Investigator-initiated Program Project Grant (P01)

Investigator-initiated Program Project Grant (P01) is sponsored by National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health. This FOA encourages investigator-initiated Program Project Grant (P01) applications from institutions/organizations in the broad areas of biomedical imaging and bioengineering, enabled by relevant areas of the physical sciences, engineering, computer sciences, information scienc…

Expired PAR-10-233: National Institute of Biomedical Imaging and Bioengineering Program Project (P01) Applications This notice has expired. Check the NIH Guide for active opportunities and notices. Part I Overview Information Department of Health and Human Services Institutes of Health (NIH), ( http://www.

nih. gov ) Components of Participating Organizations Institute of Biomedical Imaging and Bioengineering (NIBIB), ( http://www. nibib.

nih. gov ) Institute of Biomedical Imaging and Bioengineering Program Project (P01) Update: The following update relating to this announcement has been issued: February 9, 2011 - See Notice NOT-EB-11-003 Effective May 8, 2011, the NIBIB will no longer accept new applications for this PAR.

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants. gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://grants.

nih. gov/grants/guide/notice-files/NOT-OD-06-035. html .

NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts ( http://grants. nih. gov/grants/guide/index.

html ). Program Announcement (PA) Number: PAR-10-233 Catalog of Federal Domestic Intent Receipt Date(s): 30 days before the receipt date. Application Submission Dates(s): Standard dates apply; please see http://grants.

nih. gov/grants/funding/submissionschedule. htm Application Submission Dates(s): Standard dates apply; please see http://grants1.

nih. gov/grants/funding/submissionschedule. htm#AIDS apply; please see http://grants1.

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

nih. gov/grants/funding/submissionschedule. htm#reviewandaward Anticipated Start Date: 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 Purpose .

This FOA, issued by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Insitutes of Health, encourages investigator-initiated Program Project Grant (P01) applications from institutions/organizations in the broad areas of biomedical imaging and bioengineering enabled by relevant areas of the physical sciences, engineering, computer sciences, information science, and the medical and life sciences.

P01 grants are to support broad-based multidisciplinary research programs, which have a well-defined major objective or central theme, but which are addressing a range of imaging or bioengineering questions in contrast to the traditional research project (R01). Proposed program projects may address any of the broad areas of imaging and bioengineering research supported by the Institute.

A description of the NIBIB scientific program areas can be found at http://www. nibib1. nih.

gov/Research/ProgramAreas . Mechanism of Support. This FOA supports the NIH Program Project (P01) grant mechanism.

The P01 mechanism is designed for research in which the funding of several independent projects as a group offers significant scientific advantages over support of the same projects as individual research grants. An NIBIB P01 application requires a minimum of three interrelated research projects and the component projects must share a common central theme, focus, and overall objective. Anticipated Number of Awards.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications Budget and Project Period .

Budgets for direct costs per year will depend upon specific project requirements, and a project duration of up to five years may be requested. The expected direct cost for program project awards is $1. 2-1.

4 million per year for most studies within the scope of this FOA. Application Research Strategy Length: The P01 Program Overview section may not exceed 12 pages, each Individual Research Project may not exceed 12 pages, and each Shared Research Core may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. Institutions/Organizations.

Institutions/ organizations 1. A. are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). I ndividuals 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 support.

Number of PDs/PIs. Only one PD/PI may be designated on the application. Number of Applications.

A Principal Investigator may not submit more than one application per due date. 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. Hearing Impaired.

Telecommunications for the hearing impaired are available at: TTY (301) II Full Text of Announcement I. Funding Opportunity Description III. Eligibility Information 2.

Cost Sharing or Matching 3. Other - Special Eligibility Criteria Application and Submission Information 1. Address to Request Application Information 2.

Content and Form of Application Submission 3. Submission Dates and Times A. Receipt and Review and B.

Sending an Application to 4. Intergovernmental Review 6. Other Submission Requirements Application Review Information 2.

Review and Selection Process 3. Anticipated Announcement and Award Dates Administration Information 2. Administrative and National Policy Requirements 1.

Scientific/Research Contact(s) 2. Peer Review Contact(s) 3. Financial/ Grants Management Contact(s) Information - Required Federal Citations - Full Text of Announcement Section I.

