Investigator Initiated Multi-Site Clinical Trials (Collaborative R01) is sponsored by National Heart, Lung, and Blood Institute (NHLBI). This funding opportunity supports investigator-initiated multi-site randomized controlled clinical trials addressing any research question related to the mission and goals of the NHLBI.

Expired PAR-10-096: Investigator Initiated Multi-Site Clinical Trials (Collaborative R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services National Institutes of Health (NIH), ( http://www.

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

nih. gov ) Title: Investigator Initiated Multi-Site Clinical Trials (Collaborative R01) This Funding Opportunity Announcement (FOA) is a reissue of PAR-07-373 . Update: The following updates relating to this announcement have been issued: March 1, 2013 - This PAR has been reissued as PAR-13-128.

June 3, 2011 - See Notice NOT-HL-11-146 Modification of Introduction Requirements for Resubmissions. September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011.

August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time.

See NOT-OD-10-123 . Announcement (PA) Number: PAR-10-096 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 BE SUBMITTED IN PAPER FORMAT. in conjunction with the application guidelines included with this announcement for Grants (hereafter called Grants.

gov/Apply). is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV .

Domestic Assistance Number(s) 93. 233, 93. 837, 93.

838, 93. 839 5, 2010 (Earliest date an application may be submitted to Grants. gov) Letters of Intent Receipt Date(s): Not Applicable On-time submission requires that applications be successfully submitted to Grants.

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

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

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

htm#AIDS . 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 Information To Be Available Date (URL Activation Date): Not Applicable Expiration Date: May 8 , 201 3 Purpose . The purpose of this Funding Opportunity Announcement is to provide a vehicle for submitting grant applications for investigator-initiated multi-site Phase II or Phase III randomized, controlled clinical trials.

The trials may address any research question related to the mission and goals of NHLBI and may test clinical or behavioral interventions. Investigators should consult the NHLBI's Guidelines for Investigator Initiated Clinical Trials ( http://www. nhlbi.

nih. gov/funding/policies/clinical. htm ) for more detailed instructions and information about multi-site clinical trial grant applications.

interests of the NHLBI can be found at NHLBI's website ( http://www. nhlbi. nih.

gov/index. htm ). Funding Opportunity Announcement is not intended for support of single-center studies or multi-center observational studies that are not of Support.

This FOA will utilize the NIH Research Project Grant (R01) award mechanism. Awards may be converted by NHLBI to cooperative agreements (U01). Funds Available and Anticipated Number of Awards.

The total amount awarded and the number of awards will depend upon the numbers, quality, duration, and costs of the applications received. Awards issued under this FOA are contingent upon the availability of funds. Budget and Project Period.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award Application Research Strategy Component Length: The R01 application Research Strategy section of the PHS398 may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. See Table of Page Institutions/Organizations.

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

Include individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the 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).

See new NIH policy on resubmission (amended) applications ( NOT-OD-09-003 , NOT-OD-09-016 ). may submit a renewal application. Application Materials.

See Section IV. 1 for application materials. General Information.

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

htm 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 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 4. Intergovernmental Review 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 Description purpose of this Funding Opportunity Announcement is to provide a vehicle for submitting grant applications for investigator initiated multi-site (Phase II or Phase III) randomized, controlled clinical trials. The trials may address any research question related to the mission and goals of NHLBI and may involve clinical or behavioral interventions.

The trials may rando mize at the individual (patient) level or at a group level (e.g., randomization of cli nics, schools, worksites, etc.) . clinical trials are trials that recruit study subjects from two or more geographically distinct enrollment sites, or centers. The sites are usually distinct in other characteristics (e.g. demographic, socioeconomic, or clinical).

Subjects are randomized and study protocols are followed at these sites. should consult NHLBI's Guidelines for Investigator Initiated M ulti-Site Clinical Trials for more information about multisite clinical trial grant applications ( http://www. nhlbi.

nih. gov/fund ing/policies/clinical. htm ).

Funding Opportunity Announcement is not intended for support of single-center studies or multi-center observational studies that are not testing an intervention. See http://grants1. nih.

gov/grants/guide/search_results. htm? scope=pa-rfa&year=active&text_curr=clinical+trials for other clinical trial FOAs.

support of multi-site clinical trials is one strategy NHLBI uses t o improve the understanding of the clinical mechanisms of disease and to improve prevention, diagnosis, and treatment. For interests of the NHLBI, applicants are encouraged to consult t he NHLBI web site ( http://www. nhlbi.

nih. gov/inde x. htm ) Objectives of this research program The proposed research must address a scientifically important question, must provide valuable information to the e xisting knowledge base, and must have public health applicability.

