Advice on Preparation of a CFAR Application

The purpose of this Advice document is:

1. To suggest an organizational structure that will help reviewers evaluate your application and
2. To help you identify and address all the issues and requirements described in the program announcement.

Although the suggested format is not required, it will substantially aid the review process. The Advice document does not alter or replace information or instructions in the CFAR program announcement.

General Considerations and Organization

• Submit the CFAR application using a PHS-398 application kit. General instructions for the PHS 398 form can be found on http://grants.nih.gov/grants/oer.htm under applications and forms section.
• Please include the information in the order suggested in the "Table of Contents" below.
• The page limitation is 350 pages (maximum) for the entire CFAR or D-CFAR application, excluding appendices, literature cited, required tables (http://www3.niaid.nih.gov/research/cfar/), and Bio-sketches. DO NOT provide other support at this time. Please note the appendices are provided only to the reviewers assigned to the application, and not to all reviewers. Appendices should not contain information required for review by other committee members.
• Applicants submitting a revised application may include an additional 30 pages to respond to the reviewers' comments. These responses should be placed at the beginning of the research plan, with references to locations in the application where changes can be found.

Suggested Table of Contents

The following table of contents outlines all of the elements you will want to include in your application and the suggested organization. Please read the entire Advice document before preparing the application. Some of the terms used in this abbreviated format have a specific meaning that is explained in detail in subsequent pages or in the program announcement.

Initial Section of Application

Face page.
Use the standard PHS 398 face page. Items 1-15: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively. The applicant institution listed on the face page must be the official, fiscally responsible institution of which the CFAR is a part. Multi-institution CFARs must select a single applicant institution as recipient of the CFAR award.

In line 2, please indicate with the title whether this is a D-CFAR or CFAR application.

Description, Performance Sites, and Key Personnel (PHS 398 Form page 2)
The DESCRIPTION is intended to provide a brief summary of the CFAR application. You may want the description to include the long term goals and first year milestones showing areas of scientific emphasis, a description of cores and activities selected, and how you plan to allocate funds to developmental, basic and clinical cores that you have chosen.

Under PERFORMANCE SITES list all cores and locations if different than applicant institution.

Under KEY PERSONNEL, list CFAR Director(s), followed by the Core Directors, Scientific Program Directors, and senior Administrators.

Table of Contents
Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for the CFAR application (see suggested table of contents at the beginning of this document).

The CFAR application should be assembled and paginated as one complete application beginning with the face page and numbering pages consecutively (without using suffixes, e.g., 3a, 3b, etc.), including letters, Literature Cited and Checklists. For Appendices, label and number each separately (e.g., A, B, etc. and page A1, A2, B1, B2, etc. Bearing in mind that the application will be scientifically reviewed core by core, prepare a detailed table of contents that will enable reviewers to locate specific information pertinent to the overall application as well as to each core. A page reference should be included for the budget for each core. Further, each core should be identified by letter (e.g. core A), title, and responsible core leader.

Detailed Budget for Initial Budget Period (PHS-398 Form page 4)
Present a composite budget for the first year for all core support requested. If there are core components or other activities, which are proposed as subcontracts or consortia, with different indirect cost rates, include the total cost in "contractual costs" on the appropriate budget pages, and specify the rate in the Budget Justification. Submit separate budget pages for all consortia/subcontracts.

Budget for Entire CFAR Proposed Period of Support (PHS-398 Form page 5)
Present a composite budget for all years of support requested.

Detailed Budgets for Cores (PHS-398 Form pages 4 and 5)
This is a duplicate of the core budgets listed for each core.

Consortium/Contractual Arrangements for Multi-institutional CFARs and Off-Site Cores
Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). If consortium/contractual activities represent a significant portion of the overall project, explain why the applicant organization, rather than the ultimate performer of the activities, should be the grantee.

Biographical Sketches (PHS-398, Biographical Sketch Format Page)
Please arrange in the following order:

• PI (usually the CFAR Director)
• Co-director(s) (if applicable)
• Scientific Program Directors
• Core directors, senior CFAR administrators, senior level CFAR scientific staff (in alphabetical order by last name)

A standardized format for the Biographical Sketch (maximum of four pages for each key person) must be used for the CFAR grant application. A format page, including a sample biographical sketch, has been developed and is available on the NIH website (http://grants.nih.gov/grants/funding/phs398/biosketchsample.pdf).

