The National Institute of Neurological Disorders and Stroke (NINDS) uses the program project (P01) and specialized center (P50) grant mechanisms to encourage multidisciplinary research approaches to a diverse array of nervous system disorders. These grant mechanisms are designed to support broadly based multidisciplinary research programs that have a well-defined central research focus or theme. The P01 and P50 grant mechanisms support a minimum of three interrelated projects that contribute to the program objective. The grants may also include support for common or shared resources (Cores) required for the conduct of two or more of the component research projects. Interrelationships among component projects are expected to result in a greater contribution to the program goals than if each project were pursued separately.
For the purposes of preparation of an application or the subsequent review, Program Projects (P01s) and Specialized Centers (P50s) are indistinguishable and will hereafter be collectively referred to as Program Project Grants (PPGs). The chief distinction between NINDS P01 and P50 grants is that new P50 applications are accepted only in response to a Request for Applications (RFA) or Program Announcement (PA) soliciting applications in a particular area of research.
There is a ten year limit on awards for all P01s and remaining unsolicited P50s.
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NIH policy requires that applicants for ALL unsolicited grants that request $500,000 or more in direct costs (exclusive of consortium F&A costs) for ANY year, must obtain agreement from NINDS program staff that NINDS will accept the application for consideration for an award. This policy applies to new, amended, and competing continuation applications.
To ensure compliance with this policy, the applicant must: 1) contact the NINDS program staff at least 6 weeks before submitting the application; 2) obtain agreement from the NINDS staff that NINDS will accept the application for consideration for award; and 3) include a cover letter with the application identifying the NINDS staff member who agreed to accept assignment of the application. Additional information on this policy is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. Any application subject to the policy that does not contain the required information in the cover letter may be returned to the applicant without review.
It is also NIH policy that foreign institutions and international organizations are not eligible to receive program project and center grants.
In addition to the NIH policies stated above, it is the policy of NINDS that unsolicited Program Project and Research Center grants may not exceed $1,000,000 direct costs (exclusive of consortium F&A costs) in ANY year. All P01s and currently funded, unsolicited P50s have an award limit of ten years.
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Program project and research center grants support investigator-initiated research programs in which a team of investigators works in a clearly defined area of mutual scientific interest. In a program project, achievement of the objective of the research effort is facilitated by the sharing of ideas, data, and specialized core resources such as equipment, laboratories, clinical facilities, and administrative services. An essential requirement is a central theme toward which the total scientific effort is directed and to which each research project relates. In keeping with the tradition of investigator-initiated research, the NINDS expects the program director to define the integrating theme and to develop the approaches that would be used to accomplish the objective of the proposed research program. The theme of a program project may be, for example, basic research on regeneration and plasticity in the nervous system or basic and clinical research on a specific disease process; the unifying concept may be an hypothesis concerning the fundamental mechanisms that result in the clinical manifestations of the specific disease process.
The projects to be included in a PPG should be carefully considered. All projects that are included will affect the overall outcome of the review and should be of the highest technical merit.
The program director must be an established leader in scientific research with demonstrated capabilities in program direction. Regular meetings of participating investigators, who share and evaluate results and new ideas, are essential to the consolidation of the research projects into a cohesive program. In addition, an internal advisory committee can be effective in assisting the program director in making scientific and administrative decisions. An annual review of the program by external consultants who meet as an external advisory committee is strongly recommended.
In summary, the following distinguishing features must be well documented in the program project and research center application.
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The following guidelines are offered to supplement the instructions for grant application form PHS 398 (revised 04/2006). Instructions for obtaining application materials and directions may be found at http://grants.nih.gov/grants/forms.htm.
Since the Form PHS 398 is designed primarily for the traditional research project grant (R01) application, several sections have to be modified and expanded so that the form can be used to provide the information needed for a program project grant application.
Applications must adhere to the page limitations outlined in the PHS 398 form instructions, or they will be returned to the applicant without review. The 25-page limitation for the Research Plan applies to each individual project and core of a program project or center application. Graphs, charts, figures and tables that are essential to the research plan must be included within the 25 pages. A request for a waiver of the page limits should be directed to the Chief, Scientific Review Branch, NINDS. An application that does not observe these limitations may be returned. The appendix will not be duplicated with the application; the five sets that you provide will be sent only to certain members of the SRG who will serve as the primary reviewers of the application. Appendix material should be sent separately (See Appendix ).
