Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
Fogarty International Center (FIC), (http://www.fic.nih.gov)
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
 
Title:  Centers for AIDS Research and Developmental Centers for AIDS Research (P30) 

Announcement Type
This is a reissuance with modifications of PAR-06-291 published in the NIH Guide, March 29, 2006.

Update: The following update relating to this announcement has been issued:

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, seehttp://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-09-103

Catalog of Federal Domestic Assistance Number(s)
93.213, 93.242, 93.279, 93.393, 93.394, 93.396, 93.839, 93.855, 93.856, 93.865, 93.989

Key Dates
Release Date: February 13, 2009
Letters of Intent Receipt Date(s): May 14, 2010
Application Submission Dates(s): (changed to June 30, 2010 per NOT-AI-10-025), Original Date: June 15, 2010
Peer Review Date(s): September 2010
Council Review Date(s): October 2010 (Changed to January 2011 per NOT-AI-10-033)
Earliest Anticipated Start Date(s):  March 2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: (New Expiration Date July 1, 2010 per NOT-AI-10-025), Original Date: June 16, 2010


Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. 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 Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing   
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements

3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Participating Institutes of the National Institutes of Health (NIH) invite applications for Center Core grants (P30) to support Centers for AIDS Research as either standard CFARs (CFAR) or Developmental CFARs (D-CFAR).  CFAR cores provide infrastructure and promote basic, clinical, behavioral and translational HIV/AIDS research activities at institutions that receive significant HIV/AIDS funding from NIH Institutes or Centers.  CFARs can foster synergy and improve coordination of research, support emerging research opportunities, and promote efficiencies through resources shared by multiple independent laboratories.  CFARs and D-CFARs are intended to promote all HIV/AIDS research efforts at CFAR institutions.  D-CFARs provide support to assist investigators in the development of a competitive CFAR.  This Funding Opportunity Announcement (FOA) also defines a process for CFAR competitive supplements.  Before preparing an application to support a CFAR or D-CFAR, investigators are urged to consult with the Program staff listed in Section VII under "Agency Contacts: Scientific/Research Contacts."

Definitions

Throughout this FOA, P30 applications are abbreviated as "CFAR applications" and the corresponding P30 awards to support CFARs are abbreviated as "CFAR awards."  "Core" or "core facilities" are defined as entities providing services or expertise to be shared by multiple independent laboratories.  NIH CFAR awards support administrative, developmental, basic science, and clinical science cores for HIV/AIDS research. HIV/AIDS research includes HIV/AIDS and HIV/AIDS-related research.

Background

The CFAR program was established in 1988 and renewed in 1993, 1997, 2000, 2004, and 2006.  In May 1999, an ad hoc external review committee convened by the Office of AIDS Research reviewed the CFAR program.  Suggestions made by the review committee at that time remain incorporated within this current FOA.  The mission of the CFAR program and mechanisms for achieving this mission were developed by the CFAR Directors in 1995 and revised in 1996, 1998, and in the 2002 Position Statement of the NIH CFAR Directors.  (http://www3.niaid.nih.gov/LabsAndResources/resources/cfar/about/mission.htm)

The CFAR mission is to support multi-disciplinary environments that promote basic, clinical, epidemiological, behavioral, and translational research in the prevention, detection, and treatment of HIV infection and AIDS. The CFAR program accomplishes this mission by:

Additional information about CFAR goals and objectives and how they are to be addressed in the application may be found under Section IV.2. Content and Form of Application Submission.  Information concerning research objectives that are specific to D-CFAR applications follows that for CFAR applications.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity announcement (FOA) will use the NIH Center Core grant (P30) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).  A detailed categorical budget for the “Initial Budget Period” and the “Entire Proposed Period of Support” is to be submitted with the application.

The NIH P30 mechanism is for a Center Core grant that provides support for shared resources and facilities for a multidisciplinary research team or group of investigators focusing on a common research topic.  Funded independently of a center’s component or program projects, the core grant provides accessible resources.

This FOA is being issued by Fogarty International Center (FIC), National Cancer Institute (NCI), National Center for Complementary and Alternative Medicine (NCCAM), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), and National Institute of Mental Health (NIMH). Applicants may wish to contact each of the NIH components listed in “Agency Contacts” (Section VII) to find out about other funding opportunities that support research activities that can potentially benefit from and contribute to a CFAR program.

The National Center for Research Resources (NCRR), National Institute on Aging (NIA), National Institute of Dental and Craniofacial Research (NIDCR), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) also have an interest in, and support research on the topics covered.

Institutes and Centers at NIH use different grant mechanisms to support their portfolios of research; the components listed here may not use all of the mechanisms specified for this FOA.  Applications submitted in response to this funding opportunity will be assigned to the National Institute of Allergy and Infectious Diseases.

This FOA describes two types of CFAR awards.  The first is for a Developmental CFAR (D-CFAR) for HIV/AIDS investigators at an institution that is eligible, but does not yet have a CFAR.  The D-CFAR will provide the support necessary to develop a collaborative network that may permit the institution to be more competitive for a standard CFAR award.  The second type of award is for a standard CFAR (CFAR).  Both the D-CFAR and the CFAR are funded through the P30 mechanism for infrastructure development.  This FOA describes requirements for both types of CFARs.  Sections for the D-CFAR describe characteristics unique to this award. 

2. Funds Available

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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
The number of awards will vary from year to year depending on the quality of meritorious applications received, and programmatic priorities.

The size, duration, and maximum funding level of each award will depend on the type of CFAR award as described below.  The maximum funding level is determined by the NIH AIDS-funded research base (FRB), described in Section III, of an institution or group of institutions.  A CFAR cannot use the FRB of an institution that is already part of another CFAR.  The FRB of the previous fiscal year (defined as beginning October 1) to which an application is submitted will be used to determine eligibility.

D-CFAR: For institutions with a minimum FRB of $6M, a D-CFAR award will use a base of $750,000, total cost each year. 

CFAR: For institutions between the minimum FRB of $6M and less than $40M, a CFAR award will use a base of $1.5M, total cost each year.  For institutions with a minimum FRB of $40M but less than $80M, a CFAR award will use a base of $2.25M, total cost each year.  For institutions with a minimum FRB of $80M, a CFAR award will use a base of $3M total cost each year.

D-CFAR and CFAR comparisons are as follows:

D-CFAR

CFAR 

Competing and non-competing CFAR applications are limited to requesting a 3% increase over the total funding level of their most recent funding year regardless of previously estimated funding levels for that year.

The total project period for CFAR and D-CFAR grants may not exceed five years, and applicants are encouraged to apply for five years.

