.

gov/Apply for Grants (hereafter called Grants. gov/Apply). A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date.

See Section Program Announcement (PA) Catalog of Federal Domestic Assistance 93. 242, 93. 393, 93.

361, 93. 173, 93. 279, 93.

837, 93. 273, Release/Posted Date: August 10, 2006 Opening Date: August 10, 2006 (Earliest date an application may be submitted to Grants. gov) Letters of Intent Receipt Date(s): 08/22/2006 , 04/24/2007, 12/28/2007, 08/25/2008, 4/22/2009 requires that applications be successfully submitted to Grants.

gov no later than 5:00pm local time (of the applicant institution/organization).

Application Submission/Receipt Date(s): 09/22/2006 , 05/24/2007, 01/24/2008, 09/24/2008, 05/22/2009 AIDS Application Submission/Receipt Date(s): 01/02/2007 , 09/01/2007, 05/01/2008, 01/02/2009, 09/01/2009 Peer Review Date(s): 02/2007, 10/2007, 06/2008, 02/2009, 10/2009 Council Review Date(s): 05/2007, 1/2008, 09/2008, 05/2009, 01/2010 Earliest Anticipated Start Date(s): 07/2007, 04/2008, 12/2008, Additional Information To Be Available Date (Url Expiration Date: September 2, 2009 This funding announcement opportunity (FOA) encourages investigators to submit research grant applications that will identify, develop, and refine effective and efficient methods, structures, and strategies that test models to disseminate and implement research-tested health behavior change interventions and evidence-based prevention, early detection, diagnostic, treatment, and quality of life improvement services into public health and clinical practice settings.

FOA will use the NIH Small Research Grant (R03) award mechanism and runs in parallel with an FOA of identical scientific scope, PAR-06-521 , that solicits applications under the Exploratory/Developmental Research Grant (R21) mechanism.

R03 grant mechanism supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new R03 is intended to support small research projects that can be carried out in a short period of time with limited resources. The R03 is not renewable.

and Project Period : Budgets for direct costs of up to $50,000 per year and a project duration of up to two years may be requested for a maximum of $100,000 direct costs over a two-year Organizations : For-profit organizations; non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State and local governments; eligible agencies of the Federal government; domestic or foreign institutions/organizations; faith-based or community-based organizations; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); and Indian/Native American Tribally Designated Organization.

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 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.

may submit more than one application, provided each application is See Section IV. 1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites: http://grants.

nih. gov/grants/funding/424/SF424_RR_Guide_General_Ver2. doc (MS Word) http://grants.

nih. gov/grants/funding/424/SF424_RR_Guide_General_Ver2. pdf (PDF) information on SF424 (R&R) Application and Electronic Submission, see the (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/ for the hearing impaired is available at: TTY 301-451-5936. II Full Text of Announcement I.

Funding Opportunity Description III. Eligibility Information 2. Cost Sharing or Matching 3.

Other - Special Eligibility Criteria IV. Application and Submission Information 1. Request Application Information 2.

Content and Form of Application Submission 3. Submission Dates and Times A. Submission, Review and Anticipated Start Dates B.

Submitting an Application Electronically to the NIH C. Application Processing 4. Intergovernmental Review 6.

Other Submission Requirements V. Application Review Information 2. Review and Selection Process A.

Additional Review Criteria B. Additional Review Considerations D. Sharing Research Resources 3.

Anticipated Announcement and Award Dates VI. Award Administration Information 2. Administrative and National Policy Requirements 1.

Scientific/Research Contact(s) 2. Peer Review Contact(s) 3. Financial/Grants Management Contact(s) VIII.

Other Information - Required Federal Citations Section I. Funding Opportunity Description Each year, billions of U.S. tax dollars are spent on research and hundreds of billions are spent on service delivery programs.

However, relatively little is spent on, or known about, how best to ensure that the lessons learned from research inform and improve the quality of health and human services and the availability and utilization of evidence-based approaches.

The National Institutes of Health have recognized that closing the gap between research discovery and program delivery is both a complex challenge and an absolute necessity if we are to ensure that all populations benefit from the Nation’s investments in new scientific The National Institute of Mental Health (NIMH), the National Cancer Institute (NCI), the National Institute on Drug Abuse (NIDA), the National Institute on Deafness and Other Communication Disorders (NIDCD), the Office of Behavioral and Social Science Research (OBSSR), the National Institute of Nursing Research (NINR), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Dental and Craniofacial Research (NIDCR), and the Office of Dietary Supplements (ODS) invite grant applications for research that will identify, develop, and refine effective and efficient methods, structures, and strategies that test models to disseminate and implement research-tested health behavior change interventions and evidence-based prevention, early detection, diagnostic, treatment, and quality of life improvement services into public health and clinical practice settings.

