Psychosocial/Behavioral Interventions and Services Research in Autism Spectrum Disorders (R34) is sponsored by National Institutes of Health (NIH) (multiple institutes). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PA-07-343: Psychosocial/Behavioral Interventions and Services Research in Autism Spectrum Disorders (R34) 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 (NIMH), ( http://www.

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

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

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

nih. gov ) Neurological Disorders and Stroke (NINDS), ( http://www. ninds.

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

gov/ninr ) Title: Psychosocial/Behavioral Interventions and Services Research in Autism Spectrum Disorders (R34) Update: The following update relating to this announcement has been issued: July 29, 2011 - This PA has been reissued as PA-11-283. 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. 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) 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 weeks prior to the grant submission date.

See Section IV . Announcement (PA) Number: PA-07-343 of Federal Domestic Assistance Number(s) 93. 173, 93.

865, 93. 853, 93. 361 Release/Posted Date: March 28, 2007 Opening Date: April 2, 2007 ( Earliest date an application may be submitted to requires that applications be successfully submitted to Grants.

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

Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1. nih. gov/grants/funding/submissionschedule.

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

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

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

htm#reviewandaward Additional Information To Be Available Date (URL Activation Date): Not Applicable Expiration Date: March 17, 2010 Additional Overview Content Purpose.

This Funding Opportunity Announcement (FOA) provides resources to facilitate exploratory research on psychosocial/behavioral treatments for autism, as well as innovative services research, including the development of instruments to evaluate the impact of interventions on core features of autism spectrum disorders, and comorbid symptomatology.

It is intended to encourage research on: 1) the development and/or pilot testing of new or adapted interventions or instruments, 2) pilot testing interventions with preliminary efficacy data in larger clinical trials, or 3) innovative services research directions that require preliminary testing or Mechanism of Support. This FOA will utilize the NIMH R34 grant Available and Anticipated Number of Awards.

The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received. Budget and Project Period: The total project period for an application submitted in response to this funding opportunity may not exceed three years. Direct costs are limited to $450,000 over an R34 3-year period, with no more than $225,000 in direct costs allowed in any single year.

Eligible Organizations: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Small Business; For-Profit Organization (Other than Small Business); State Government; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Non-domestic (non-U.S.) Entity (Foreign Organization); Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Regional Organization; Other(s): Eligible agencies of the Federal government; Faith-based or community based organizations Investigators (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. Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

Application Research Strategy Length. The R34 application PHS398 Research Plan compo nent of the SF424 (Item 3) may not exceed 12 pages. Renewals and Resubmissions.

Applications can be renewed by competing for additional project periods. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). R34 grant support is for new projects only; competing renewal (formerly competing continuation) applications will not be accepted.

However, it is intended that grantees funded through this exploratory phase program will elect to seek continuing support for their projects through the R01 grant mechanism. Number of PDs/PIs. More than one PD/PI, or multiple PDs/PIs, may be designated on the application.

Application 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 instructions. General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web 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 is available at: TTY 301-451-5936.

Initial merit review convened by the ICs of the assigned Part I Overview Information Part II Full Text of Announcement Section I. Funding Opportunity Section II. Award Information 2.

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

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

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

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

Review and Selection Process A. Additional Review Criteria B. Additional Review Considerations D.

Sharing Research Resources 3. Anticipated Announcement and Award Dates Section VI. Award Administration 2.

Administrative and National Policy Requirements Section VII. Agency Contact(s) 1. Scientific/Research Contact(s) 2.

Peer Review Contact(s) 3. Financial/Grants Management Contact(s) Section VIII. Other Information - Required Federal Citations II - Full Text of Announcement Section I.

Funding Opportunity Description The purpose of this Funding Opportunity Announcement (FOA) is to facilitate exploratory research on psychosocial/behavioral treatments for autism, as well as innovative services research, including the development of instruments to evaluate the impact of interventions on core features of autism spectrum disorders, and comorbid symptomatology.

It is intended to encourage research on: 1) the development and/or pilot testing of new or adapted interventions or instruments, 2) pilot testing interventions with preliminary efficacy data in larger clinical trials, or 3) innovative services research directions that require preliminary testing Exploratory grants for intervention and services research are designed to support the early phases of intervention development or adaptation, protocol development and preliminary pilot testing to support a later full-scale (e.g., R01) efficacy or effectiveness study, and innovative services research.

For the purpose of intervention development or pilot testing, "intervention" is defined as psychosocial/behavioral approaches to treat disorder; efforts to prevent co-morbid symptoms and disorders; efforts to reduce residual symptoms and/or enhance functioning; efforts to target provider behavior change; or system organizational efforts to improve care quality, coordination or delivery.