Research topics should be based on the NHLBI's national program plan areas of heart, lung, and blood diseases, and sleep The proposed experimental approach should include a randomized design and clear description of the study population, subject eligibility an d inclusion/exclusion criteria; recruitment and enrollment plans; methods of randomization; primary and secondary endpoints and outcome measures; treatment and any follow-up procedures.

Statistical methods should be proposed that are appropriately matched to the study design and include sample size and power calculations, plans for analyses, and data management and quality control For group - randomized designs, an entire group (such as an entire clinic, school, etc.) is randomly assigned to the intervention or control/comparison condition.

Studies with a group-randomized design should indicate eligibility and inclusion/exclusion criteria for the group to be randomized. Since data are collected on individuals who are in the randomized group, appropriate statistical approaches for the hierarchical nature of the data must be employed. The information provided in the application should be organized in a manner that will facilitate peer review.

The body of the application must present an overview of the state of the science, current status and relevance of the trial, a discussion of the specific protocol, and the approach to data collection and analys is. The following sections must be included in the research p lan of the application: Specific Aims: (1 page) The specific aims of the trial must be clearly and concisely presented.

These should include a clear specification of the primary and major secondary endpoints to be measured, with a clear differentiation of the importance of various endpoints. sections comprise the Research Strategy and must not exceed 12 pages Significance: The significance of the proposed clinical trial must be clearly stated. It is particularly important that there be a discussion of how the trial will test the hypothesis proposed.

The application should make clear the need for the study with emphasis on how the results will advance our knowledge of theory and practice in this area. A discussion of the costs and benefits of the study should be included for evaluation of the trial's significance. Innovation: Explain how the application challenges and seeks to shift current research or clinical practice paradigms.

Approach: The studies that led to the proposed clinical trial should be presented. Data from pilot studies which show the need for and the feasibility of the trial should also be presented. Additional supporting data from other research should be included so that the approach chosen is clearly justified.

Conceptualization and planning must have progressed to a stage sufficient to allow for an overall assessment of the likelihood of the success particular design chosen; a clear description of the study population including the characteristics of this population and why it is an appropriate group to answer the question posed, discussion of the specific protocol, and the approach to data collection and analysis.

A list of subject eligibility and inclusion/exclusion criteria; or of group eligibility criteria for group-randomized trials. R ecruitment and enrollment plans, including a discussion of the availability of subjects for the proposed study and the ability of enrollment centers to recruit and retain the proposed number of subjects, including women and minority subjects and data supporting recruitment and retention estimates.

For group-randomized trials attention to recruitment of the groups as well as the subjects within the groups is needed. A pproaches to be used for retention, cooperation and follow up of subjects and to address any anticipated changes in the composition of the study population over the M ethods of randomization.

D etailed description of the intervention to be tested D escriptions of all clinical, laboratory, physiological, and/or behavioral tests to enable the research questions to be answered. P otential biases or challenges in the research protocol proposed and how they will be addressed.

Data Management and Quality Control: Describe the approach to data management including methods for monitoring the quality and consistency of the intervention(s) and data collection; policies and methods for ensuring blinding of study results; data confidentiality and subject privacy.

Statistical Methods: The statistical section should describe sample size and power calculations, linking the calcula tions to the primary and secondary endpoints, the hypotheses to be tested, methods of data preparation and presentation, and data analysis plans and methods appropriate to the level of randomization. Include prototypes of data collection forms in the appli cation.

Requirement for separate Data Coordinating Center All multi-site randomized controlled trials with direct costs of $500,000 or more (excluding consortium F&A costs) in any year must include plans to submit at least two applications, on e of which is for the support of a Clinical Coordinating Center (CCC) and the other which is for support of a Data Coordinating Center (DCC).

If a separate application for a Data Coordinating Center (DCC) is included details of the data management, qualit y control and statistical methods should be included Optional separate applications for core functions Separate applications for core functions e.g. reading centers, quality of life/economic analyses, imaging centers may be submitted, but are not required.

Separate applications for cores should only be submitted if it is scientifically and administratively more efficient and reasonable to have a separate grant award for the core function than, for example, to use a subcontract or fee-for-service agreement under the CCC or the DCC. Justification for separate core applications must be provided.

The principal investigator for the DCC or the core application cannot be involved in (and cannot be a principal investigator on) any other award associated with the trial.

