Centers for AIDS Research

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 Funding Opportunity Announcement (FOA).

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 FOA.

General Considerations and Organization

• Submit the CFAR application using the PHS 398 application kit. General instructions for the PHS 398 form can be found under instructions and forms section (http://grants1.nih.gov/grants/funding/phs398/phs398.html).
• Please include the information in the order suggested in the "Table of Contents" below.
• The maximum page limit for the entire CFAR or D-CFAR application is 350 pages, excluding appendices, literature cited, required tables, and Bio-sketches. There is no page limit for each Core section.
• Appendices should not contain information required for review by other than the designated reviewers (e.g., literature cited, required tables, bio-sketches). Please note that appendices are provided only to reviewers assigned to a particular application, not to all reviewers.
• Appendix material must be provided on CD only, and five identical CDs should be included in one package with the application. Please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html for more information.
• DO NOT provide Other Support information with the initial application submission.
• Applicants submitting a resubmission may include an Introduction of no more than 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 revisions can be found.

Suggested Table of Contents

The following table of contents outlines all the elements you will need to include in your application and the suggested organization for these elements. 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 either in subsequent pages here or in the FOA.

Initial Section of Application

Face page.
Use the PHS 398 Face Page. Items 1-14: 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.

Project Summary, Performance Sites, and Scientific/Key Personnel (PHS 398 Form pages 2 and 3)
The PROJECT SUMMARY is intended to provide a brief description of the CFAR application. You may want the description to include the long term goals and first year milestones, indicating areas of scientific emphasis, a description of the Cores and activities selected, and how you plan to allocate funds to Developmental, Basic and Clinical Cores that you have chosen.

Under Performance Sites include the institutions that make up the CFAR or D-CFAR (i.e, the location of the CFAR Core facilities).

Under Scientific/Key Personnel, list PI (usually the CFAR Director), 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 Director.

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 that 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, but shown together in a single location. While located here, they are to be provided later in the application as well with each separate 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://grants1.nih.gov/grants/funding/phs398/biosketchsample.pdf.

Eligibility and Investigator Participation (see FOA)
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), listed by NIH Institute.

You should request the spreadsheet from Ms. Chau Nguyen (Contractor, Henry M. Jackson Foundation) at nguyencd@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 are investigators who will participate in the CFAR but are not listed on the spreadsheet provided, a separate spreadsheet can be created using the same format to list these investigators.

Investigators who plan to participate in the funded CFAR should provide the CFAR PI with written confirmation of their intent at the time the application is being prepared. 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 provide this for the overall application. Essential information is to be presented in the individual Core sections of the application.

Research Plan

(See Section I.1 in the CFAR FOA for the research objectives.)

Overall description of the proposed CFAR

• Describe the CFAR organizational structure in the parent institution, and in any 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 parent institution in relation to collaborating institutions, especially if sites are significantly separate, and describe the functional relationships.
• Provide a succinct summary of HIV/AIDS science at the institution(s) that justifies the need for CFAR support.

CFAR and D-CFAR Overview and Administrative Core

The elements listed below should be addressed in this section: (See CFAR FOA Section IV.6 for detailed information of each section.)

Any modification of the following elements resulting from recommendations made by the peer review group during review will be incorporated into the Terms and Conditions of Award at the time of award.

Any revisions to the listed elements made after the Notice of Award will require prior approval from the NIH.

1. Strategic plan
1. Strengths
2. Opportunities
3. Action plan
4. Outcome measurements
2. Policies and procedures
1. Proposed roles in decision-making processes
2. Annual strategic planning processes
3. Needs assessment and selection process for Scientific Programs, Basic and Clinical Cores, and assigning priorities to potential Cores and Scientific Programs
4. Advisory committees - describe membership of all committees, how participants are selected, terms of appointment, authority and responsibility of members.
3. Administrative issues
1. Protection of human subjects
1. All clinical studies supported by CFAR comply with OHRP/NIH
2. If human subjects are used, it should be indicated on the face page.
2. Inclusion of women, children, and minorities
4. CFAR tables
1. Include "Existing Core Facilities at the Institution Applying for a CFAR Award" Table from in the in Introduction/Overview section.
2. The NIH AIDS-funded Research Base (FRB) spreadsheet provided by NIH should be included here.

Description of Individual Cores

The purpose of this section 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 should also serve to provide an objective assessment of the effectiveness of the Strategic Plan and of CFAR Policies and Procedures.

The following information should be provided for all Cores. Please begin with the Administrative Core, followed by the Developmental Core, and the Clinical and Basic Cores. Additional information required for Administrative and Developmental Cores, and additional activities is located below.

• Core Description (PHS 398 Form page 2)

Assign a letter for each Core. (Please use "A" for the Administrative Core, "B" for the Developmental Core and assign "C" for the Basic and Clinical Cores.). For renewal applications, if Cores are eliminated do not assign that Core’s letter to a substituted or new Core. Also include the Core name, Core Director, and all staff involved in the management and maintenance of the Core, and their functions. For the Basic and Clinical Cores provide a description of the Cores purposes, how they will provide added value to the ongoing HIV/AIDS research, and briefly describe the key scientific projects to be 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.