Funding Opportunity This Funding Opportunity Announcement (FOA), issued by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), encourages grant applications for investigator-initiated Program Project Grants (P01) in all areas of biomedical imaging and bioengineering supported by the Institute (see http://www. nibib1. nih.

gov/Research/ProgramAreas for a description of NIBIB’s scientific research programs) .

include but are not limited to: Biomaterials, Biomedical Informatics, Drug and Gene Delivery Systems and Devices, Image-Guided Interventions, Image Processing, Visual Perception and Display, Magnetic, Biomagnetic and Bioelectric Devices, Magnetic Resonance Imaging and Spectroscopy, Mathematical Modeling, Simulation and Analysis, Medical Devices and Implant Science, Micro-biomechanics, Micro- and Nano-Systems, Platform Technologies, Molecular Imaging, Nanotechnology, Nuclear Medicine, Optical Imaging and Spectroscopy, Rehabilitation Engineering, Sensors, Structural Biology, Surgical Tools, Techniques and Systems, Telehealth, Tissue Engineering, Ultrasound (diagnostic and interventional), and X-ray, Electron, and Ion Beam Technologies.

mechanism is designed to support integrated, multiproject research programs involving a number of independent investigators who share knowledge and common resources while working towards a unifying overall goal. Basic, translational, early-stage clinical, and/or population-based studies are appropriate. The P01 is a highly competitive grant and the NIBIB funds very few of these grants each year.

Successful NIBIB program projects generally bring together investigators in engineering, mathematics, informatics, and the physical and life sciences to apply complementary approaches to a common theme. The leader of the overall P01 is called the Principal Investigator (PI); the leaders of the subprojects in a P01 are called subproject leaders. The PI of the P01 must devote a minimum of 3.

0 person months (25% effort) to the grant. The PIs of the subprojects must devote a minimum of 2. 4 person months (20% effort) to the subproject(s) for which they serve as leader.

If multiple principal investigators or co-leaders are used then each must devote a minimum of 1. 2 person months (10% effort) to the subproject. A P01 requires a minimum of three research subprojects led by three independent subproject leaders or co-leaders.

One of the subprojects must be led by the P01 Principal Investigator. There can only be one overall PI but subprojects are allowed to have co-leaders (multiple subproject leaders on a single subproject). Collectively, these subprojects should demonstrate essential elements of unity and interdependence and result in a greater contribution to program goals than would occur if each subproject were pursued individually.

Each individual subproject should reflect a self-standing, scientifically meritorious, research effort (individual subprojects of the P01 can also be submitted as R01 applications); however, the individual subprojects should be clearly interrelated and synergistic so that the research ideas, efforts, and outcomes of the program as a whole will offer a distinct advantage over pursuing the individual projects separately.

In addition to individual research subprojects, applicants may propose one or more Shared Resource Core if needed for the proposed research. Each Shared Resource Core must provide support for at least two of the proposed research subprojects. The Cores should consist of some service, technique, or instrumentation that will enhance the research endeavors, consolidate manpower effort, and contribute to cost effectiveness and quality.

Administrative Cores are also allowed. Core support may include personnel, equipment, supplies, services, and facilities required for the integration of the subprojects toward their central research Information - Required Federal Citations , for policies related to this opportunity announcement (FOA) will use the Program Project (P01) grant award mechanism.

The applicant will be solely responsible for planning, directing, and executing the proposed project. FOA uses Just-in Time information concepts. It also uses non-modular budget formats described in the PHS398 application instructions (see http://grants.

nih. gov/grants/funding/phs398/phs398. html ).

Program Project Grants in the NIBIB compete for funding with all other grant mechanisms. There is no set-aside budget for P01s. Budgets for direct costs per year will depend upon specific project requirements, and a project duration of up to five years may be requested.

The expected direct cost for program project awards is $1. 2-1. 4 million per year for most studies within the scope of this FOA.

Under certain circumstances, with the advanced concurrence of NIBIB staff, additional funds may be requested and provided for major pieces of equipment. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Although the financial plans of the NIBIB provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA . 1.

A.