The purpose of this dissemination and implementation research program announcement (FOA) is to support innovative approaches to identifying, understanding, and overcoming barriers to the adoption of evidence-based interventions that previous efficacy or effectiveness research has shown to be effective, but where adoption to date has been limited or Most researchers who propose to develop and test disease control interventions either explicitly or implicitly intend to promote efficacious interventions to the broader population from which the efficacy study sample was drawn or the public health or clinical practice settings in which the intervention was originally tested.

Thus, for many years, health researchers may have assumed that an intervention deemed efficacious within clinical or community-based trials would be easily transmitted to the field; evidence suggests that this has not been the case.

Moreover, little is known about effective approaches to overcome barriers to adoption of evidence-based Recent literature has underscored the importance of understanding the many factors that affect whether the public health or clinical practice communities will use a given intervention.

Invited research on dissemination will address how information about health promotion and care interventions is packaged, transmitted, and interpreted among a variety of important stakeholder groups. Research on implementation will address the level to which health interventions can fit within real-world public health and clinical service systems.

The goals of this FOA are to encourage trans-disciplinary teams of scientists and practice stakeholders to work together to develop and/or test conceptual models of dissemination and implementation that may be applicable across diverse practice settings, and design studies that will accurately assess the outcomes of dissemination and This FOA addresses priorities laid out in a number of reports including: The Road Ahead: A Report by the National Advisory Mental Health Council's Services Research and Clinical Epidemiology Workgroup ( http://www.

nimh. nih. gov/council/TheRoadAhead.

pdf ); Translating Behavioral Science into Action: A Report of the National Advisory Mental Health Council's Behavioral Science Workgroup ( http://www. nimh. nih.

gov/publicat/nimhtranslating. pdf ); Designing for Dissemination Conference Summary Report ( http://cancercontrol. cancer.

gov/d4d/info. html#conferences ); Diffusion and Dissemination of Evidence-based Cancer Control Interventions ( http://www. ahcpr.

gov/clinic/epcsums/canconsum. htm ); National Institute on Drug Abuse Blue Ribbon Task Force Report on Services Research ( http://www. drugabuse.

gov/about/organization/nacda/HSRReport. pdf ). For additional resources on dissemination research please visit http://cancercontrol.

cancer. gov/d4d . For additional information on dissemination and implementation research in blood diseases, http://www.

nhlbi. nih. gov/resources/docs/index.

htm#blood , and for the reports on sickle cell disease, http://www. nhlbi. nih.

gov/meetings/scdmtg/execsum. htm and http://www. nhlbi.

nih. gov/meetings/workshops/conscd. htm , may be useful.

Dissemination and implementation research intends to bridge the gap between public health, clinical research, and everyday practice by building a knowledge base about how health information, interventions, and new clinical practices are transmitted and translated for public health and health care service use in specific settings. Unfortunately, there continues to be great variation in how these terms are used.

Dissemination and implementation have both been used to represent the complete process of bringing "evidence" into practice, originally defined as "diffusion."

While using the terms dissemination and implementation to cover such a wide area can be very helpful in facilitating discussion, it does not allow for the division of this very complex diffusion process into smaller, more easily addressed research questions that can develop a robust knowledge base. We are inviting applications that will begin to break down the complexity of bridging research and practice.

For the purpose of this FOA, we make a distinction between "dissemination" and "implementation." is the targeted distribution of information and intervention materials to a specific public health or clinical practice audience. The intent is to spread knowledge and the associated evidence-based interventions.

is the use of strategies to adopt and integrate evidence-based health interventions and change practice patterns within specific settings. This distinction needs to be made because interventions developed in the context of efficacy and effectiveness trials are rarely transferable without adaptations to specific settings.

Therefore, research is needed to examine the process of transferring interventions into local settings, settings that may be similar to but also somewhat different from the ones in which the intervention was developed and tested.

We are currently missing critical information about how, when, by whom, and under what circumstances research evidence spreads throughout the agencies, organizations, and front line workers providing public health and clinical services.