CFARs will be awarded and administered by the NIAID.  However, a CFAR award will consist of funds from multiple NIH Institutes.  Management oversight of the CFAR grants will be provided through an NIH CFAR Steering Committee composed of representatives from the co-funding NIH Institutes and Centers, and from the Office of AIDS Research (OAR).  It is therefore suggested that the applicant contact the Program representatives listed under ”Agency Contacts” in Section VII to discuss general CFAR issues, and how CFARs can enhance the HIV/AIDS research mission of the co-funding NIH Institutes and Centers.

The earliest anticipated start dates are as follows: March 2011 and March 2012.

Applications for competitive supplements (described in Section IV.2. Content and Form of Application Submission) may be requested, depending upon funding availability.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:  

Foreign institutions are not eligible for support as the primary awardee under the P30 mechanism, as described in the NIH Grants Policy Statement (http://grants1.nih.gov/grants/policy/nihgps_2003/index.htm), but may be subawardee components of U.S. applications.

1.B. Eligible Individuals

Any 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 for NIH programs.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

CFAR- and D-CFAR-specific Eligibility Requirements:

1) NIH AIDS Funded Research Base

To be eligible for a CFAR award an institution must have a significant NIH AIDS-funded research base (FRB).  The FRB is defined as the amount of Total Cost funding from NIH for one fiscal year (October 1 to September 30) preceding the calendar year of application submission.  For the D-CFAR and CFAR awards, an FRB in excess of $6M is required.  In addition, CFAR applicants must maintain the required minimum FRB during the year of submission in order to be funded at the requested amount.  For example, if an applicant has an FRB in 2008 that makes them eligible for $2.25M in funding, they must maintain the required FRB for funding at the $2.25M funding level in 2009 in order to be funded at that level.  This applies only to competing applications.

The research base includes peer-reviewed HIV/AIDS program projects, research grants, and cooperative agreements utilizing the following mechanisms only:  P01, R00, R01, R03, R18, R21, R21/R33, R24, R33, R34, R35, R37, U01, U10, U19, U24, U54, and K series awards.  Excluded from the NIH AIDS FRB are all funds from any source other than NIH.  A CFAR cannot use the FRB of an institution that is already part of another CFAR. Furthermore, for grants that are more than $5M, the awarded institution can only take credit for the amount that is budgeted for their institution.  The rest of the funds will not count toward their FRB or the FRB of the subcontracted institution(s). The NIH AIDS FRB is compiled on the OAR spreadsheet that is provided through the NIAID.

2) One CFAR award per institution

No institution will receive more than one CFAR award. An institution participating in a multi-institutional CFAR application may not be included in any other CFAR application. Independent campuses that are part of a large multiple city university are considered to be separate institutions, and each may submit one application.  Applicants are encouraged to contact program staff listed under "Agency Contacts" (Section VII) for additional guidance. 

3) Guidelines for multi-institutional CFARs 

In some cases two or more institutions that can demonstrate a credible plan for collaborative research networks using CFAR cores may wish to submit an application for a single CFAR award.  The request for multi-institutional applications should include the following indicators:

Multi-institutional CFAR applications may combine the NIH AIDS-funded research of all the investigators at the institutions participating in the proposed CFAR to meet the NIH AIDS-Funded Research Base requirement.  A multi-institutional CFAR application must designate a lead institution that will receive the award and provide details of agreements regarding coordination and support of cores and activities at other participating institutions.

CFARs that use a distant institution for a core facility may not use the Funded Research Base of any single investigator at that institution if they are not including all of the NIH AIDS investigators at that institution as part of the CFAR.

4) Cores outside of the CFAR institution

With appropriate justification, CFAR awards may support a core at an institution that is not part of the CFAR, including a foreign institution that provides a unique resource such as a clinical site, or a primate facility.  NIH AIDS funding of the investigators at this core facility is not included as part of the FRB of the CFAR (see Funded Research Base).

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

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. 

Renewals.  Applicants for standard CFARs may submit a renewal application.  Renewals are not permitted for D-CFARs. Successful D-CFARs must submit a new, full CFAR application.

Section IV. Application and Submission Information


1. Address to Request Application Information

The current PHS 398 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) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.


2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Applications 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.

The title and 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 must be checked.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): May 14, 2010
Application Submission Dates(s): June 15, 2010
Peer Review Date(s): September 2010
Council Review Date(s): October 2010
Earliest Anticipated Start Date(s):  March 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information: 

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 in
Section IV.3.A.

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616

6700B Rockledge Drive
Bethesda, MD 20892-7616

Bethesda, MD 20817-7616 (for express/courier service; non-USPS mail)
Telephone: (301) 496-8426
FAX: (301) 480-2408
Email:
pjackson@niaid.nih.gov

3.B. Sending an Application to the NIH

Applications 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 five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal 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:

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616

6700B Rockledge Drive
Bethesda, MD 20892-7616

Bethesda, MD 20817-7616 (for express/courier serice; non-USPS mail)
Telephone: (301) 496-8426

FAX: (301) 480-2408
Email:
pjackson@niaid.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt/ date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not 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.

Information on the 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

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are 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

Applicants for P30 grants must follow special application guidelines in the CFAR document entitled ADVICE ON PREPARATION OF A CFAR APPLICATION; this document is available via the WWW at: http://www3.niaid.nih.gov/LabsAndResources/resources/cfar/. Applications that are not received as a single package on or by the receipt date or that do not conform to the instructions contained in PHS 398 Application Kit (as modified in, ADVICE ON PREPARATION OF A CFAR APPLICATION) will be judged incomplete and will not be reviewed.  Please check the NIH web site at http://grants.nih.gov/grants/forms.htm for the current version of the PHS 398 Application Kit.

Page Limitations and Format of Overall Research Plan and Core/Scientific Working Group Sections:

Overall Research Plan :

Section Title

Instructions

1. Introduction

One page maximum. (Resubmissions and Standard CFAR Renewals only)

2. Specific Aims

One page maximum.

3. Research Strategy

Limited to 30 pages. Figures and illustrations may be included but must fit within the 30-page limit. Do not include links to Web sites for further information. Do not include animations.

Applicants must align their discussion to the following in the indicated order:

a. Significance
b. Innovation
c. Approach

Preliminary Studies for New Applications

Progress Report for Renewal/Revision Applications

Cores and Scientific Working Group Research Plan:

Section Title

Instructions

1. Introduction

One page maximum. (Resubmissions and Standard CFAR Renewals only)

2. Specific Aims

One page maximum.

3. Core/Project Research Strategy

Limited to 12 pages. Figures and illustrations may be included but must fit within the 12-page limit. Do not include links to Web sites for further information. Do not include animations.

Applicants must align their discussion to the following in the indicated order:

a. Significance
b. Innovation
c. Approach

Preliminary Studies for New Applications

Progress Report for Renewal/Revision Applications

Excluded from the page limitations of the Overall Research Strategy and Cores/Projects sections are the following items:

Human Subjects Sections

Other Research Plan Sections

Although this information will be discussed, these other sections should not be used to circumvent the page limits.