Eligible Institutions organizations/institutions are eligible to apply: Controlled Institutions of Higher Education Institutions of Higher Education Hispanic-serving Institutions Historically Black Colleges and Universities Tribally Controlled Colleges and Universities Alaska Native and Native Hawaiian Serving Institutions with 501(c)(3) IRS Status (Other than Institutions of Higher Education) without 501(c)(3) IRS Status (Other than Institutions of Higher Education) Organizations (Other than Small Businesses) American Tribal Governments (Federally Recognized) American Tribally Designated Organizations Housing Authorities/Indian Housing Authorities Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government Faith-based or Community-based Organizations.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. However, such institutions may participate as members of consortia or subcontractors on the application. 1.

B. Eligible Individuals individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her 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 2.

Cost Sharing or Matching require cost sharing as defined in the current NIH Grants Policy 3. Other-Special Eligibility Criteria of Applications. A Principal Investigator may not submit more than one application for a given receipt date.

The Program Project PI must devote a minimum of 3. 0 person months (25% effort) to the program including serving as the leader of a component subprojects. Component subproject leaders must devote a minimum of 2.

4 person months (20% effort) to their subproject. If the subproject uses multiple leaders (equivalent to multiple PIs on an R01), the minimum effort devoted by each multiple PI must be at least 1. 2 person months (10% effort).

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.

may submit a renewal application . Section IV. Application and Submission Information 1.

Address to Request Application application instructions are available at http://grants. nih. gov/grants/funding/phs398/phs398.

html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected] .

the hearing impaired: TTY 301-451-5936. 2. Content and Form of Application Submission applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide ( http://grants.

nih. gov/grants/funding/phs398/phs398. html ).

must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www. dnb.

com/us/ . The D&B number should be entered on line 11 of the face page of the PHS 398 form. number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box information is available in the PHS 398 grant application instructions .

Supplemental Instructions for the Preparation of Multi-Project Applications . applications submitted in response to this FOA, the standard PHS 398 instructions are modified as summarized below. These additional instructions are required because the PHS Form 398 is designed primarily for individual freestanding research project grant applications, and does not have specific instructions for multi-project applications.

- Face Page : Include the number and title of this FOA in item/line 2 of the PHS 398 application face page. - Description, Performance Sites, and Key Personnel: Under Description, state the proposed programs broad, long-term objectives, specific aims, and the significance to the field of Biomedical Imaging and/or Bioengineering.

Define the relevance of each proposed subproject and shared resource core to the overall theme and goals of the program. List all performance sites and all Key Personnel and Other Significant Contributors for the entire P01, beginning with the PI/PD and then listing all other Key Personnel alphabetically.

Include all project and core leaders, co-leaders, co-investigators, and consultants and consortium collaborators (if applicable and if these individuals will devote measurable effort to the project). - Table of Contents: Modify the PHS 398 Form Page 3 to enable reviewers to find each component of the application easily.

and 5 Detailed Budget for Initial Budget Period; Budget for Entire Proposed Period of Support: Prepare a detailed composite budget for all requested support categories for the first years using Form Page 4 and a summary budget for the entire proposed period of support using Form Page 5 of the PHS 398 application. Prepare detailed and summary budgets for individual subprojects and shared cores as well.

If applicable, provide additional budget pages pertaining to Consortium/Contractual arrangements (following the standard PHS 398 instructions). Sketches: Compile all biographical sketches after the Overall Budget, starting with the PD(s)/PI(s) followed by all other investigators in alphabetical order. Do not repeat biographical sketches in the individual research projects or shared resources cores.

Overview section should summarize the overall research plan for the multi-project P01 application. Page limits for each section are given below. The sections of the Program Overview are as follows: Introduction to the Overall Application : (resubmission applications only; one-page limit ) must address the previous peer review critique (Summary Statement).

Overall Program Goals and Specific Aims : ( one-page limit ) summarize the overall theme, goals, specific aims, and expected impact of the proposed program on one or more broad fields of biomedical imaging and bioengineering.

Overall Research Strategy : ( 12 page limit excluding references and the list of publications that resulted from work in the program during the current funding period (for renewal Summarize the overall research strategy, including the unifying, central theme to which each component subproject relates and research investigator contributes.

Describe the overall goals, significance, innovation, approaches, preliminary studies and progress (for competing renewal applications) of the program as a whole. Examples of previous collaborations that may have led to the goals of the proposed work should be presented.