Part I of the PHS 398 Instructions Files contains specific instructions for entering information in the grant application form. Applicants should follow these instructions carefully and give special attention to the issues outlined below, as they must be adequately documented on the appropriate forms in the application. Please note that several significant changes were announced in April 2006. See the following link for details: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-056.html.
Any application requesting $500,000 or more direct costs for any year must include a covering letter that identifies the NINDS program staff member who agreed to accept the application. Any application that does not contain the required information will be returned.
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Applicants should prepare only a single face page for the entire application, not one for each component. For P50 applications responding to an RFA or PA, the applicant should check "Yes" on line 2 of the face page, followed by the relevant RFA or PA number and title. The title should be followed by "(P50)". For P01 applications responding to an RFA or PA the applicant should check "Yes" on line 2, followed by the RFA or PA number and title. The title should be followed by "(P01)". For unsolicited applications, the applicant should check "No" on line 2. Complete all items on the face page of the application. This is page 1 of the application; number all succeeding pages consecutively. Do not use letters or Roman numerals for pagination.
In the table provided, list the program director for the overall program project and the principal investigator of each component project or core. List the investigators in the same order in which their individual projects are presented. Under "Role on Project" state the investigator's role on the PPG (e.g., "Principal Investigator, Project 1", "Co-PI, Core B", or "Consultant, Project 3").
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Prepare a detailed table of contents that will enable reviewers to find specific information readily. Present the projects first and the core units last. Refer to Illustration 1 for a typical format and as a guide to the organization of the components of the application. Identify each project by title, and assign each project a number and each core unit a capital letter that reflects the order in which the projects and core units are presented in the application, and provide the name of the investigator responsible for each component. Number the pages consecutively. Indicate the beginning page numbers for each project and core unit.
For the entire PPG, as well as for each project and core, prepare the standard "Detailed Budget for Initial Budget Period" and the "Budget for Entire Proposed Project Period." (Illustrations 2 and 3). Identify each budget page (e.g., "Composite", "Project 1", etc.). Place the composite budget pages first, followed by the projects and cores. All budgets (composite, projects, and cores) will be in this one section. Individual project budgets should not be included with the project research plans.
NOTE: The NINDS does not accept applications for program project and research center grants that request more than $1,000,000 (direct costs) in any year. Facilities and administration costs incurred by subcontract/consortium arrangements, while reflected in the total direct cost for the entire application, do not count for purposes of the NINDS $1,000,000 cap. Facilities and administration costs associated with subcontract/consortium arrangements should be explicitly identified in the appropriate sections of the form pages.
Person Months Distribution among Projects
If appropriate, insert a Person Months Distribution table following the Budget section (See Illustration 4.)
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Prepare biographical sketches as described in the Instructions for Form PHS 398. Put the biographical sketch for the Program Director of the PPG first, followed by the other biographical sketches in alphabetical order. Put all of the biographical sketches together in one section immediately after the budget section. Biographical sketches are required for all key personnel and consultants who participate in the research projects and core units.
If necessary, use continuation pages to describe multiple facilities and to explain geographic relationships. Present all Resources pages in one section.
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When submitting a revised or amended application, summarize in an Introduction to Revised Application any substantial additions, deletions, and changes that have been made. Include responses to criticisms in the previous summary statement and highlight these changes in the text by appropriate bracketing, indenting, or changing of typeface. Incorporate in the progress report any work that has been completed subsequent to the prior version. A revised application will be returned without review if substantial revisions are not clearly apparent. The Introduction to Revised Application section should not exceed three pages unless a waiver has been obtained from the Chief of the Scientific Review Branch, NINDS.
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Prepare an introductory statement that describes the rationale, scientific goals, and significance to the field of the program project. Indicate all prior and current collaborative arrangements, describing briefly other projects not included in the application that would contribute to the intellectual environment. Explain the strategy for achieving the objectives of the overall program and how each project and core unit relates to that strategy. The general introduction is the appropriate place to:
There are no page limits for this section. However, a limit of 3-5 pages is recommended.
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Describe the lines of authority and responsibility for decision-making and administration, beginning with the program director and including the principal investigators responsible for the research projects and core units. Indicate where, in the chain of responsibility, internal or external advisory committees would be used, and describe their function. In new applications describe the expertise to be represented in the external advisory committee, but do not name potential members of the committee and do not include letters from such individuals. Members of the internal advisory committee should be named and their letters of agreement included.