Spreadsheets, Tables, and Website

NIH will provide applicants with a spreadsheet (Excel) electronically via email indicating all investigators receiving NIH AIDS funding at an applicant's institution (or institutions if a multi-institution application), arranged by NIH Institute and Center.  These spreadsheets are prepared by the Office of AIDS Research (OAR) and are usually available in March or April.  In the first column of the spreadsheet applicants should indicate those investigators who have formally agreed to participate in the CFAR, and the primary type of participation expected.  Applicants should develop their own key table to abbreviate the type of participation(s) for each CFAR Member (i.e., Core Director = CD, core user = CU, attends seminars = S, etc.) and indicate the participation type in the first column.  This spreadsheet should be included in the Administrative Core of the application in the Resources section.

It is important that the CFAR be inclusive of the full range of HIV/AIDS research funded at a given institution.  Therefore, review committees will be interested in why some investigators listed in the spreadsheet may have chosen not to be part of the CFAR.  Applicants may also indicate investigators at their institution(s) who will become part of the CFAR but who were not included in the spreadsheet.  The reason for inclusion, or exclusion, of a given investigator should be addressed.  A brief explanation should be included at the bottom of the table as to why investigators may not be participating as CFAR members.

The NIH will provide tables for additional information required of both new and resubmission applications.  These may be found at the CFAR Funding Opportunity Announcement website: http://www3.niaid.nih.gov/LabsAndResources/resources/cfar/.     

Every CFAR site should establish its own CFAR website that describes the Core facilities available at the CFAR, the services provided by each Core, and the contact information for the CFAR Director/Co-Director, Administrator, and Core Directors.

Research Strategy Page Limitations

APPLICATION FORMAT

The following information and instructions should be considered when preparing an application for the CFAR or D-CFAR award.  Included here is the rationale, based on CFAR goals and objectives, for the information being requested in the application and how it is to be provided.

I. CFAR added value.

CFARs are expected to provide added value to the applicant institution's HIV/AIDS research efforts through support of activities that cannot easily be provided through standard research grants/awards.  CFARs should promote and encourage activities that enhance collaboration and coordination of HIV/AIDS research.  CFARs promote translational research activities, i.e., studies bringing findings of the laboratory to the clinic, and vice versa.

Examples of how added value can be measured include, but are not limited to:

II. CFARs should serve the research needs of NIH-funded HIV/AIDS investigators at the applicant institutions.

Cores aims and services should address the needs of HIV/AIDS investigators at the applicant institution(s) and be inclusive of the full range of HIV/AIDS science funded at the applicant institution(s).  Applicants should describe in detail the operation of each proposed core, i.e., its quality control, procedures, safety, training, etc., and how the proposed policies and procedures protect and incorporate the divergent needs of CFAR investigators (see additional details concerning policies and procedures under "V.1. CFAR and D-CFAR Overall Research Strategy”).  Applicants are encouraged to contact Program staff listed under "Agency Contacts" in Section VII. Agency Contacts to discuss strategies being planned for how the CFAR will foster collaboration among HIV/AIDS investigators from divergent disciplines.  Applicants for renewal CFARs should describe how different NIH-funded HIV/AIDS programs, if funded at the institution, will participate in the CFAR.  Specific programs funded by the co-funding institutes are listed under "Administrative Core”.

III. CFARs have scientific and fiscal flexibility.

CFARs have the responsibility to use their resources to meet the needs of their investigators.  A CFAR has the authority to change allocation of resources according to the guidelines of CFAR operating policies and procedures.  A CFAR has considerable flexibility and authority to alter funding of a Basic or Clinical Core, to delete a core, or to initiate a new core.  Applicants should state what policies and procedures will be used as the basis for reallocation of initial core funds to permit the establishment of new cores, as needed, without additional funding.  Applicants should describe how proposed policies and procedures provide structure for decision-making on several levels, and how each of the following individuals or groups would participate in the decision process: Core Director, CFAR Director, internal advisory board, CFAR investigators, and external advisory board.  Applicants should also state the process for informing NIH of major changes in the CFAR.

The extent to which CFAR funding may leverage other resources in support of HIV/AIDS research is an important measure of a CFAR's value to HIV/AIDS investigators.  Basic and Clinical Cores may be supported totally, or in part, by CFAR funds. Applicants are encouraged to develop creative collaborations to improve utilization of existing resources.  Convincing justification will be required for duplication of any Basic or Clinical Core that exists in a similar form elsewhere in the applicant institution(s). Applicants should describe how cores with partial CFAR funding will be used to enhance the research of CFAR investigators. For example, a CFAR core supported by other funding (e.g., of an NIAID AIDS Clinical Trial Unit or an NCI Cancer Center core facility) may become more accessible to HIV/AIDS investigators through CFAR association and coordination.  Commitments for continued funding in the non-competitive continuation years of all NIH grants are dependent upon the availability of funds. Applicants should describe decision-making policies and procedures for “down-sizing” the CFAR if funding is decreased in continuation years.

Responsible management includes annual reporting of progress.  NIH has developed guidelines that specify the kind of information required in progress reports in order to answer questions from various constituencies, including Congress.  NIH staff will assess the previous progress reports from investigators submitting renewal applications, as well as responses to requests for additional information.  Results of this assessment will be made available to the applicant and if necessary, may also be considered when making final funding decisions.  Assessments will reflect general trends during the funding period, rather than any single outstanding or insufficient response.

IV. Additional CFAR-supported activities.

CFARs traditionally use a variety of strategies to achieve the objectives of the award.  Examples include industry collaborations, community outreach, development of minority scientists in HIV/AIDS research, mentoring young investigators, HIV/AIDS research communications to non-scientists, approach to problems in enrollment and retention of women and minority groups in AIDS clinical trials, international collaborations, additional support of ongoing NIH programs not planned in the initial award, CFAR-CFAR collaborations, and other activities that meet the HIV/AIDS research needs of applicant institutions.

Applicants are encouraged to explore collaborative, multi-institutional linkages with international and domestic sites and Historically Black Colleges and Universities (HBCUs) and international institutions.  Such linkages foster international research training and collaborative studies and are able to meet needs that cannot be easily addressed by other funding mechanisms.  Coordination with international programs funded by the Fogarty International Center (FIC) is strongly encouraged.  Contact information for the FIC Program Officer is provided under "Agency Contacts.”

Some examples of ways in which current CFARs are able to assist in the development of new investigators (including junior faculty and minority investigators at the CFAR institution(s), HBCUs, and both domestic and international institutions) are described below.  These examples are not meant to be all-inclusive.

CFARs have also started collaborating with each other in scientific areas of common interest to achieve economies of scale to share unique resources and expertise and to expand collaborative activities between CFARs, especially in areas that cannot be studied at a single CFAR site.  One example includes the CFAR Network of Integrated Clinical systems (CNICS), which is the first electronic medical records-based resource to include clinical data from the large and diverse population of HIV-infected persons receiving care at one of the CFAR sites. Another example is the CFAR Social and Behavioral Sciences Research Network (CSBRSN) that includes CFAR sites with Behavioral Cores and that hold annual meetings to share ideas, assist junior investigators, and promote new scientific collaborations. 