For the purposes of peer review and funding, the DCC, core applications and any other applications submitted as part of the same trial will be considered as a cluster, and each application will receive an identical cluster impact/priority score and Study Organization and Administration The application must describe the organization of the study and how the trial will be managed.

A description of the role of any internal or external advisory committees, including the data and safety monitoring committee must be included. Note that trials that are converted to Cooperative Agreements (U01s) will have a DSMB appointed by The oversight, responsibilities, and coordination of any centers or cores proposed must be discussed .

The application must describe any sub-contracts or service agreements for personnel or facilities and include in the application documentation of their commitment, co-signed by a business official and the scientific director at the participating center. A timetable for completion of the various stages of the trial must be included.

The overall clinical trial must be directed by an investigator with experience in the conduct of clinical trials and expertise in the content area of the trial. Such experience must be carefully documented. Biographical sketches for all key investigators must be provided.

Most clinical trial designs will require a Each center or core proposed must have a director desi gnated. The experience of each director must be carefully documented. In addition, the authority of each center or core director within the study must be specified.

Clinical, data management, and laboratory facilities and required equipment should be described in detail for all participating institutions . As of October 2000 ( http://grants. nih.

gov/grants/guide/notice-files/NO T -OD-00-039. html ), NIH implemented a policy requiring education on the protection of human research participants for all key personnel submitting applications for grants or proposals for contracts or receiving new or non-competing awards for projects involving human research participants.

Applicants should refer to Part II of the SF424 Application Guide "Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan." Assurances of the protection of human participants and the biohazard safety of employees (if applicable) must be provided both for the overall study and for individual field sites. The applicant must discuss any issues which might lead to concern for the welfare of participants.

Master templates of the clinical protocol and forms to be used to obtain informed consent must be included in an appendix. At a minimum, the human subjects sections of data coordinating center applications must address data security measures and Data Monitoring (and Safety) Plan As of the October 2000 receipt date ( http://grants. nih.

gov/gran ts/guide/notice-files/NOT-OD-00-038. html ) , applicants must include a Data and Safety Monitoring (DSM) Plan for all clinical trials that is commensurate with the risk level of the proposed clinical research.

All applications or study protocols must include a general description of the monitoring plan, policies, procedures, responsible entities, and approaches to identifying, managing and reporting reportable events (adverse events and unanticipated problems), to the applicable regulatory agencies (e.g., Institutional Review Board [[ IRB ] ), the NHLBI/NIH, the Office of Biotechnology Activities, Office of Human Research Protections, the Food and Drug Administration, and the Data and Safety Monitoring Board (if one is used) .

The NHLBI Data and Safety Monitoring Policy dated October 31, 2008 is described at ( www. nhlbi. nih.

gov/funding/policies/dsmpolicy. htm ) .

T he DSM Plan must address the Who will manage and conduct the monitoring Proposed monitoring time points Where the monitoring will occur How the reportable events will be managed an d reported How sites/centers, and participating facilities (labs, pharmacies) will be monitored NIH requires the establishment of Data and Safety Monitoring Boards (DSMBs) for multi-site clinical trials involving interventions that entail potential risk to participants ( http://grants.

nih. gov/grants/guide/notice-files/not98-084. html ).

The purpose of this board is to provide independent advice to NHLBI concerning scientific issues pertaining to subject safety, data quality, study conduct and study continuation. In monitoring safety in the trial, the board also may recommend termination in the event of early significance of findings or futility, or the determination of unacceptable adverse effects.

The DSMB is normally appointed by the NHLBI for studies funded by Cooperative Agreements and consists of individuals who are not associated with the institutions participating in the trial. Potential members of this board should NOT be na med in the application. making an award for an Investigator-Initiated Clinical Trial, NHLBI will routinely consider the desirability of substantial continued staff involvement in a supportive mode.

If such i nvolvement is deemed appropriate by the Institute, the award mechanism will b e a cooperative agreement (U01) . Regardless of the mechanism of support, NHLBI staff will closely monitor progress during the award. This monitoring will include submission of the IRB approved protocol to the NHLBI Program Official, adequate serious adverse event management and reporting, adequate accrual monitoring plans (at http://www.

nhlbi. nih. gov/funding/policies /accrual_guidelines.

htm ) , and regular communications with the principal investigator and staff, and may include attendance at the steering committee, data and safety monitoring board, and related Terms and Conditions for an award for a clinical trial will include recruitment milestones expected to be met by the study as a whole at specific time periods, accrual goals for women and minorities (as appropriate), any requirements regarding minimum effort of specific key personnel, and any other identified requirements for completion of the approved research.

