Applicants for Alcohol Research Center (ARC) grants are to make application on form PHS 398 (Revised 11/2007) [http://grants.nih.gov/grants/funding/phs398/phs398.html]. The following are supplemental instructions to be used in addition to the instructions that accompany the application form.
IMPORTANT: PAGE LIMITATIONS IN THE FUNDING OPPORTUNITY ANNOUNCEMENT (FOA) SUPERCEDE WHAT IS ON THE NIAAA WEB SITE AND MUST BE STRICTLY OBSERVED. THERE ARE FOA-SPECIFIC PAGE LIMITATIONS FOR CERTAIN COMPONENTS. PLEASE EXERT CAUTION WHEN READING THE FOA REQUIREMENTS.
(FACE PAGE)
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ITEM 1. |
Title of Project: The title should identify the central theme of alcohol research around which the Center program will be organized.
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ITEM 2. |
Response to Specific RFA or Program Announcement: Check the box marked "yes" and indicate that the application is being submitted in response to the Request for Applications (AA-) with its Title.
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ITEM 3a. |
Name of Program Director/Principal Investigator: Center Director (Principal Investigator) will be responsible for overall planning and coordination of the Center program.
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ITEM 6. |
Dates of Entire Proposed Project Period: The total project period proposed must not exceed 5 years.
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ITEM 7a. |
Direct Costs Requested for First 12-month Period: In determining direct costs, the applicant must keep in mind that the total request for each year, including direct and Facilities and Administrative (F&A) costs, must not exceed $1.8 million per annum for P50 applications and $2.0 million per annum for P60 applications.
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ITEM 7b. |
Total Costs Requested for First 12-month Budget Period. This amount must not exceed $1.8 million or $2.0 million. |
Form Page 1-continued: Additional form for use only if Multiple PD/PIs are proposed.
(FORM PAGE 2)
Description: Give an overall description of the proposed Center's research program and the central theme around which its research is organized. (Do not exceed the space provided.)
Key Personnel Engaged on Project: Provide information as described in the general instructions contained in the application kit in the following order:
1. Principal Investigator (Center Director);
2. Scientific Director (if different from Center Director);
3. Directors of core research and education components; and
4. All other key professionals including consultants and collaborators. Clearly identify their roles in terms of component(s) in which they are involved.
(FORM PAGE 3)
Number all pages consecutively at the bottom right throughout the application, and type the name of the Principal Investigator (Center Director) at the top right of each printed page and each continuation page. Do not type the name of the Component Director at the top of component page. Rather, type Center Director, Component X.
TABLE OF CONTENTS
Form Page Numbers
Face page, Description, Key Personnel, 1-3
Table of Contents
Detailed Budgets for Year 01-Direct Cost Only 4
Number consecutively
Center as a whole
Administrative Core
Each Research Component
Including budgets for
Contractual/Consortium arrangements
Each Core Component
Including budgets for
Contractual/Consortium arrangements
Each Education Component
Including budgets for
Contractual/Consortium arrangements
Pilot Project Component - for pilot project component include an overall budget for the component and a separate budget for each individual pilot project, clearly indicate the year(s) it will be or is planned to be active
Detailed Budgets for Entire Project Period-Direct Costs Only
Center as a Whole
Administrative Core
Research Components
Core Components
Education Components
Pilot Component
Chart Showing Percent Effort for all Key Personnel by Component and Year
Biographical Sketches
Center Director
Scientific Director
All other Key Personnel in Alphabetical order
Other Support for all Key Personnel
Resources and Environment for the Center as a Whole
Research Plans
A. Introductory Overview: (Please refer to the specific FOA for page limitations) The Center as an Integrated Whole:
1. Specific Aims
2. Background and Significance
3. Progress Report/Preliminary Studies
4. Training opportunities
5. Progress Reports for Completed Components
B. Administrative Core (Please refer to the specific FOA for page limitations)
1. Abstract and Key Personnel
2. Table of contents
3. Center organization and operation
4. Center Publications (competing renewal only)
5. Education, Enrichment, and Dissemination Activities
C. Each Research, Core, and Education Component in Turn (Please refer to the specific FOA for page limitations)
Abstract and Key Personnel
Table of Contents
1. Specific Aims
2. Background and Significance
3. Preliminary Studies/Progress Report
4. Component Research Design and Methods