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

Provide the budget for the first year of each Core and the total budget for all years of requested support. For Cores that will be supported in part or entirely by sources other than this grant, under Total Requested, indicate the amount requested in the CFAR application and in parentheses, the total amount coming from other sources.

• Budget request justifications

Provide justification for budget requests with the appropriate Core facility budget. Do not include the justifications with budgets in the front of the application. Provide the information necessary to document the level of effort on CFAR activities. The percent effort requested for the PI (CFAR Director), Co-Director (if applicable), and Core Directors should be limited to time devoted specifically to managing CFAR. The effort devoted to CFAR activities is expected to be above that spent on research grants. Please see the CFAR FOA.

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

Using this form, indicate the facilities at the applicant institution that 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 clearly indicate the name of the Department, Division or Institute identified in Item 9 of the Face Page of the application (page 1, PHS 398).

• Research plan - describe Core, aims, progress (if this is a renewal application), and planned activities in sufficient detail for evaluation by the peer review group.
• Describe the following policies and procedures:
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 generate program income from NIH grants of core users in most Basic and Clinical Cores to partially offset these expenses. Other methods, alone or in combination with this strategy, can be used but must be explained in sufficient detail.
2. Allocation of space
3. Percent effort of Core Directors
4. Selection of personnel
5. Objective evaluation criteria/outcome measurement
6. Selection and training. For Basic and Clinical Cores the process for selection of users, and training, if applicable.
7. For the Developmental Core the process of selecting developmental projects to be supported (e.g., the peer review process).
8. For the Developmental Core: the outcome evaluation of developmental projects
• Describe the following policies and procedures for Scientific Programs, if applicable
• Identification of Scientific Programs and Scientific Program Directors
• Program management, and identification of participants
• Criteria for program termination
• New projects defined by a program and sources of funding
• The objective evaluation criteria or outcome measurements
• Core Utilization

Describe the projects supported (one paragraph). Cite grant numbers listed in the Excel spreadsheet that show the NIH AIDS FRB of the institution(s). Cite Institute-specific programs supported by the Core, and be specific about how each Core provides or will provide support.

For Basic and Clinical Cores only, list proposed users and usage in percent of time expected for each major core user, using the “Core Users” table with each specific Core. For new applicants list proposed major users for each Basic and Clinical Core and their anticipated percent time usage. For renewal applicants, list the current users and their percent time usage.

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

For renewal applicants, provide a list of all literature citing a Core or CFAR that describes studies supported by the Core. When citing articles that fall under the Public Access Policy, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate "PMC Journal - In Process."

Developmental Core

In addition to the information above, describe the following:

For Renewal CFARs:

1. Outcome measurements for previous recipients of Developmental Core funding. Please use the table provided on Program Announcement.
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 pilot project applicants (new CFAR applicants) or recipients (renewal CFAR applicants), project titles and a brief description of the projects supported in the first year of Developmental Core funding.
2. If applicable, describe projects developed by Scientific Programs intended for funding in the first year of CFAR support. Include Project Director, other participating investigators, relevant research environment, budget, and research plan per the PHS 398 forms.
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

All activities must be assigned to a Core. Support for minority investigators for example, could be provided through a Developmental Core pilot project. A separate Core could be developed for foreign collaborations. For each additional activity indicate the leader of the project, the purpose, the first year plan, outcome measurements, and criteria for modifying funding in subsequent years.

Examples of additional activities:

• Foreign collaborations, including support for foreign investigators
• Development of minority scientists in AIDS research
• Mentoring and/or training new/junior investigators
• CFAR/CFAR collaborations
• Community outreach
• HIV/AIDS research communication, internal or external
• Industry collaborations

Scientific Programs

Describe the following:

• Scientific Program(s) that will be part of the CFAR
• Procedures for selection of Scientific Program Directors, members
• Procedures to encourage collaboration and identify scientific projects
• Procedures for review and funding of projects through the Developmental Core
• Procedures for continuation, termination, and rebudgeting of funds for projects, and identification of new project leaders in the event the need arises
• Specific projects to be funded in year 1 should be described under the Developmental Core.

Institutional Commitment (see FOA)

• 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) of the CFAR Director(s)
• Financial and other resource support for the CFAR that will be provided by the applicant institution(s)
• Authority or influence that the CFAR Director(s) has or will have over additional HIV/AIDS projects, facilities and space, as well as decision-making authority for hiring/approving new faculty and support personnel

Literature Cited

Provide a composite list of references. Please use the PMC reference number if available as described previously.

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. Appendix material must be provided on CD only, and five identical CDs should be included in one package with the application. Please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html for more information.

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

Checklist

Place at the end of the application package. Please be sure to check off the correct box for the type of application (e.g., competing continuation = renewal, revised application = resubmission, never had a CFAR/D-CFAR = new or substantial changes after an 01A1 or 01A2 = new. Please contact Program if you are not clear on which box to check.

Other

NIH Policy on Submission of Additional Grant Application Materials can be found on http://grants1.nih.gov/grants/guide/notice-files/not-od-08-082.html.

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