As with any award, continuation, even during the period recommended for support, is conditional upon satisfactory progress. If, at any time, recruitment falls significantly below the projected milestones for recruitment, the NHLBI will consider ending support and negotiating a phase-out of the award.

The NHLBI retains, as an option, periodic external peer review of See Section VIII, Other Information - Required Federal Citations , for policies related to this FOA will use the R01 award mechanism. The Project Director/Principal Investigator (PD/PI) will be for planning, directing, and executing the proposed project.

Pending awardees will be notified if the proposal will be awarded as a cooperative "Just-in-Time" information concepts (see SF424 (R&R) Application Guide ) . It also uses the modular as well as the non-modular budget formats (see http://grants. nih.

gov/grants/funding/modular/modular. htm ). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component . the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004 . NIH grants policies as described Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. III.

Eligibility Information 1. A.

Eligible Institutions organizations/institutions are eligible to apply: Controlled Institutions of Higher Education Institutions of Higher Education Historically Black College s and Universities (HBCUs) Tribally Controlled Colleges Alaska Native and Native Hawaiian Serving with 501(c)(3) IRS Status (Other than Institutions of Higher Education) without 501(c)(3) IRS Status (Other than Institutions 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 Non-domestic (non-U.S.) Entities (Foreign Eligible Agencies of the Federal Government Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application for projects that require a "team science" approach and therefore clearly do not fit the single-PD/PI model.

Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants. nih. gov/grants/multi_pi .

All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era. nih. gov/ElectronicReceipt/preparing.

htm for instructions). The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below.

When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically.

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

gov/grants/multi_pi . program does not require cost sharing as defined in the current NIH Grants 3. Other-Special Eligibility Criteria 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 new NIH policy on resubmission (amended) applications ( NOT-OD-09-003 , 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. submit a renewal application.

applications >$500K in direct costs (combined across all applications for the same trial) in any one year are limited to one resubmission. Introduction and response to reviewer's critiques should be integrated such that an identical Introduction is provided for each application that is part of this time, it is anticipated that this FOA will be reissued.

Renewals (formerly "competing continuation") applications will be accepted at the receipt dates of this and subsequent reissuances. 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. 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 ) PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons. additional separate actions are required before an applicant can submit an electronic application, as follows: Organizational/Institutional Registration in Grants.

gov/Get Registered Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants. gov registration process. If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time.

A valid TIN or EIN is necessary for CCR registration. The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days. Direct questions regarding Grants.

gov registration to: Business Hours: M-F 7:00 a. m. - 9:00 p.

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

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

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

hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account. When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization.

PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons. This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons. and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

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) forms. 1.

Request Application Information download the SF424 (R&R) application forms and the 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. assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected] . for the hearing impaired: TTY: (301) 451-5936 Content and Form of Application Submission applications using the SF424 (R&R) application forms for this FOA through Grants.

gov/Apply and in accordance with the SF424 (R&R) Application Guide ( http://grants. nih. gov/grants/funding/424/index.

htm ). Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH ( e.g., the "Credential" log-in field of the "Research & Related Senior/Key Person Profile" component must contain the PD/PI's assigned eRA Commons User ID ).

Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see "Frequently Asked Questions Application Submission of Grant Applications ." application has several components.

Some components are required, others are optional. The forms package associated with this FOA in Grants. gov/APPLY includes all applicable components, required and optional.

A completed application in response to this FOA includes the data in the following Project/Performance Site Locations Research & Related Other Project Information Research & Related Senior/Key Person PHS398 Cover Page Supplement PHS398 Modular Budget or Research & Related Budget , as appropriate (See Section IV. 6 . , " Special Instructions ," regarding appropriate required budget component.)

Research & Related Subaward Budget Attachment(s) Organizations ( Non-domestic [non-U.S.] Entities) policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants. nih. gov/grants/policy/nihgps_2003/NIHGPS_Part12.

htm#_Toc54600260 . from Foreign organizations must: Request budgets in U.S. dollars. detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms not the PHS398 Modular Budget component)( see NOT-OD-06-096 ).

Not include any charge-back of customs and import Comply with the format specifications, which are based upon a standard U.S. paper size of 8. 5" x 11" within each PDF. If appropriate, request funds for up to 8% Facilities and Administrative (F&A) costs (excluding equipment) (see NOT-OD-01-028 , March 29, 2001).

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").

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.

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

PD/PI Leadership Plan: For applications