V. CFAR awards support four different types of cores: Administrative, Developmental, Basic Science, and Clinical Studies. 

Each CFAR must have a single Administrative and a single Developmental Core, and a minimum of one Basic and one Clinical Science Core to optimally support the HIV/AIDS research at the applicant institution(s).  The smallest CFAR would have a minimum of four cores that would consist of one of each type of core (Administrative, Developmental, Basic, and Clinical).  The terms Basic and Clinical Cores are generic, and the definition of what constitutes a Basic or Clinical Core is sufficiently broad to meet the needs of the applicant institution(s), and may vary among CFAR applicants.  For example, epidemiology, biostatistics, ethnography, and behavioral cores could be classified as either Basic or Clinical Cores, depending on their focus.  Clinical Cores will have more direct interaction with patients.

An applicant's initial choice of Basic and Clinical Cores is an important measure of the science management process.  Applicants should describe the Basic and Clinical Cores to be supported at the time that the CFAR is awarded, how the choice of cores was made, other potential cores that were evaluated but not selected, mechanisms for evaluating the utilization of proposed cores, and criteria for increasing or decreasing funding of these cores during the course of the award

1. Overall Research Strategy (30 pages)

Use this section to describe how the proposed Overall Research Strategy of the CFAR will contribute to meeting the goals and objectives of the CFAR Program as described above.  Also, explain the rationale for selection of the strategies, opportunities, action plan and outcome measurements proposed to accomplish the specific aims. 

Organize the Overall Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5.  Make sure to start each section with the appropriate section heading in order, Significance (e.g., Strengths), Innovation (e.g., Opportunities), Approach (e.g., Action Plan and Outcome Measurements) and include the appropriate information.  Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.  Progress reports for renewal and revision applications must be included as part of the approach section.

The Overall Research Strategy section describes the mission, goals, and overall specific aims of the CFAR in terms of its impact on HIV/AIDS research, innovative approaches in managing a complex multi-disciplinary, multi-institutional center, qualifications of the CFAR’s leadership, and establishment of a collaborative research environment.  This section should also describe the operational and organizational structure of the CFAR, indicate an implementation strategy to initiate, establish and maintain the CFAR organization, provide necessary background information, indicate institutional commitment, and describe how the proposed Cores will add value to what is already funded at the institution(s). 

Organize the Overall Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5.  Make sure to start each section with the appropriate section heading and suggested subheadings in the order, Significance (e.g., Overall Research Strategy, Strategic Plan and Strengths), Innovation (e.g., Opportunities), Approach (e.g., Action Plan and Outcome Measurements) and include the appropriate information.  Applicants must not only address the section heading criteria (Significance, Innovation, Approach; in that order), but must align their discussion of the Overall Research Strategy to these criteria. Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.  Progress reports for renewal and revision applications must be included as part of the approach section.

The Overall Research Strategy section should include a Strategic Plan that identifies the most significant scientific opportunities and gaps at the applicant institution targeted for the CFAR in the short and long term, and identifies objective milestones that can measure success or failure.

Awardees will be required to carry out and report on an ANNUAL basis the strategic planning process being used to assess current and expected scientific and fiscal needs and planned adjustments, according to the CFAR or D-CFAR policies and procedures that each Center will develop and implement (See II. Administrative Core). 

The Strategic Plan should include and address the following:

Strengths - Describe the strengths of the CFAR including a summary of research of CFAR participants and the current facilities and resources available.  Use the Table, "Existing Core Facilities at the Institution Applying for a CFAR Award” (all applicants) to list all core facilities and those that will be used by the CFAR.  This table can be found on the CFAR Program Announcement web page: (http://www3.niaid.nih.gov/LabsAndResources/resources/cfar/).   Use the column labeled "Member" in the Excel table showing the NIH AIDS-Funded Research Base of the institution(s) to indicate how investigators whose funded grants contribute to the institution’s FRB will be participating in the CFAR.  Provide a brief explanatory sentence at the bottom of the table for any investigators who will not be participating.  Place this table in the Resources Section of the Administrative Core.  Recompeting applicants should describe how any major HIV/AIDS programs at the CFAR institution supported by co-funding NIH Institutes and Centers, are assisted by CFAR. 

Examples of programs are:

FIC:

AITRP, ICHORTA-AIDS/TB, GRIP. IRSDA, BIOETHICS TRAINING, FRAMEWORKS, ICOHRTA, INFORMATICS, BRAIN DISORDERS, STIGMA, GID, Clinical Research Training Scholars

NCI:

AMC, ACSR

NHLBI:

NHLBI-funded Programs

NICHD:

Ad health, ATN, Populations Studies Centers (R24)

NIDA:

NCCTN

NIAID:

HIV/AIDS Clinical Trials Networks, IPCP, MACS, WIHS, CHAVI, HIT-IT

NIMH:

Brain Bank, NIMH Centers Program

Opportunities - Identify and evaluate potential opportunities for use of CFAR funds. This analysis will probably require input for suggestions from all potential CFAR participants within that institution.

Action Plan - Choose the highest priority opportunities and develop a detailed plan for the first year of funding.  Examples of an action plan include determining which cores will be established; determining how existing cohorts will be utilized; identifying the categories of support for developmental projects, communication and outreach; and identifying the lectures and meetings the CFAR will sponsor.  Some CFARs may find that specific thematic areas emerge from this strategic planning process.  Development of an action plan that capitalizes on such programmatic themes is encouraged, but not required.

Outcome Measurements - Determine how progress on action plans will be measured.  Include anecdotal and objective measurements of how the CFAR infrastructure award provides "added value" or the unique contributions of CFARs that cannot be provided by research awards.  Select long-term goals for the funding period and annual milestones for the first year.

The ability to manage the CFAR award will be judged in part by the clarity and thoughtfulness of the scientific management strategies proposed for the Administrative and Developmental Core sections of the proposal. The annual strategic planning process for the selection and organization of additional cores through such methods as acquisition of information, outside support of cores, and participation of the HIV/AIDS investigators at the applicant institution(s) in core development and usage should be described in detail.

Institutional Commitment

Commitment of the CFAR institution is particularly important for the coordination of resources across the broad areas and potential boundaries of research supported by the co-funding Institutes and Centers.  Examples of the types of institutional commitment that are demonstrated at current CFARs are: level of institutional funding, space allocation, co-funding, endowments, and designation of center program status in the institutional bylaws.  These are examples and are not inclusive of other possible ways in which an institution may demonstrate support for the CFAR.  The applicant must provide a letter(s) from the appropriate institutional official(s) (e.g., Dean, President, or Provost) defining:

1.    Position, authority, and reporting responsibility (on the institution's organizational chart) for the CFAR Director

2.    Financial and other resource support for the CFAR that will be provided by the applicant institution(s)

3.    Authority or influence that the CFAR Director has, and/or will have over other HIV/AIDS projects, facilities and space, as well as decision-making authority for hiring and/or approving new faculty and support personnel.