5. Resources and Environment
6. Inclusion Enrollment Report (Renewal only)
7. Bibliography and References Cited/Progress Report Publication List
8. Protection of Human Subjects
9. Inclusion of Women and Minorities
10. Targeted/Planned Enrollment Table
11. Inclusion of Children
12. Vertebrate Animals
13. Select Agent Research
14. Multiple PD/PI Leadership Plan
15. Consortium/Contractual Arrangements
16. Letters of Support (e.g., Consultants/Collaborators)
17. Resource Sharing Plan (s)
18. If relevant, a brief description of independently funded projects using core component
D. Pilot Project Component (Please refer to the specific FOA for page limitations)
1. Progress Report for completed projects (Renewal application only)
2. Management of pilot program
3. Individual Pilot Project Research Descriptions (Please refer to the specific FOA for page limitations)
E. Appendices (on CD Format)
1. Summary list of the Appendices
2. Separate folder for each component
(FORM PAGE 4)
Detailed Budget for First 12-month Budget Period - Direct Costs Only
Individual budget pages should be submitted for (a) the overall Center budget, (b) each research components, (c) each core components; (d) education component, and (e) the pilot component. The budget for the entire Center for the first project year will retain the imprinted number 4. All subsequent pages will be renumbered consecutively at the bottom right. At the top left of each budget page, indicate clearly the nature of the content, e.g., Administrative Core, Research Component 1 etc.
Overall Summary of Center Budget: This is a budget summary total for the Center. For each budget category (Personnel, Consultant Costs, Equipment, etc.), enter a single amount which is the total for that category of all core components and all research components for year 01. Specific budget details should not be itemized here but should be shown in the separate budget pages for each core and each research component.
Administrative Core Activities: Funds may be requested for personnel responsible for overall direction and support for the Center (such as the Scientific Director and any administrative staff); and for equipment, supplies, and other items to be used by several investigators or available to all Center personnel. Support also may be requested for program enrichment activities (such as colloquia or visiting scientists) and for consultant costs relating to planning and evaluation of the Center program. Administrative support requirements vary widely, and will depend upon the nature of the Center's research and the collective needs of the investigators for resources.
Research, Core, and Education Components: Each individual research and education component and each core component, including pilot projects, if any, should have its own separate budget request. The individual component director and staff should be identified under "Personnel," and all costs related to the activity to be conducted within the component should be included. Budgets for Contractual/Consortium arrangements should be included. Sufficient detail and justification should be given to allow an assessment of the budget request in light of the research, education or service/support being proposed within the component.
(FORM PAGE 5)
Budget for Entire Proposed Project Period - Direct Costs Only
Form page 5 (renumbered with the appropriate consecutive number), is to be used for presentations of budgets for the entire project period and for detailed budget justifications, beginning with a summary of the request for the Center as a whole, then separately for each Center component. At the top left of each budget page, indicate the nature of the content e.g., Administrative Core, Research Component 1, etc.
Overall Summary of the Center Budget
Administrative Core Activities
Research, Core, and Education Components:
Identify and arrange in same order as previous budget section. Some components may not require the full 5-year period of support; therefore, funds should be requested only for the period of time necessary to complete the proposed research. In addition, for example, if a component is to start in the second year of the project period-and funds are requested for a 3-year period, the columns for the 1st Budget Period and the 5th additional year should be left blank. Be sure that the year 01 budget for that component is clearly labeled to indicate the start year. Budget increases in excess of inflationary or cost-of-living increases must be clearly identified and justified.
Chart Showing Percent of Effort for all Key Personnel by Component and Year
Follow the budget presentations with a chart that summarizes for each component the percent of effort to be devoted by each individual listed as key personnel. Present one such chart for each project year, and include a total effort column on each chart. Use continuation pages. If possible, this tabular presentation should not exceed five pages, one for each project year.