In terms of innovative services research, pilot studies might include explorations of the use of approaches and concepts new to a particular substantive area, research and development of new techniques, or initial research to develop a body of data upon which significant future research may be built (i.e., potential for high impact).

Integrated treatment and services strategies should consider the timing and sequencing of these strategies, as well as the development of incremental outcome measures that could reflect cumulative effects of multiple interventions. Outcomes may be defined at the individual, group, system, or population levels, or any of these in combination.

In February 2003, Congress requested that the Department of Health and Human Services (DHHS) develop a set of autism research goals and activities for the next several years (House Report 109-10).

Subsequently, the federal Interagency Autism Coordinating Committee (IACC) convened a panel of autism investigators with a range of scientific expertise, as well as community members, to assess the field of autism research and identify roadblocks that may be hindering progress in understanding its causes and best treatment options.

In collaboration with this panel of experts, the IACC developed a matrix for short- and long-term goals toward determining the causes and effective treatments for autism. The final matrix was officially presented to Congress in the Congressional Appropriations Committee Report on the State of Autism Research (April 2004).

Included in the matrix are goals for development and dissemination of interventions that address the core symptoms of infants and toddlers at risk for, or identified with, autism spectrum disorders; and development and dissemination of interventions to optimize functioning of older children, adolescents and adults Additionally, the National Institute of Health convened working groups of investigators to evaluate the roadblocks to research on psychosocial interventions for autism.

The working groups concluded that although there is preliminary data supporting a number of psychosocial/behavioral interventions for autism, there are few randomized controlled trials of efficacy, and virtually no studies of implementation in the community.

Roadblocks to conducting such research include few manualized interventions for replication or for multi-site clinical trials, and few instruments that have been demonstrated to be sensitive to change in autism symptomatology. For a summary of the September 2002 NIH-sponsored working group meeting on psychosocial/behavioral interventions in autism, please see http://www. nimh.

nih. gov/scientificmeetings/autismconference. cfm The published summaries of the working groups findings may be found through the following citations: Lord et al.

(2005). Challenges in evaluating psychosocial interventions for autistic spectrum disorders. Journal of Autism and Developmental Smith et al.

(2006). Designing research studies on psychosocial interventions in autism. Journal of Autism and Developmental Disorders , e-pub: Aug.

02, 2006 . Research suggests that early intervention can result in significant improvements for some children with autism, although for how many children and for how much gain has varied considerably across findings.

There is currently no universally accepted medical or biological treatment for the core features of autism, and the primary source of intervention for most children is through their families or through the educational system. The deficits in basic skills that define autism, the pervasiveness of these deficits across contexts, and the early onset of the disorder, also affect the design of treatments.

As these children transition into adulthood, resources for treatment dramatically diminish, and there is a paucity of research addressing interventions across the lifespan in autism. In addition, there are few integrated theories of how treatment effects are mediated, which has resulted in little knowledge about how and why improvements are observed.

There is a need for treatment studies which are designed to contribute to a greater program of knowledge accumulation, beyond whether a particular treatment is more effective than another within a particular sample.

This expectation requires attention to replicability, including treatment manuals, standard subject selection and links between theory and Some examples of research topics related to intervention that may be addressed under this FOA include, but are not limited to: refine and/or validate specific existing psychosocial/behavioral interventions for individuals with autism. psychosocial/behavioral treatment approach with another.

Studies that relate phenotypic characteristics of individuals with autism to Studies of the relationship between family variables and treatment outcome.

Research examining the effects of psychosocial/behavioral intervention on parents and families of children Studies on the general ization or transfer of learning from one setting to Research on feasibility of psychosocial/behavioral intervention in various settings from the perspective of stakeholders (e.g., clients/patients, families, providers, to validate outcome measures that are sensitive to treatment effects, generalize across settings (e.g., from treatment setting to school, home, etc), and which can be used to assess intervention outcomes across activities and task demands.

most effective manner in which to integrate developmental and other approaches with behavioral methods. Studies examining the relationship between specific target behaviors and theoretically-based predictions of changes in general development (i.e., research addressing the degree to which interventions impact target behaviors above and beyond expected maturation effects).

Research examining psychosocial/behavioral treatments in under-represented populations, such those living in rural areas, or non-English speaking individuals with Studies seeking to translate findings from research on basic behavioral and neurobiological processes (e.g., cognition, attention, emotion) into applied interventions.

Studies examining the utility of new, adapted, or existing psychosocial/behavioral intervention approaches for addressing psychiatric comorbidities (e.g., Research focusing on basic design issues, such as those dealing with confounding effects of pharmacologic treatments in behavioral treatment trials, those comparing levels or intensity of intervention; those comparing single subject, small group, and/or large group approaches; and those utilizing cross-sectional and/or longitudinal approaches.