As a necessary prerequisite for unpacking how information can lead to treatment or service changes, we need to understand how and why information on mental health, drug abuse, and other disease treatments may or may not reach many different stakeholders. We need to understand what underlies the creation, transmission, and reception of information on evidence-based psychopharmacological, behavioral, and psychosocial interventions.

Successful dissemination of health information (including information about underutilized interventions) may occur quite differently depending on whether the audience consists of consumers, caregivers, practitioners, policymakers, employers, administrators, or other stakeholder groups.

Moving the field forward will require studies identifying mechanisms and approaches to package and convey the evidence-based information necessary to improve public health and clinical care services.

Previous efforts in dissemination research have often assumed that interventions can be transferred into any service setting without modification and that a unidirectional flow of information (e.g., publishing a guideline) is sufficient to achieve practice change.

"Success" of the transfer has been largely assessed based on structural measures (such as counts of personnel or contacts) or patient outcome measures that do not specifically assess how the intervention was implemented or whether the implementation remained faithful to the original conceptualization and intent of the intervention.

We need the field to develop a knowledge base about "how" interventions are transported to real-world practice settings, which is likely to require more than the dissemination of information about the interventions.

This research announcement encourages theory-driven studies to test conceptual frameworks around the implementation process that move away from an exclusively "top-down" approach to a greater emphasis on the resources of local care settings and the needs of multiple Dissemination and Implementation research needs to involve both interdisciplinary cooperation and trans-disciplinary collaboration, utilizing theories, empirical findings, and methods from a variety of fields not traditionally associated with health research.

Relevant fields include: information science, clinical decision-making, organizational and management theory, finance, individual and systems-level behavioral change, public health, business administration, statistics, anthropology, learning theory, and marketing.

Meaningful research will include collaboration with stakeholders from multiple public health and/or clinical practice settings as well as consumers of services and their families/social networks. Research Issues: Listed below are examples of topics supported by this program announcement for dissemination and implementation research. The list is illustrative, not exhaustive.

It is expected that investigators responding to this FOA will identify other important research areas.

of factors influencing the creation, packaging, transmission and reception of valid health research knowledge, ranging from psychological and socio-cultural factors affecting individual practitioners, consumers, primary caregivers and other stakeholder groups to investigations addressing large service delivery systems and funding sources.

studies to test the effectiveness of individual and systemic dissemination strategies, focusing on outcomes related to the direct outcomes of the strategies (e.g., acquisition of new knowledge, maintenance of knowledge, attitudes about the dissemination strategies, use of knowledge in practice of systemic interventions to impact organizational structure, climate, culture, and processes to enable dissemination and implementation of clinical information and effective clinical interventions.

of efforts to implement prevention, early detection, and diagnostic interventions, as well as treatments or clinical procedures of demonstrated efficacy into existing care systems to measure the extent to which such procedures are utilized, and adhered to, by providers and consumers.

of the capacity of specific care delivery settings (primary care, schools, community health settings, etc.) to incorporate dissemination or implementation efforts within current organizational forms. that focus on the development and testing of theoretical models for dissemination and implementation processes.

on the fidelity of implementation efforts, including the identification of components of implementation that will enable fidelity to be assessed of outcome measures and suitable methodologies for dissemination and implementation approaches that accurately assess the success of an approach to move evidence into practice (i.e., not just clinical outcomes).

and follow-up studies on the factors that contribute to the sustainability of research-based improvements in public health and clinical practice. testing the utility of alternative dissemination strategies for service delivery systems targeting rural, minority, and/or other underserved Studies on how target audiences are defined, and how evidence is packaged for specific target audiences.

VIII, Other Information - Required Federal Citations , for policies related Section II. Award Information This Funding Opportunity Announcement (FOA) will use the NIH Small Research Grant (R03) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses the modular budget formats (see the Modular Applications and Awards Grants Policy Statement . All applications submitted in response to this FOA must use the modular budget format.

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 (formerly competing continuation ) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed small grant application may be submitted.

See NOT-OD-05-046 , April 29, 2005. about the R03 programs, see: http://grants. nih.

gov/grants/funding/r03. htm . 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 and the receipt of a sufficient number of meritorious project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each).

Commensurate Facilities and Administrative (F&A) costs are allowed. F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004 , November 2, 2004 Section III.

Eligibility Information 1. A.