(BIOGRAPHICAL SKETCHES)
Self-explanatory
(OTHER SUPPORT for all KEY PERSONNEL)
Self-explanatory
(RESOURCES AND ENVIRONMENT for the CENTER as a WHOLE)
Resources and environment pages may be included for each component if such a presentation will facilitate understanding of the availability of needed resources.
RESEARCH PLANS
A. INTRODUCTORY OVERVIEW - The Center as an Integrated Whole (Please refer to the specific FOA for page limitations)
1. Specific Aims:
Provide an overview of the entire proposed center describing the central theme, purpose, and objectives. Discuss the philosophy and general plans for the proposed grant period and how the Center will achieve its major objectives. The narrative should clearly articulate the reasons a Center approach is needed for this work.
2. Background and Significance:
Describe history of proposed Center; discuss unique contributions that will accrue; potential contribution of each component (including pilot project component if applicable). The significance of the overall research goals and research theme; the importance and relevance of these to the goals and mission of the Center's Program.
3. Progress Report/Preliminary Studies:
The introductory overview of renewal applications should provide a summary of major research accomplishments and progress toward achievement of goals since the last competitive application. Note that detailed progress reports for components continued into the present application should be included in relevant components. Progress reports for completed components should be placed in item 5 below.
4. Training Opportunities:
Provide a brief description of opportunities for research training for persons from various disciplines and professions.
5. Progress Reports for Completed Components (Please refer to the specific FOA for page limitations)
Progress report for each completed component should be place here. Begin with a Form page 2 that includes an abstract (including the specific years the component will function), and a listing of key personnel for that component. Each core component and research and education component should be presented individually. A table of contents (form page 3) should also be included for each component. The table of contents should include a list of appendix materials submitted in support of each component.
B. Administrative Core
1. Abstract and Key Personnel (Form Page 2 renumbered consecutively)
2. Table of Contents
3. Center Organization and Operation
The administrative core component should include discussion of such issues as the framework and organization (including an organizational chart); authority and role of Center Director; authority and role of Scientific Director, committee structure and function; quality control mechanisms; institutional support; decision-making processes and day-to-day management; services provided by the core and how they are administered.
4. Center Publications (competing renewals only)
Center publications may be listed in administrative core. It would be preferable that Center publications relevant to a particular component be listed in the research plan of that component.
5. Educational, Enrichment and Dissemination Activities
Describe any scientific enrichment activities such as special lectures, visiting scientist symposia, seminars, workshops, etc., and any scientific education and research dissemination activities for the public.
C. Research, Core, and Education Components
Research Component Narratives: The narrative for each proposed research component should have a clear description of major objectives and goals, its integration with the other components, and its relationship to the overall Center. Each component narrative should include a subsection on Integration with and Contribution to Center Goals. This information should not be integrated throughout the narrative. In addition, detailed information should be provided in the following areas:
1. Specific aims and objectives
2. Background and Significance including Integration with and Contribution to Center Goals
3. Progress Reports/Preliminary Studies
a. Preliminary studies and findings
b. Progress report if component is proposed in renewal or supplemental application. Report should cover current and past grant period.
4. Research Design and Methods
a. Outline experimental design and procedures.
b. Provide timetable or sequence for proposed studies.
5. Resources and Environment
(For 6-17, please see PHS instructions available at http://grants.nih.gov/grants/funding/phs398/phs398.html)
6. Inclusion Enrollment Report (Renewal only)
7. Bibliography and References Cited/Progress Report Publication List
8. Protection of Human Subjects
9. Inclusion of Women and Minorities
10. Targeted/Planned Enrollment Table
11. Inclusion of Children
12. Vertebrate Animals
13. Select Agent Research
14. Multiple PD/PI Leadership Plan
15. Consortium/Contractual Arrangements
16. Letters of Support (e.g., Consultants/Collaborators)
17. Resource Sharing Plan (s)
18. If relevant, a brief description of independently funded projects using core component
Core Component Narratives: Each core component narrative should include a discussion of contributions that would be made to the Center as a whole. For core components, the research and education components and other research projects to be served should be made clear. The narrative should include how the core will contribute to the overall goals of the Center and how existing research projects or proposed components will benefit from utilizing the core.