Also include Overall Program Integration and Management Explain how the proposed projects and shared resource cores (if proposed) will be coordinated and work together to address the overall goals and aims of the program more effectively than if the projects were done independently. Explain the plans for organizational and administrative management of the overall program, and for coordination and communication within the program.

Explain the methods that will be used for monitoring progress in the projects and effective use of the shared resource cores. Include a proposed schedule of seminars, monthly group meetings, and semi-annual retreats as well as other activities intended to promote close communication and Briefly summarize the overall institutional environment, resources, and commitments relevant to effective implementation of the P01.

Describe how the proposed projects and shared resource cores will use the facilities and resources available at the overall program level. Describe how the program as a whole will benefit from any special equipment, laboratories, patient populations, and collaborations.

Organization and Administrative Structure of the P01 as a Whole: Describe how the administrative structure would be organized to foster interactions among investigators and accelerate the pace of research. Include information on the chain of responsibility, external and internal advisory boards, specific managerial responsibilities, consortium arrangements, and designation of replacement for PI.

The external advisory board should consist of two to five advisors committed to the evaluation of the program by written documentation. New P01 grant applications should not constitute their external advisory board prior to or during the review of their application because individuals either invited or named to this group would not be able to serve as peer reviewers of the application.

The internal advisory board should consist of three to five members outside of the program but within the same institution, or within a neighboring institution, who are able to assist in ongoing reviews on a more Summary of Progress for Renewal Applications: Renewal applications must include a progress report highlighting P01 achievements since the last competitive review.

Separate progress reports are required for each subproject and core unit in other sections of the application. This composite summary/progress report must brief summary of major accomplishments attributable to the project grant and a brief explanation of how these accomplishments contributed to furthering the stated objectives of the program.

list of all published, in press and submitted (not "inpreparation") manuscripts resulting from the P01 grant. These publications must acknowledge NIBIB P01 funding. list of changes, if any, in the professional staffing since the last competitive review.

list of subprojects and core units, in tabular form, that have been discontinued, modified, or completed since the last competitive review, identified by number and title, with a brief explanation list of subprojects and core units in the current program, with the amount of current funding for each and the requested funding forthe first budget period of each subproject and core unit that would be each as a "new" or "continuing" component.

following table summarizes the page limits for the various sections of the to the Overall Application (for resubmission applications only). Program Goals and Specific Aims Individual Research Subprojects: Each P01 program project application must include at least three individual (albeit connected) research subprojects each of which is pertinent to the central theme of the program.

There is no requirement that the component subprojects be located at a single institution, however, it is incumbent upon the applicant to make clear how component subprojects and cores would function across institutions. Subproject leaders are expected to devote at least 2. 4 person months (20% effort) to each subproject for which they serve as leader.

If multiple principal investigators are used, each must devote a minimum of 1. 2 person months (10% effort). It is expected that most of the subproject leaders will be investigators with significant research experience and fully established at their institutions.

Each research subproject should be prepared according to the standard PHS 398 instructions as modified below. The overall format and page limits for an R01 application apply to each subproject. However, instead of the standard PHS 398 face page for each subproject, create a title page that lists the subproject number, the name of the subproject, and the name of the subproject leader(s).

Do not repeat biographical sketches included at the beginning of the application. For each individual subproject, page limits are 1 page for the Introduction in Resubmission or Revision applications, if applicable, 1 page for Specific Aims and 12 pages for the Research Strategy portion. Each subproject must have a designated subproject PI or multiple PIs.

Each individual subproject of a program project grant should represent both an independent and an interdependent research effort. Subprojects may be technology development or hypothesis-driven basic, translational or applied research or a combination of technology development and hypothesis-driven research. The subprojects must include Introduction: For Resubmission or Revision Application only ( one page limit ).

Specific Aims: State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved ( one Research Strategy : The research plan for each subproject is limited to 12 pages . The relationship of the goals of each component subproject to the central theme of the Program should be described.

Additional information concerning collaboration and integration between subprojects and cores and the contribution of each component to the program's specific goals should be succinct and must be included within the 12 pages. Unnecessarily long, wordy, or confusing presentations are usually perceived as indicative of premature or poorly planned research.