There are no page limits for this section. However, every effort should be made to be succinct.
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Competing continuation (renewal) applications must include a progress report that highlights achievements of the overall program project since the last competitive review. (A specific progress report is required for each project in its respective section of the application.) The progress report must include the following information:
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The Research Plan of each research project or core should consist of a title page, Description (use form page 2 of form PHS 398 for this), and sections on Specific Aims, Background and Significance, Preliminary Studies/Progress Report, Research Design and Methods, Human Subjects Research (if appropriate), Vertebrate Animals (if appropriate), Literature Cited, Consortium/Contractual Arrangements (as appropriate), Resource Sharing, and Letters of Support (Consultants), as described in the PHS 398 instructions. The Specific Aims, Background and Significance, Preliminary Studies/Progress Report, and Research Design and Methods sections, taken together, should not exceed 25 pages.
Receipt dates are the same for all Program Project and Research Center grant applications, including renewal and revised applications. The receipt dates can be found on this website: http://grants.nih.gov/grants/funding/submissionschedule.htm .
Investigator-initiated AIDS applications have the following receipt dates: January 7, May 7, and September 7. All AIDS applications receive an expedited review.
The original and five copies of the completed application must be mailed to the NIH Center for Scientific Review (CSR), the address label for which is included in the application kit (Form PHS 398). The CSR is responsible for assigning all program project applications to the appropriate Institute of the National Institutes of Health. The assignment to an Institute is based on the central theme and goals of the proposed program. PPG applications assigned to the NINDS are given a study section assignment by the Chief of the NINDS Scientific Review Branch.
If it does not place an undue burden upon the institution, applicants are asked to send at the time of submission an additional copy to the Chief, Scientific Review Branch, NINDS, NSC Building, Room 3208, 6001 Executive Blvd., MSC-9175, Rockville, Maryland 20852 (for courier delivery). Submission of this copy will allow more time for the scientific review administrator to study the application and plan for its review.
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Applicants should wait to submit any Appendix materials until they have been notified of the assignment (including Institute,
study section, and application number). This information will appear in their NIH Commons account. Once the application has
been assigned to NINDS and has received a study section assignment, appendix materials should be sent on 5 CDs to:
Chief
Scientific Review Branch, NINDS,
NSC Building, Room 3208
6001 Executive Blvd., MSC-9529
Rockville, Maryland 20852
Details on the latest rules about what may be included in an appendix can be found in the following NIH Guide notice: http://grants1.nih.gov/grants/guide/notice-files/not-od-08-031.html
Please pay close attention to the rather stringent limits on a) what may be included as an appendix item and b) the total number of appendix items that are allowed.
It is very helpful if the appendix materials are separated by projects and cores. Also, reviewers find it very helpful if there is a one or two sentence explanation of how each item in the appendix is intended to help them evaluate the application.
Applicants should consult the Scientific Review Officer assigned to the application regarding the format and deadline for submission of any additional supplementary material.
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The first phase of the review involves evaluating the individual research projects and cores. Projects are evaluated using the standard NIH review criteria for research projects (Significance, Innovation, Approach, Investigators, and Environment). Cores are evaluated, and approved or disapproved, using the following review criteria:
The second phase of the review by the SRG assesses the overall program using the following review criteria:
All of the strengths and weaknesses identified during both phases of the SRG's review enter into the overall score assigned to the application.
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The second level of the peer review system is the review by the National Advisory Neurological Disorders and Stroke Council. Items considered in this review include the:
Inquiries about whom to contact regarding acceptance of applications over $500,000 direct costs/year, application format, and review procedures may be addressed to:
Chief, Scientific Review Branch,
Division of Extramural Research, NINDS, NIH
NSC Building, Room 3208, MSC 9529
6001 Executive Blvd.
Bethesda, Maryland 20852
(301) 496-9223
FAX: (301) 402-0182
Inquiries regarding budget and/or grant policy may be addressed to:
Chief, Grants Management Branch
Division of Extramural Research, NINDS, NIH
NSC Building, Room 3290, MSC 9537
6001 Executive Blvd.
Bethesda, Maryland 20852
(301) 496-9231
FAX: (301) 402-0219
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Additional funding for the expansion of ongoing projects or continuation of projects originally recommended for a period shorter than the parent grant, or for new research projects that relate to the central theme of the program, may be requested through a supplemental application. The Program Director identified on the Notice of Grant Award should be contacted early in the planning stage. There are some restrictions on the submission of supplemental applications. For example, proposed expansion in the final year of committed support is not permitted.