Eligible Institutions You may submit (an) application(s) if your organization has any of the following characteristics: Public or private institutions, such as universities, colleges, hospitals, and laboratories Units of State government Units of local government Faith-based or community-based Indian/Native American Tribal Government (Federally Recognized) Indian/Native American Tribal Government (Other than Federally Recognized) Indian/Native American Tribally 1.

B. Eligible Individuals skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (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.

2. Cost Sharing or Matching This program does not require cost sharing as defined in the current NIH Grants Policy Statement . Applicants may submit more than one application, provided each application is scientifically distinct.

IV. Application and Submission Information To download an Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, 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/GetStarted ) NIH 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 . Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as 1) Organizational/Institutional Registration in Grants.

gov/Get Your organization will need to 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 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 Contact Center Phone: 800-518-4726 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 the " List of Grantee Organizations Registered in NIH eRA Commons. Direct questions regarding the Phone: 301-402-7469 or 866-504-9552 (Toll Free) Business hours M-F 7:00 a.

m. 8:00 p. m.

Eastern Time 3) Project 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 This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view Note 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 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 institution is already registered in both Grants. gov and the Commons . The NIH will accept electronic applications only from organizations that have completed all Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.

gov/Apply . Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the Attachment files may be useable for more than one FOA.

For further assistance contact GrantsInfo, Telephone 301-710-0267, Email: [email protected] . Telecommunications for the hearing impaired: TTY of Application Submission Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide ( MS Word or PDF ). The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH.

There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH ( e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/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 The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.

gov/APPLY will include all applicable components, required and optional.

A completed application in response to this FOA will include the following components: Research & Related Project/Performance Site Locations Research & Related Senior/Key Person PHS398 Cover Page Supplement Research & Related Subaward Budget Attachment(s) Form Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R03 uses ONLY the PHS398 Modular Budget.

(Do not use the detailed Research & Related Budget.) Several special provisions apply to applications submitted by foreign organizations: Charge back of customs and import fees is not allowed. Format: Every effort should be made to comply with the format specifications which are based upon a standard U.S. paper size of 8.

5 x 11 within each PDF. administrative costs (excluding equipment) may be requested. See NOT-OD-01-028 , Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.

Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI. 2.

, Administrative and National Additional information regarding foreign grants is available in the NIH Grants Policy Statement . 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 or that augment existing U.S. resources. 3.

Submission Dates and Times See Section IV. 3. A for details.

Submission, Review and Anticipated Start Dates Opening Date: August 10, 2006 (Earliest date an application may be submitted to Grants.

gov) Letters of Intent Receipt Date(s): 08/22/2006, 04/24/2007, 12/28/2007, 08/25/2008, 04/22/2009 Application Submission/Receipt Date(s): 09/22/2006, 05/24/2007, 01/24/2008, 09/24/2008, 05/22/2009 AIDS Application Submission/Receipt Date(s): 01/02/2007, 09/01/2007, 05/01/2008, 01/02/2009, 09/01/2009 Peer Review Date(s): 02/2007, 10/2007, 06/2008, Council Review Date(s): 05/2007, 1/2008, 09/2008, 05/2009, Earliest Anticipated Start Date(s): 07/2007, 04/2008, 12/2008, 07/2009, 04/2010 applicants are asked to submit a letter of intent that includes the following Descriptive title of proposed Name, address, and telephone number of the Principal Investigator Names of other key personnel Participating institutions 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 at the beginning of this The letter of intent should be sent to: Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7133, MSC 9631 Telephone: (301) 443-3747 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/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 applicant institution/organization) on the application submission/receipt date(s).

(See Section IV. 3. A.

for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not Once an application package has been successfully submitted through Grants.

gov, any 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 business days to view the application image. If 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 Prior 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.

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.

If 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.

If 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 the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.

Both 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 two days. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will be an acknowledgement of receipt of applications from Grants.

gov and the Commons . Information related to the assignment of an application to a Scientific Review Group is also in the Commons. The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application.

The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants. nih.

gov/grants/policy/policy. htm . 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 or competing renewal 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 or competing renewal award.

The 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 NIH Grants Policy Statement http://grants. nih.

gov/grants/policy/nihgps_2003/NIHGPS_Part6. htm . The NIH requires the PD/PI 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 component.

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 Registration FAQs Important Tips -- Electronic Submission Renewal (formerly competing continuation or Type 2 ) applications are not permitted.

application instructions outlined in the SF424 (R&R) Application Word or PDF ) are to be followed, with the following requirements for R03 applications: R03 applications will use