Core and Scientific Working Group Research Strategy Section(12 pages each)

Use these sections to describe how the proposed Core activities will contribute to meeting the CFAR’s goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims.  In addition, this section should indicate the relevance of the core to the Overall Research Strategy of the CFAR application.

Organize the Core Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5.  Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information.  Applicants must not only address the section heading criteria (Significance, Innovation, Approach; in that order), but must align their discussion of each Core to these criteria. Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.  Preliminary Studies for new cores and progress reports for renewal and revision cores in a renewal or revision application must be included as part of the approach section.

2. Administrative Core (12 pages)

The Administrative Core is responsible for the overall administration, coordination and management of the Center.  The PD/PI of the application should be the Core Leader of the Administrative Core. The CFAR Administrative Core will be responsible for managing, coordinating, and supervising the entire range of Center activities, monitoring progress, and ensuring that the project milestones are being met and are being implemented effectively within the proposed timelines. A well-developed administrative plan is integral to the success of the Center and must be clearly defined in the application. The plan should include a discussion of the structure and roles of administrative staff, including the training and experience of proposed staff and the functions to be performed and a discussion on how the Center will ensure effective and timely communications between the Center and NIAID staff. In addition to the Core Leader (CL), the Administrative Core should have a CFAR administrator responsible for the daily administration. The Administrative Core must provide both an organizational and administrative structure that is conducive for ensuring collaborative efforts and interaction among the Cores and Scientific Working Groups.  This Administrative Core should clearly identify personnel and resources needed to oversee the Center and ensure management of the Cores and Scientific Working Groups. The core must provide a clear and explicit discussion of how fiscal and other resources will be prioritized, allocated, and managed (see Policies and Procedures below).  A description of how Cores and Scientific Working Groups will be managed, how communications such as periodic meetings and conference calls with minutes will be organized and managed should be provided. Each CFAR must have a well delineated organizational structure and administrative mechanisms that foster interactions among investigators, accelerate the pace of research, enable translation of basic research findings to clinical applications, and ensure a productive research effort.

Policies and Procedures 

Policies should be considered to be "a set of guiding principles of operation."  There are no "correct" policies, and different CFARs may adopt different polices.  Below are several examples of justifiable but not necessarily compatible policies that might be used to address funding issues. Funding issues are an example of an area that a CFAR considers in the development of policies and procedures

Procedures should be considered to be a set of specific actions used to conduct the affairs of the CFAR.  Procedures should specify how various tasks will be accomplished within the policy guidelines of the CFAR.  Policies and procedures should describe:

All information on the protection of human subjects, and the inclusion of women, children, and minorities should be included in the section entitled “Human Subjects” in the Administrative Core.  If there are details that pertain only to a specific Core, that additional information should also be included in the Human Subjects Section of that Core.  Each Core should reference the Administrative Core section as appropriate.  Human subjects protection issues on studies funded through other research grants should be addressed in those individual grant applications.  For example, if the CFAR provides Virology Core services for an HIV/AIDS Clinical Trial Unit for ACTG studies, all human subjects issues will be addressed in the ACTG studies and not in the Virology Core.

All clinical research supported by the CFAR and that uses CFAR infrastructure must follow the Office for Human Research Protections (OHRP) and NIH and NIAID guidelines for the protection of human subjects (http://grants.nih.gov/grants/policy/hs/index.htm). Thus, even though most clinical research conducted under the CFAR will be funded directly through other research grants, human subjects’ protection issues must be addressed not only on those grant applications, but also must be acknowledged in the CFAR application.  For clinical research involving human subjects, or data/sample collection and storage that are funded by the CFAR, applicants must provide all required documentation demonstrating protection of human subjects and IRB approval.  Please see the Clinical Core section for additional details.  For Developmental Cores that are expected to fund future awards for clinical research it is sufficient to state the policies and procedures that are in place to address the requirements at that time.  Please see the Developmental Core section for additional details.

Similarly, all animal research supported by the CFAR and that uses CFAR infrastructure must follow the Office of Laboratory Animal Welfare (OLAW) and NIH guidelines for the protection of animals.  Please see Basic Science Cores section for further details.

Applicants should ensure that the face page of the application is marked “yes” for human subjects if human subjects research is proposed and “yes” for vertebrate animals if animal research is proposed.  Failure to adequately address issues concerning human subjects and vertebrate animals could result in delayed funding should an application be recommended for funding.  Applicants must also address the policies and procedures for the CFAR’s data management by including the Data Sharing Plan (see below under “Resource Sharing Plan(s)”) in the Administrative Core.

3. Developmental Core (12 pages)

The intent of a CFAR Developmental Core is to support scientific studies for short periods of time to develop preliminary data for peer-reviewed research applications. Four general areas are eligible for support through the Developmental Core: (1) investigators who are new to HIV/AIDS research and have not previously received independent research awards such as an R01 in HIV/AIDS research; (2) feasibility studies; (3) emerging research opportunities; and (4) HIV/AIDS research activities of newly recruited faculty. High priority for developmental awards should be given to junior faculty.  Prior approval from NIH Program staff is required for developmental awards to senior investigators.  The Developmental Core may be used to fund a collaborative study that encompasses two different scientific disciplines that may not have collaborated previously.  Applicants may wish to consult with Program staff listed under "Agency Contacts" to discuss how Developmental Cores are used at current CFARs. 

While the CFAR Administrative Core should focus on the mechanisms for allocation of developmental funds and for annual evaluation of supported activities, the CFAR Developmental Core should describe the mechanism to be used for identification, peer-review selection, and outcome evaluation of projects to be supported within this Core.  The Developmental Core Director is responsible for ensuring that all developmental studies involving human or animal subjects have the appropriate approvals (i.e., IRB, FWA, IACUC, human subjects’ research training, etc. in domestic and foreign institutions).  Applicants must inform the NIH of any awards made for developmental studies involving foreign sites prior to initiation. Developmental studies involving foreign sites cannot be initiated without first obtaining NIH clearance and approvals for protection of human subjects and animals, including specimens.  Similarly, the NIH may ask for additional information for clinical research studies funded by the CFAR for final clinical review and approval.

The Developmental Core section should include a plan for the use of the first year developmental funds.

Applicants who have current CFARs should describe outcome evaluation of previously funded developmental projects. The time period should include all years for which the CFAR was funded.  The applicant should use the “Previous Recipients of Developmental Awards Table” provided for this purpose on the CFAR Funding Opportunity Announcement web site (http://www3.niaid.nih.gov/LabsAndResources/resources/cfar/interested/) and include it with the application.