If Core facilities are included, the technical/scientific and fiscal relationship of each component subproject to each core should be described. The bibliography is not counted toward the 12-page limitation per subproject. Applications exceeding the page limitation or using inappropriate fonts or margins will be review.

Measure the printed page for font compliance before submission. Preliminary Studies for New Applications: Refer to PHS form 398 Instructions for Progress Reports for Renewal/Revision Applications : For renewal/revision applications, provide a Progress Report as part of the Approach section. Provide the beginning and ending dates for the period covered since the last competitive review.

Summarize the specific aims of the previous subproject period and the importance of the findings, and emphasize the progress made toward their achievement. Explain any significant changes to the specific aims and any new directions including changes resulting from significant budget reductions.

The following table summarizes the page limits for the various sections of the Subprojects: to the Subproject (for resubmission applications only). may propose one or more (as needed) appropriate shared technical or administrative shared resource cores.

These shared resources must not duplicate analogous resources already established in the applicant institutions (although supplemental funding to such existing resources may be requested). Each shared resource core should be prepared according to the standard PHS 398 instructions as modified below.

Instead of the standard PHS 398 face page for each shared resource core, create a title page that lists the shared resource core number, the name of the shared resource core and the name and academic title of the shared resource core director and each participating investigator. Do not repeat biographical sketches included at the beginning of the application. Specific Aims should not exceed one page .

The page limit for the description of the Core is 6 pages . The description must present clearly the facilities, techniques, and professional skills that the Core unit would provide. As justification for the Core unit, briefly indicate the specific research subprojects that would use the resources of the Core unit.

Keep in mind that a Core unit is not designed for conducting research but rather for providing services for the research subprojects. Each shared resource Core must have a single designated Core Director. 3.

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

for details. Submission, Review and Anticipated Start Dates of Intent Receipt Date(s): 30 days Receipt Date(s): Standard dates apply, please see http://grants. nih.

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

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

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

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

gov/grants/funding/submissionschedule.

htm Prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed research Name, address, and telephone number of the Principal Investigator Names of other key personnel Participating institutions Number and title of this funding Although 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 Director, Office of Scientific Review National Institute of Biomedical Imaging and 6707 Democracy Boulevard, Suite 920, Room 956, MSC 5469 Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services) must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application.

Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 (U.S. Postal Service Express Bethesda, MD 20817 (for express/courier service; non-USPS deliveries of applications are no longer permitted (see http://grants. nih. gov/grants/guide/notice-files/NOT-OD-03-040.

html ). At the time of submission, two additional copies of the application and all copies of the appendix materials must be sent to: Director, Office of Scientific Review National Institute of Biomedical Imaging and 6707 Democracy Boulevard, Suite 920, Room 956, MSC 5469 Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services) 3. C.

Application Processing Applications must be submitted on or before the application receipt/submission dates described above ( Section IV. 3. A.

) and at http://grants. nih. gov/grants/dates.

htm . applications will be evaluated for completeness by CSR. Incomplete applications accept any application in response to this funding opportunity 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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review. status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.

era. nih. gov/commons/ .

4. Intergovernmental Review subject to intergovernmental are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . 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 renewal award if such costs: 1) are necessary to conduct the project, and 2) 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 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 .) 6. Other Submission Requirements application instructions outlined in the PHS 398 Application Instructions are to be followed, with the following additional requirements: (required for a resubmission or revision application) is limited to 1 Aims is limited to 1 page.

P01 Program Overview section may not exceed 12 pages, each Individual Research Subproject may not exceed 12 pages, and each Shared Research Core may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants. nih.

gov/grants/funding/phs398/phs398. html ).

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps: IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study; from the IC staff that the IC will accept the application for consideration for 3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the applies to all new, renewal, revision, or resubmission applications.

See NOT-OD-02-004 . PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application.

See http://grants. nih. gov/grants/guide/notice-files/NOT-OD-08-031.

html . the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community.

If the final data/resources are not amenable to sharing, this should be explained in Resource Sharing section of the application. See http://grants. nih.

gov/grants/policy/data_sharing/data_sharing_faqs. htm . Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible.

Applicants are encouraged to discuss data-sharing plans with their NIH program contact.