Eligibility and Investigator Participation (see program announcement)
NIH will provide applicants with a NIH AIDS -Funded Research Base (FRB) Excel spreadsheet indicating all investigators receiving NIH AIDS funding at an applicant's institution or institutions if a multi-institution application), arranged by NIH Institute. You should request the spreadsheet from Ms. Angela Ballard at ballarda@niaid.nih.gov. Applicants are requested to indicate those investigators who have formally agreed to participate in the CFAR by indicating the type of participation. Applicants should provide a brief explanation at the bottom of the table as to why investigators may not be participating. If there will be participation in the CFAR by investigators who are not listed on the spreadsheet provided applicants are encouraged to list them on a separate spreadsheet using the same format.

Investigators planning to participate in the CFAR should provide the CFAR PI with written confirmation that they intend to participate in the CFAR should it be funded. These documents should not be sent with the application but may be requested by the review committee or at the time of award.

Resources Format Page
Do not complete for the overall application. Essential information is to be presented in the individual core sections of the application.

RESEARCH PLAN

Overall description of the proposed CFAR

• Describe the CFAR organizational structure in the parent institution and collaborating institutions.
• Provide an organizational chart for all CFAR components, CFAR director(s), and core directors.
• Describe the major locations of CFAR activities including those in collaborating institutions and discuss distances between locations. You may also wish to provide a chart or map illustrating the location and setting of the CFAR in relation to the parent and collaborating institutions, especially if sites are significantly separate, and to describe the functional relationships.
• Succinct summary of HIV/AIDS science at the institution(s) that justifies the need for CFAR support. Include Table 4 http://www.niaid.nih.gov/research/cfar/cfarpa.htm.

Administrative Core -Part I (this will be part of the Terms and Conditions of Award)

The following bullet points should be addressed in this section: (See CFAR program announcement Section IV. for detailed information of each section.)

The strategic plan

1. Strengths
2. Opportunities
3. Action plan
4. Outcome measurements

2. CFAR policies and procedures
1. Proposed roles in decision making processes
2. Reporting Processes
3. Annual strategic planning processes
4. Needs assessment and selection process for scientific programs, basic / clinical cores, and assigning priorities to potential cores and scientific programs
5. Advisory committees
   Describe membership of all committees, how participants were selected, terms of appointment, authority and responsibility of members.
3. Administrative Issues
1. The protection of human subjects.
2. Inclusion of women, children, and minorities.
3. All clinical studies supported by CFAR comply with OHRP / NIH.
4. If human subjects are used, it should be indicated on the face page.

Description of Individual Cores
The purpose of this section describing individual cores is to identify the 'nuts and bolts' of how the various cores of the CFAR will be organized and specifically how they will accomplish the action plan described under the strategic plan section. It will also provide an objective assessment of the effectiveness of the strategic plan and policies and procedures.

The following information should be provided for all cores. Please begin with the administrative core - part II, followed by the developmental core, and the clinical and basic cores. Additional information needed for administrative and developmental cores and additional activities is below.

• Core Description (PHS-398 Form page 2)

  List a letter designation for the core. (Please use "A" for the administrative core, "B" for the developmental core and begin with "C" for the basic and clinical cores.). If cores are eliminated and replaced by other cores do not use the letter previously assigned to the omitted core. Also include the core name, core director, and all staff involved in the management and maintenance of the core with their function. For the basic and clinical cores include a description of the purpose of the core, how it will provide added value to the ongoing AIDS research, and a brief description of key scientific projects supported. If applicable, cite grant numbers and NIH Institute-specific programs supported by the core, and be specific about how each core provides or will provide support. Include Tables 1, 2, and 5 from http://www.niaid.nih.gov/research/cfar/cfarpa.htm.

• Budgets for each core (PHS-398 Form pages 4 and 5)

  Provide the budget for the first year of each core and a budget for all years of support requested for each core. For cores that will be supported in part or entirely by sources other than this grant: use the budget page to show the amount requested in the CFAR application and also show the total amount from other sources, in parentheses, under the total requested in the application.

• Justification of budget requests

  Provide justification for budget requests with the appropriate core facility budget. Do not include the justifications with the budgets in the front of the application. Provide necessary information documenting the level of effort on CFAR activities. The percent effort requested should be limited to time devoted specifically to managing CFAR. The effort devoted to CFAR activities should not be that which would normally be supported by research grants. Please see the CFAR program announcement.

• Resources and environment form (PHS-398, Resources Format Page)

  Using this form, indicate the facilities at the applicant institution, which will be available to CFAR investigators. In addition, some applicants may have a core at a site outside of the applicant institution and if so, an additional Resources and Environment Form must be used to identify facilities available to the CFAR investigators who will use that core. At the top of the form, following the instructions, clearly indicate the name of the Department, Division or Institute, which is also identified in Item 9 of the face page of the application (page 1, PHS-398).

• Research plan

  Describe: Progress (if this is a recompeting application), aims, and planned activities of the core with sufficient detail for evaluation by the review committee.