4.  Basic Science Cores (12 pages each)

Basic Science Cores provide equipment, training, services, quality control, and expertise/advice for research activities that cannot easily be funded through standard research granting mechanisms.  Basic Science Cores should provide economy of scale through use by multiple laboratories and should foster collaboration between basic and clinical investigators.  Basic Science Cores do not substitute for resources that are obtainable commercially, or replace existing resources normally supported by individual research grants.  Cores should have a clear focus, and contribute to translational research.  Applicants must emphasize well managed and efficient core functions above the overall number and breadth of cores in a given application.  Please use the CFAR Table "Existing Core Facilities at the Institution Applying for a CFAR Award” to indicate all core facilities at your institution and whether or not CFAR members will be utilizing them.

CFAR applications should describe the Basic Science Cores to be supported at the time of the award and any changes anticipated during the course of the award.  A Basic Science Core should be designed to support multiple HIV/AIDS investigators, and applicants should indicate the number of anticipated users and the percent time of use by each.  Mechanisms should be described to prioritize core usage even if prioritization is not currently required, evaluate use annually, and justify level of continued CFAR support in the context of evolving scientific priorities at the applicant institution(s).

Applicants are reminded of the PHS398 (or current NIH form) requirement to address the involvement of vertebrate animals in the work proposed.  CFAR Cores proposing direct work with vertebrate animals must provide full Vertebrate Animals Research sections as per PHS398 instructions.

5.  Clinical Cores (12 pages each)

Clinical Cores should focus clearly on providing resources for HIV/AIDS translational research between collaborating clinical and basic scientists.  The primary distinction between a Basic and Clinical Core is that a Clinical Core involves direct (e.g., intervention for a behavioral or biomedical study) or indirect interaction (e.g., developing a database for clinical specimens) with human subjects.  Activities that will not be supported by a CFAR Clinical Core are normal patient care, including screening of clinical specimens, diagnosis, treatment, or rehabilitation.

Mechanisms should be described for prioritizing core usage even if prioritization is not currently required, evaluating use annually, and justifying the level of continued CFAR support in the context of evolving scientific priorities at the applicant institution(s).

Applicants are reminded of the PHS398 (or current NIH form) requirement to address the involvement of human subjects in the work proposed.  Any new work involving human subjects proposed in the Clinical Core sections of this application that are not covered by existing IRB approvals will require such approvals prior to funding.  CFAR Cores proposing direct work with human subjects must provide a Human Subjects Research plan as per PHS398 instructions and forms.

6. PROGRAM INCOME SYSTEM

Each CFAR Core, where appropriate, is encouraged to phase in a Program Income System, a method of charging users of the Core Facility a fee commensurate with their usage of equipment, time, supplies (such as reagents) and personnel, if any, providing the service.  The program income costs would then be budgeted within the users' research grants, resulting in a gradual increase in funds from this source, and a decreased cost to the CFAR over the award period.  These freed funds from the CFAR award, originally dedicated to establish the Core Support Facilities proposed in the initial application, could then be rebudgeted and may require prior approval from the NIH to the Developmental Core, and/or be used to establish new Cores or expand existing Cores as the Center evolves.  Applicants should be aware that program income may be generated.

The CFAR is strongly encouraged to establish a "Program Income" plan by the end of the first year of award and to include it in the non-competing continuation application for the second year and in each subsequent non-competing year.  Program income should be described for all applicable Cores.

7. Scientific Working Groups (12 pages total for all Scientific Working Groups Proposed)

A Scientific Working Group is defined as a specific area of scientific focus for a group of investigators who share common research interests and goals and participate in competitively funded research.  CFARs are encouraged, but not required, to identify one to three Scientific Working Groups in order to (1) take full advantage of the ability of CFARs to organize HIV/AIDS research at an institution, (2) encourage collaboration among scientific disciplines and diverse areas of expertise, and (3) explore significant questions and problems in HIV/AIDS that are not being addressed.  Each Scientific Working Group  should capitalize on areas of excellence at that particular CFAR and should encourage interdisciplinary collaboration among investigators who have not previously collaborated with each other, or within that area of scientific focus.  Examples of possible Scientific Working Groups include, but are not limited to: HIV/TB Co-infection, pregnancy in the context of HIV prevalence, HIV/AIDS and Sexually Transmitted Infections (STIs), New Treatment Approaches for HIV/AIDS, Molecular Modeling Approaches to Vaccine Development, HIV in Women and Sex/Gender Differences in HIV Infection or Disease Progression, and HIV-associated Malignancies.  The examples provided are meant to be broad enough to include diverse biomedical disciplines, e.g., behavioral science, epidemiology, pathogenesis, clinical research, etc., but are focused clearly in a specific research area.  A Scientific Working Group serves to unite a subgroup of CFAR scientists, whereas essential Cores are used by all or most CFAR members and provide services and expertise.  Applicants must address clearly the interaction between the Scientific Working Group(s) and the CFAR Cores. 

The Scientific Working Group Director is expected to encourage new collaborations, identification of high risk/high impact studies, submission of new proposals for peer-reviewed funding, and address knowledge gaps that cannot be addressed by standard funding mechanisms.  The success of a Scientific Working Group will ultimately be measured by expansion of NIH-supported funding for the Scientific Working Group, and the establishment of successful collaborations within and between the Scientific Working Group and CFAR Cores.  The Scientific Working Group should be of adequate size and scientific quality, should exhibit a high degree of interaction, are encouraged to be multi-disciplinary, and should be capably led.  To ensure adequate size and quality, a proposed Scientific Working Group  must have the equivalent of at least three entire peer-reviewed and funded research projects, each led by a separate, independent Principal Investigator.  Peer-reviewed, funded research sub-projects of larger Program grants (e.g., P01s) may be counted as separate projects.  Peer-reviewed awards that may be used to comprise a Scientific Working Group will come from the Funded Research Base of the CFAR.  Methods to develop collaborations will vary at each CFAR, but may include formal or informal planning meetings, seminars and retreats, new resources, shared resources, or key recruitments. 

It is possible that a Scientific Working Group may achieve its stated goals, such as new funding, and the CFAR may then decide to refocus resources on a new Scientific Working Group.  Specific policies and procedures for determining when and how new Scientific Working Groups will be started, terminated, or extended should be explained clearly by the applicant.  Having clear outcome measures for established Scientific Working Groups is strongly encouraged.  Decision-making for development of new Scientific Working Groups undertaken solely by the CFAR Director and Core Directors is strongly discouraged.

There are three possible ways for Scientific Working Groups to fund new collaborative projects: (1) through new peer-reviewed funded research, (2) with CFAR base funding through the Developmental Core as described in the Developmental Core, and (3) through supplements to the CFAR grant as explained below.