No supplemental application will be accepted for review that would cause the parent grant to exceed the NINDS $1,000,000 direct cost limitation for PPGs.
Strong justification must be provided for any program expansion. A persuasive case must be made that supplemental funds would increase the scientific quality of the entire program. Since the last competitively reviewed grant application upon which the supplemental request is developed is available only as a resource document during the technical merit review, the existing program must be described in sufficient detail in the supplemental application to assure adequate evaluation of the requested expansion. The overall format and content of the supplemental application must conform to the instructions provided in the applicable preceding sections of these Guidelines. Reference is made below only to situations in which supplemental applications may require additional information to that specified in the preceding instructions.
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Line 1 must be the exact title of the parent grant, and line 3 must be the name of the program director of the parent grant. Likewise, the other items on the face page which pertain to the applicant organization should contain the same data as the parent grant. Type "P01 Supplement" or "P50 Supplement", as appropriate, after the word "Title" on line 2 of the face page.
On page 2 of the Application Form PHS 398, provide a brief description of the entire program in addition to a summary of the supplemental request.
For the supplemental funds requested, prepare for each affected project and core the standard "Detailed Budget for Initial Budget Period" and the "Budget for Entire Proposed Project Period." Prepare composite budgets (Illustrations 2 and 3) if more than one research project or core unit is planned. Update the originally submitted "Percentage Effort Distribution Among Projects and Core Units" (Illustration 4), to include the supplementary component(s) requested. Budget periods must conform to the parent grant, and the duration of the supplement cannot extend beyond the parent grant. If the timing of the application is such that only a partial year of supplemental support could be provided in the first supplemental year, prepare a full 12 month budget for the first supplemental year. Grants management staff will prorate the award in accordance with the start date.
When appropriate, provide brief explanations, in tabular form, of any changes in the budgets of the projects and core units since the last competitive review. In particular, note and explain any re-budgeting of funds among projects and core units.
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TABLE OF CONTENTS
SECTION 1 PAGE
Form Page 1 (Face Page) 1
Description (Abstract) and Key Personnel Engaged on Project 2
Table of Contents 3
Composite Budget for First 12 Month Budget Period 4
Composite Budget for All Years of Support Requested 5
Effort Distribution Among Projects and Core Units 6
Individual First and Future Years Budget Estimates
Project 1 7
Project 2 9
Project 3 11
Project 4 13
Project 5 15
Core A 17
Core B 19
Biographical Sketches 21
Resources and Environment 91
SECTION 2
Introduction 100
Project 1 105
Project 2 129
Project 3 154
Project 4 179
Project 5 204
Core A 229
Core B 243
Return to "Illustrations"
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DETAILED BUDGET FOR INITIAL BUDGET PERIOD DIRECT COSTS ONLY |
FROM |
THROUGH |
||||||||
PERSONNEL (Application organization only) |
Months Devoted to |
INST. |
DOLLAR AMOUNT REQUESTED (omit cents) |
|||||||
NAME |
ROLE ON |
Cal. |
Acad. |
Sum. |
SALARY |
FRINGE |
TOTAL |
|||
Project 1 |
|
80,771 |
13,920 |
94,691 |
||||||
Project 2 |
79,954 |
14,586 |
94,540 |
|||||||
Project 3 |
50,679 |
5,204 |
55,883 |
|||||||