• Policies and procedures for individual cores

1. Reallocation of funds. Describe the process for reallocating funds within the core as research needs change, as well as plans for managing resources to permit core facility equipment maintenance. Current CFARs use a charge back mechanism to R01 grants of core users within most basic and clinical cores to partially offset these needs. Other methods, alone or in combination with this strategy, can be used but must be explained in sufficient detail.
2. Allocation of space within each core.
3. Percent effort of core directors.
4. Selection of personnel within each core.
5. Objective evaluation criteria/outcome measurement for all cores.
6. Selection and training. For basic and clinical cores describe the process for selection of users, and training, if necessary.
7. For developmental core: describe the process for selection of developmental projects to support (e.g., a peer review process).
8. For developmental core: describe the outcome evaluation of developmental projects
• Policies and procedures for scientific programs
1. Identification of programs and scientific directors
2. Program management, and identification of participants
3. Criteria for identifying when a program needs to be terminated
4. Identification of projects defined by a program, and mechanisms for funding
5. Objective evaluation criteria/outcome measurement for all programs
• Core Users

  For basic and clinical cores only, list proposed users and usage in percent of time expected for each major core user using Table 5 located on http://www.niaid.nih.gov/research/cfar/cfarpa.htm with each specific core. For current CFARs include the current core users and actual percent time use by each major user. Describe the projects supported (one paragraph). Cite grant numbers listed in the excel table showing the NIH AIDS funded research base of the institution(s). Cite Institute-specific programs supported by the core, and be specific about how each core provides or will provide support.

• Human subjects (see PHS-398 application kit)
• Vertebrate animals (see PHS-398 application kit)
• Core Literature

  Provide a list of all literature cited describing studies supported by the core (for renewal applications).

Developmental Core
In addition to the information above, describe the following:

For Existing CFARs:

1. Describe outcome measurements for previous recipients of developmental funding. Please use Table 3 from http://www.niaid.nih.gov/research/cfar/cfarpa.htm.
2. Provide animal and human subjects information and gender and minority information for pilot projects funded through the developmental core.

First year plan for all applicants:

1. Provide a list of potential applicants or recipients, project title and a brief description of the work to be done for each for the first year of developmental core funding.
2. If applicable describe projects developed by Scientific Programs to be funded for the first year of CFAR support. Include Project Director, other participating investigators, relevant research environment, budget, and research plan per the PHS398 form.
3. Provide animal and human subjects information and gender and minority information for pilot projects, and projects developed through the Scientific Programs to be funded through the developmental core.

Additional CFAR Supported Activities
These activities must be assigned to a core. For example, support for minority investigators could be through funds allocated for a pilot project funded through the developmental core or a core could be developed for international collaborations. For each additional activity selected indicate the leader of the project, describe the purpose, first year plan, outcome measurements planned and criteria used to modify funding for subsequent years.

Examples

International collaborations including support for foreign investigators Development of minority scientists in AIDS research
CFAR/CFAR collaborations
Outreach
AIDS research communication
Industry collaborations
Any other activities

Institutional Commitment (see program announcement)

• Provide a letter(s) from the appropriate institutional official(s) (e.g., Dean, President, or Provost) defining:
• Position, authority, and reporting responsibility (on institution's organizational chart) for the CFAR director.
• Financial and other resource support for the CFAR that will be provided by the applicant institution(s).
• Authority or influence that the CFAR director has over other AIDS projects, facilities and space, as well as decision-making authority for hiring/approving new faculty and support personnel.

Scientific Programs
Describe any scientific programs that will be part of the CFAR. Include procedures for selection, Scientific Program Directors, members, procedures to encourage collaboration and to identify scientific projects. Also describe procedures for review and funding of any projects through the developmental core and procedures for continuation, termination, and rebudgeting funds for projects, and identification of new project leaders if that need should arise. Specific projects to be funded in year 1 should be described under the developmental core.

LITERATURE CITED

Provide a composite list of references.

The CFAR application should be assembled and paginated as one complete application beginning with the face page and numbering pages consecutively (without using suffixes, e.g., 3a, 3b, etc.), including letters, Literature Cited and Checklists. For Appendices, label and number each separately (e.g., A, B, etc. and page A1, A2, B1, B2, etc.

APPENDICES

Appendices are provided only to reviewers assigned to the application, and not to all reviewers. Appendices should not contain information required for review by other committee members.

For Appendices, label and number each separately (e.g., A, B, etc. and page A1, A2, B1, B2, etc.

CHECKLIST

(format page)

Complete for the entire application and place at the end of the application package.

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Last Updated 02.21.06 (alt)