The Scientific Working Group Director and colleagues within a CFAR Scientific Working Group are strongly encouraged to identify innovative, high-risk/high impact projects as a strategy to increase collaboration among CFAR investigators.  Proposed projects are encouraged to be multi-disciplinary.  The following are examples of scientific projects that suggest, but are not intended to limit, a variety of collaborations that could be considered: 

Funding for the Scientific Working Group Director position(s) can be requested in the budget for development of the Scientific Working Group(s) through the Administrative Core.  CFAR funding for collaborative projects will be through the Developmental Core, either from base CFAR funds, or through a competitive supplement to the CFAR grant.  At the time of submission, applicants should identify a Scientific Director(s), the Scientific Working Group(s), and specific plans that will be used to develop collaborative activities.  In addition, procedures for identifying scientific studies, reviewing applications, and choosing studies to be supported for each Scientific Working Group, should be clearly identified.  Policies for continuing, terminating/revising, or rebudgeting funds for a project should be clearly identified in the event that the Scientific Director leaves the institution, the study achieves an earlier endpoint than expected, or other unexpected data or results become available that suggest a change in focus.  These policies will be evaluated by the reviewers to determine the ability of the applicant to manage funds responsibly for the projects during the CFAR funding period, and will be incorporated into the terms and conditions of award if the CFAR application is successful. 

The CFAR strategic planning process should be used to develop policies and procedures for identifying and prioritizing projects, and to develop funding plans for projects to be funded through the Developmental Core using base CFAR funding.  Funding for these projects is expected to be greater than for standard developmental awards, and must be fully justified. 

Before developing this part of the application, investigators are strongly encouraged to discuss plans with appropriate NIH representatives identified under "Agency Contacts."

Competitive Supplements.  To provide additional encouragement for new collaborative studies, NIH Institutes and Centers that co-fund CFARs may, on an annual basis, solicit for competitive supplements to the CFAR grant for scientific projects.  In addition, the NIH CFAR Program, and the Office of AIDS Research may solicit competitive supplements for collaborative projects in areas identified by the NIH and NIH Advisory groups, together with suggestions from CFAR investigators.  Both of these funding mechanisms are subject to funds available each year; and funding opportunities, if available, will be announced on the NIH CFAR web site, or by email communication to eligible CFARs.

8. CFAR Budget Items

A.  Core BudgetsCore budgets may include equipment, supplies, support contracts, and other necessary expenses.  All items should be fully justified for allocation of CFAR funds.

B.  Other Administrative Costs

This category includes the costs necessary for the central administration and fiscal management of the CFAR, including relevant and reasonable costs for reprints, graphics, and publications for Developmental Core users.

C.  Travel

CFAR Directors' Meeting(s) — Attendance at the Annual CFAR Directors’ Meeting is required of the CFAR Director and the CFAR Administrator.  Under extenuating circumstances a Core Director may attend in lieu of the CFAR Director.  The CFAR Director is required since this is the venue for discussions on policy issues, new information related to the CFAR program and the potential for CFAR-to-CFAR scientific collaboration.  One senior scientist per center may also receive financial support for the Annual CFAR Directors’ Meeting.  Additional funds may be reallocated for other CFAR meetings during the year at the NIH, at a CFAR site, or at the site of a scientific conference that most of the Directors plan to attend.  Applicants should include travel funds specifically for these meetings in the CFAR Administrative Core budget request. 

Other Travel — With justification, applicants may request travel funds in addition to those required for the two Directors' meetings, for CFAR-related activities.  For example, travel could be used to promote collaboration among CFAR investigators and HIV/AIDS investigators not part of a CFAR Program, or at distant cores for meetings of Core Directors of similar cores to share operational and scientific expertise, and for participation of junior investigators or investigators from resource-limited settings at CFAR-collaborative meetings and workshops.  CFAR funds can be used for international travel to promote collaboration or to establish CFAR International Cores and/or International Scientific Programs between the CFAR research community and investigators working in resource-limited settings.

Travel funds should not be used for travel to scientific meetings, nor should they be used for advertising and promotion.  The one exception is for junior investigators with no other funding who have received a CFAR developmental award.  These investigators may receive CFAR funds in order to attend a meeting to present the results from their CFAR developmental award.  CFAR funds cannot be used to provide travel scholarships for investigators without a CFAR developmental award.

These additional travel funds should not exceed $40,000 annual direct costs.  The procedures that the CFAR will follow on determining the use of these funds should be described clearly in the “Policies and Procedures” section of the Administrative Core.

D.  Definition of Effort for CFAR Directors and Core Directors

The effort requested should be limited to time devoted specifically to managing CFAR activities and not to research.  The effort devoted to CFAR activities should be above that spent on research grants. Information documenting the level of effort on CFAR activities must be included in the application. All requested personnel costs should be carefully justified.

The effort of the CFAR Director should be justified in the context of the Director's other responsibilities.  Administrative support (a secretary or an administrative assistant), which would otherwise be allowable only as a Facilities and Administrative Cost, should be requested for the CFAR office only for matters directly pertaining to the CFAR and must be well justified.

Core Directors are CFAR members who are responsible for the overall technical excellence of a core facility.  The CFAR-supported percent effort of Core Directors involved in research activities should only include core management time.  The CFAR may support technical staff to provide CFAR services in core facilities. 

The use of Developmental Core funds for junior faculty salary support is allowed.  Established investigators with Research Project Grants (R01 or equivalent) are expected to have salary support from other sources.

TABLES

All required Tables should be placed in the Resources Section of the relevant Core using the Resources Format Page of the PHS 398 form.  All other Tables and Tables submitted as part of the Overview of Application Section should be included in the Resources section of the Administrative Core using the Resources Format Page of the PHS 398 form.

DEVELOPMENTAL CFARs (D-CFAR)

The purpose of the D-CFAR is to provide support for pre-CFAR applicants to develop collaborations, experiment with core facilities that may be important to support HIV/AIDS investigators at the institution, and to correct any deficiencies that might adversely affect an application for a standard CFAR award.  The emphasis for D-CFAR is on the identification and clear description in the application of gaps or deficiencies that would hinder development of a competitive CFAR application, and core facilities that will reduce or eliminate these gaps.  For example, applicants may wish to initiate HIV/AIDS studies with investigators in resource-limited settings, or expand collaborations between behavioral science and basic science investigators at an institution that has traditionally had a more narrow scientific focus in HIV/AIDS and HIV/AIDS-related research.  Other examples include expansion of communications technology among investigators who have begun, or are planning, collaborative studies, using the Developmental Core to fund a collaborative study that encompasses two scientific disciplines, especially two that may not have previously collaborated (behavioral scientists developing AIDS prevention interventions, and clinicians conducting clinical trials of AIDS therapeutics), or developing an outreach program that could not be started through institutional or research grant funding.  The D-CFAR mechanism may not be used to obtain a supplement to an existing CFAR award.