Project 4 |
93,331 |
27,999 |
121,330 |
|||||||
Core A |
133,932 |
44,912 |
178,844 |
|||||||
Core B |
57,699 |
17,310 |
75,009 |
|||||||
SUBTOTALS -------------------------------------------------> |
496,366 |
123,931 |
620,297 |
|||||||
CONSULTANT COSTS Core A $3333 |
3,333 |
|||||||||
EQUIPMENT (Itemize) Project 3 $15333Project 4 $12666 Project 4 $28950 |
|
|||||||||
SUPPLIES (Itemize by category) Project 1 $31999Project 2 $38132 Project 3 $34666 Core A $ 1867 Core B $84893 |
220,822 |
|||||||||
TRAVEL Project 1 $ 1333 Project 3 $ 1333 Project 2 $ 1333 Core A $ 2667 |
6,667 |
|||||||||
PATIENT CARE COSTS |
INPATIENT | |||||||||
OUTPATIENT | ||||||||||
ALTERATIONS AND RENOVATIONS (Itemize by category) |
||||||||||
OTHER EXPENSES (Itemize by category) Project 1 $ 6733 Project 2 $ 7800 Project 3 $11066 Project 4 $ 2667 Core A $ 333 Core B $10000 |
38599 |
|||||||||
CONSORTIUM/CONTRACTUAL COSTS |
DIRECT COSTS |
53,332 | ||||||||
SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (item 7a, Face Page) |
$811,936 | |||||||||
CONSORTIUM/CONTRACTUAL COSTS |
DIRECT COSTS |
$17,333 | ||||||||
TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (item 7a, Face Page) | $1,017,332 |
PHS 398 (Rev. 04/06) Page _____ (Form Page 4)
BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT
DIRECT COSTS ONLY
BUDGET |
INITIAL |
ADDITIONAL YEARS OF SUPPORT REQUESTED |
||||
2nd |
3rd |
4th |
5th |
|||
PERSONNEL: Salary and fringe benefits. Applicant organization only. |
620,297 |
620,297 |
620,297 |
620,297 |
620,297 |
|
CONSULTANT |
3,333 |
3,333 |
3,333 |
3,333 |
3,333 |
|
EQUIPMENT |
56,949 |
56,949 |
56,949 |
56,949 |
56,949 |
|
SUPPLIES |
220,822 |
220,822 |
220,822 |
220,822 |
220,822 |
|
TRAVEL |
6,667 |
6,667 |
6,667 |
6,667 |
6,667 |
|
PATIENT CARE COST |
INPATIENT | |||||
OUTPATIENT | ||||||
ALTERATIONS AND RENOVATIONS |
||||||
OTHER EXPENSES |
38,599 |
38,599 |
38,599 |
38,599 |
38,599 |
|
CONSORTIUM CONTRACTUAL COSTS |
DIRECT |
53,332 |
53,332 |
53,332 |
53,332 |
53,332 |
SUBTOTAL DIRECT COSTS |
999,999 |
999,999 |
999,999 |
999,999 |
999,999 |
|
CONSORTIUM CONTRACTUAL COSTS |
F&A |
17,333 |
17,333 |
17,333 |
17,333 |
17,333 |
TOTAL DIRECT COSTS |
1,017,332 |
1,017,332 |
1,017,332 |
1,017,332 |
1,017,332 |
|
TOTAL DIRECT COSTS FOR ENTIRE PROPOSED PROJECT PERIOD (item 8a, Face Page) |
$ 5,086,660 |
JUSTIFICATION. Follow the budget justification instructions exactly. Use continuation pages as needed.
PHS 398 (Rev. 04/06) Page _____ (Form Page 4)
From Budget for Initial Period:
Describe the specific functions of the personnel, collaborators, and consultants and identify individuals with appointments
that are less than full time for a specific period of the year, including VA appointments.
For all Years:
Explain and justify purchase of major equipment, unusual supplies requests, patient care costs, alterations and renovations,
tuition remission, and donor/volunteer costs.
From Budget for Entire Period:
Identify with an asterisk (*) on this page and justify any significant increase or decrease in any category over the initial
budget period. Describe any change in effort of personnel.
For Competing Continuation Applications:
Justify any significant increases or decreases in any category over the current level of support.
Return to "Illustrations"
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Personnel - Position |
Project or Core Designation |
Totals |
||||||
1 |
2 |
3 |
4 |
5 |
A |
B |
||
Doe, J. - Principal Investigator |
1.5 |
3.0 |
1.5 |
6.0 | ||||
Walsh, P. - Co-Investigator |
1.2 |
1.8 |
3.0 | |||||
Smith, M. - Technician |
1.5 |
1.5 |
3.0 | |||||
To Be Named: | ||||||||
Cell-culture technician |
4.0 |
2.0 |
6.0 |
12.0 | ||||
Programmer |
1.5 |
1.5 |
6.0 |
9.0 | ||||
Senior Neurologist |
3.0 |
2.0 |
5.0 | |||||
Patient Coordinator |
1.0 |
1.0 |
Last updated April 21, 2008