The description should clearly indicate the facilities, resources, services, and professional skills that the core will provide. Include information on:
Abstract and Key Personnel
Table of Contents
1. Specific aims and objectives
2. Background and significance
Administration and overall management of the core including:
a. General guidelines for use of services by investigators supported by the Center and/or by independent investigators supported by NIAAA.
b. Plans for use of core by investigators who are not part of the Center.
c. Resources and environment.
3. Progress report/preliminary studies
a. Provide information on past and/or current utilization for renewal applications including benefits accrued in terms of research productivity of core users, cost savings to Center and/or individual investigators.
b. Justify need for continuing core or expanding current capacity, if applicable.
4. Core Component Design and Methods
a. Outline design and procedures of service, techniques, training, etc., to be provided.
b. Identify professional staff and support staff, qualifications, and roles.
c. Describe services/support to be provided and their bearing on research productivity and quality.
d. Identify independent research projects and/or Center-supported research components proposed for core usage.
e. Describe plans for quality control.
5. Resources and Environment
6-17. If applicable, provide information specified on items #6-17 listed for Research Components
18. If relevant, brief descriptions of independently funded research and/or education projects using the core component.
Education Component Narratives: The narrative for each proposed education component should have a clear description of major objectives and goals, its relationship to the other components and to the overall Center. Each component narrative should include a subsection on Integration with and Contribution to Center Goals, In addition detailed information should be provided in the following areas:
1. Specific aims and objectives
2. Background and Significance including Integration with and Contribution to Center Goals
3. Rationale for organization of component
a. Scientific knowledge base and research area for proposed projects
b. Staffing plans for developing and implementing activities
c. Provide time table or sequence of proposed activities
4. Education Approach and Methods
a. Outline project design, procedures and strategies
b. Identify audience or participants and define special populations
c. Identify potential problems on sensitive issues and describe precautions to exercise
d. If applicable, address NIH Guidelines or Inclusion of Women and Minorities in Research Involving Human Subjects.
e. If applicable, address "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human Subjects.
Additional information is also required for the following areas for core, research and education components.
5. Resources and Environment
If applicable, provide information specified on items #6-17 listed for Research Components.
Continue with as many research components as Center application, not to exceed a total of 10 core and research components combined.
D. Pilot Project Component (Please refer to the specific FOA for page limitations)
For each of the first 2 years that pilot project funds are requested, the application must describe the projects to be supported. For projects in years 03-05 the number planned for each year and a brief description of the anticipated studies must be included. Plans for support and management of pilot projects should be described in sufficient detail to permit scientific and technical merit review. Include a description of how progress of funded pilot studies will be evaluated. In addition, there should be a discussion of the process to evaluate and select new/replacement pilot projects.
1. Progress Report for completed projects (Renewal application only)
2. Management of Pilot Program
Include a table showing individual pilot projects and the year(s) they will function.
Renewal applications requesting continuation of pilot project support should provide a progress report on how the pilot program has contributed to the Center's overall accomplishments, and provide an assessment of the benefits derived from availability of pilot project resources.
3. Individual pilot project research descriptions in years 01 and 02 should be concise and adhere to the page limitations indicated in the FOA. Information should include:
a. Abstract and Key Personnel;
b. Specific aims;
c. Background and significance;
d. Methods and procedures;
e. If applicable, provide information specified on items #5-17 listed for Research Components
f. Budget estimate page.
APPENDIX.
All paper PHS 398 applications must provide Appendix materials on Compact Disk (CD) format (See: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html). Consistent with NOT-OD-08-031, the maximum number of reprints that will be accepted for each research component is three and the types of documents acceptable are strictly limited. Publications that are publicly accessible must not be included in the appendix. Each CD should contain a summary listing of the Appendix items included as its first file. There should be a separate folder for each component and if an item is needed for more than one component, a copy of that item should appear in each of the component folders. Also, provide a list of appendix materials as part of the table of contents for each applicable component. The CD should be labeled with the PD/PI name and application title.
Revised: July 2009