Research utilizing pooled-data, or research designs that yield data which could be Studies seeking to shift from efficacy trials (whether the intervention works in ideal circumstances) to effectiveness research (whether the intervention works in the real world).

establish manualization and dissemination of a psychosocial/behavioral Examples of research topics on services for persons with autism spectrum disorders across the lifespan (including adult and geriatric populations) include, but are not limited to: Studies on the organization of services, the process and receipt of care, and related health economics at the individual, clinical, program, community, system, and cross-systems levels in specialty health, general health, and other delivery sy stems, such as the school system and workplace.

Studies to measure the quality and outcomes of care for persons with autism spectrum disorders, including diagnostic, treatment and rehabilitative services. Research using qualitative and/or quantitative approaches to examine factors that impede (i.e., barriers) or facilitate access to services.

Preliminary studies to examine the clinical epidemiology of autism spectrum disorders across all clinical and VIII, Other Information - Required Federal Citations , for policies related This Funding Opportunity Announcement (FOA) mechanism. The applicant will be solely responsible for planning, directing, and executing the Just-in-Time information concepts.

It also uses the modular as well as the non-modular budget formats (see http://grants. nih. gov/grants/funding/modular/modular.

htm ). Specifically, if you are a U.S. organization and 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 3. 4, Modular Budget Component, of the Application Guide).

applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096 , grant support is for new projects only; competing renewal (formerly competing continuation) applications will not be accepted.

However, it is intended that grantees funded through this exploratory phase program will elect to seek continuing support for their projects through the R01 grant mechanism. Applicants may submit a resubmission, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement) . this FOA, applicants for the R34 award may request direct costs of up to $450,000 for three years.

Although variations from year to year are permissible, in no case may any year be more than $225,000 in direct costs, and total direct costs for the entire project period may not exceed $450,000. Grant applications may request one, two, or three years of support. grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004 , III. Eligibility Information 1.

A.

Eligible Institutions You may submit an application(s) if your institution/organization has any of the following characteristics: Public/State Controlled Institution of Higher Educa tion Private Institution of Higher Education Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education) Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education) For-Profit Organization (Other than Small Business) Indian/Native American Tribal Government (Federally Indian/Native American Tribal Government (Other than Indian/Native American Tribally Designated Organiz ation Non-domestic (non-U.S.) Entity (Foreign Organization) Hispanic-serving Institution Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Hawaiian Serving Institutions Other(s): Eligible agencies of the Federal government; Faith-based or community based organizations 1.

B. Eligible Individuals Any individual 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, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does 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 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 single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project.

Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, 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 PD/PIs will be factored into the assessment of the overall scientific merit of the application.

Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.

nih. gov/grants/multi_pi . 2.

Cost Sharing or Matching This program does not require cost sharing as defined in the current NIH Grants Policy Statement . Applicants may submit more than one application, provided each application is scientifically distinct. 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, link to http://www. grants. gov/applicants/apply_for_grants.

jsp 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 eRA Commons.

additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows: Organizational/Institutional Registration in Grants. gov/Get Registered 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 CCR registration. The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.

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

- 9:00 p. m. Eastern Time 2) Organizational/Institutional Registration in the eRA Commons To find out if an organization is already Commons-registered, see 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 Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) The individual(s) designated as PDs/PIs on the application must also be registered 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.

Each 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.

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

the PD/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 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 1. Request Application Information 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 2. Content and Form of Application Submission all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide ( MS 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 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 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: SF424 (R&R) (Cover component) Research & Related Project/Performance Site Research & Related Other Project Information Research & Related Senior/Key Person PHS398 Cover Page Supplement Modular Budget or Research & Related Budget, as appropriate (See Section IV. 6 .

, Special Instructions, regarding appropriate required budget component.) & Related Budget (required for foreign applications) Research & Related Subaward Budget Attachment(s) 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 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 . 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 Policy 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 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 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 All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of 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, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan.

In the event of an award, the requested allocations may be reflected in a footnote on the Applications Involving a Single When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Applications Involving Multiple 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 3. 4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component. 3.

A. Submission, Review, and Anticipated Start Dates Opening Date:April 2, 2007(Earliest date an application may be Application Submission/Receipt Date(s): Standard dates apply, please see http://grants. nih.

gov/grants/funding/submissionschedule. htm 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 A letter of intent is not required for the funding 3. B.

Submitting an Application Electronically to the To submit an application in response to this FOA, applicants should access this FOA via http://www. grants. gov/applicants/apply_for_grants.

jsp and follow steps 1-4. Note: Applications must only be submitted electronically . PAPER APPLICATIONS WILL NOT BE ACCEPTED.

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