All eligibility requirements and specific descriptions provided in this FOA for the CFAR applications are also required for, and relevant to, the D-CFAR applications.  The minimum number and type of cores for a D-CFAR are the same as for a standard CFAR: one Administrative, one Developmental, one Basic and one Clinical.  There are several differences between a D-CFAR and a standard CFAR. The maximum base funding level for the D-CFAR award is $750,000 total costs and it is a one-time award for 5 years.  We encourage independent HIV/AIDS investigators interested in expanding collaborative efforts at their institution to consider applying for this award.

Applicants who have never received a CFAR award are eligible to apply, as are previous CFAR applicants who have not been successful in competing for an award, and previous recipients who were not successful in renewing their CFAR award.  Applicants who have not received a CFAR award may choose to apply for either a standard CFAR or developmental CFAR (D-CFAR) award. 

Applicants should clearly indicate in the application title and in the abstract that the application is for the D-CFAR award.  If no indication is provided it will be assumed that the application is for a standard CFAR.  Because the D-CFAR is designed to assist the applicant in the organization and development of a competitive CFAR application, reviewers will look very carefully at summary statements from previous CFAR applications from the same applicant regarding the feasibility of overcoming obstacles identified by previous reviewers. Note that a resubmitted application also must address prior reviewer critiques in the introductory section. 

Applicants applying for a D-CFAR award should plan on providing as much detail for the Administrative and Developmental Cores as is required for the standard CFAR application.  Please see the instructions for the Administrative and Developmental Cores for CFARs, above.  The strategic plan should provide sufficient detail about procedures that will be used to identify challenges at the institution and proposed solutions that would lead to development of a competitive CFAR application within the five-year funding period.  Proposed outcome measurements for strategies and core facilities selected for year 1 should be clearly defined, as well as the procedures for making adjustments to the plan in years 2 through 5 if necessary.

Like the standard CFAR award, a D-CFAR provides funding to foster synergy and improve coordination of research, to support emerging research opportunities, and to promote economy of scale through resources shared by multiple independent laboratories.  D-CFARs also encourage other activities that serve the requirements of HIV/AIDS research.  See Part IV. ”Additional CFAR supported activities” in Section IV.6. Other Submission Requirements and Information.  Any of these activities may be fostered through a D-CFAR award.

Appendix Materials

All paper 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.

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

Resource Sharing Plan(s)

NIH 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 must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: 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. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:  

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

In addition to the above review criteria, the following CFAR-specific criteria will be addressed and considered in the determination of scientific merit and the rating. These review criteria are based on the mission of the CFAR Program and mechanisms for achieving this mission.  In addition, evidence of successful performance from applicants that have had CFAR awards or similar programs at their institutions will be included in the evaluation.

Specific review criteria for this FOA have been added to ensure that the major components of a CFAR application are evaluated appropriately.  The score should reflect the overall impact that the CFAR could have on the field in consideration of the five criteria (Significance, Investigators, Innovation, Approach and Environment), with emphasis on each criterion varying from one application to another, depending on the focus of the application and its relative strengths.  Note that an application need not be strong in all categories to be judged likely to have major scientific impact and thus deserve an outstanding impact/priority score.  For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.  Review criteria are listed below separately for the standard CFAR (CFAR) and the developmental CFAR (D-CFAR) applications as well as for the individual Scientific Working Groups.

SPECIFIC REVIEW CRITERIA FOR STANDARD CFARs

Significance – The effect that a CFAR award would have on CFAR investigators'

HIV/AIDS research efforts

1.    Will the Cores have the ability to support the research base, foster synergy, enhance HIV/AIDS research collaborations and produce an economy of scale as best evidenced by specific CFAR-supported increases in research productivity across the entire NIH AIDS Funded Research Base (FRB)?

2.    What evidence is provided that demonstrates the CFAR will enhance proposed scientific communication, outreach, training efforts, international collaborations, and collaborations with industry?

3.    Will the Developmental Core procedures demonstrate function and effectiveness in selecting projects and performing outcome evaluations?

Investigators – The identification of appropriate leaders to carry out the CFAR mission

1.    Do(es) the CFAR Director(s) have appropriate managerial experience, commitment, and leadership both in HIV/AIDS research and at the applicant institution(s)?

2.    Do the selected Core Directors and key personnel have appropriate qualifications, competence and commitment?

Innovation – The utilization of CFAR resources in unique ways to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s)

1.    Within the CFAR structure is there a degree of variety across the disciplines involved in HIV/AIDS research projects, and are they committed to participation and coordination within the D-CFAR according to the application?

2.    Does the CFAR propose unique ways to incorporate resources (cores, projects, cohorts, trials etc) and to support resources with CFAR and non-CFAR funds in order to achieve the scientific goals stated in the application?

Approach – The quality of the CFAR scientific planning and management process

1.    Does the annual strategic planning process adequately cover CFAR scientific and management plans?

2.    Do the policies and procedures for evaluating cores reassigning funding priorities, and for developing and utilizing outcome measurements, reflect the quality of the CFAR scientific planning and management process?

3.    Do the methods for selecting Basic and Clinical Core users and for prioritizing their use reflect the quality of the CFAR scientific planning and management process?

Environment – The likelihood that the environment is supportive and will assist a CFAR in achieving its objectives

 1.    Is there evidence that the CFAR provides added value to HIV/AIDS research conducted at the institution?

2.    Is there adequate Institutional commitment, including space, financial support and other resources and oversight for CFAR activities?

3.    Is there previous history of CFAR support for developmental projects and outcomes?

4.    Is there previous history of translational research efforts?

5.    Does the structure and strategy of the budgets proposed for the CFAR overall and the individual cores demonstrate that the applicant understands the complexity, need for flexibility, and and scope of the infrastructure porposed?

6.    Is there evidence of community involvement and outreach?

In addition to the above review criteria, the following criteria for significance should be applied to standard CFAR applications with base budget requests of $2.25M or $3M.

1.    Is there evidence that the CFAR provides significant capacity-building support for: junior faculty, minority investigators, investigators from resource-limited settings, and new collaborations in HIV/AIDS, including CFAR-CFAR collaborations that would not be possible without the CFAR?

 2.    Is there need for coordination of HIV-related science at the institution, and is there an ability of the CFAR to serve as the primary coordinating unit for the institution(s)’s HIV-related science?

3.    Is there inclusion of unique policies and procedures for obtaining assessments from HIV/AIDS investigators about the CFAR’s ability to meet their research needs?

SPECIFIC REVIEW CRITERIA FOR D-CFARs

Significance – The effect a D-CFAR award would have on an applicant's HIV/AIDS research efforts

1.    Is there evidence that the proposed D-CFAR will lead to development of a competitive standard CFAR application?

2.    Do the Cores demonstrate capability to support the research base, foster synergy, enhance HIV/AIDS research collaborations and produce an economy of scale?

3.    Do proposed scientific communication, outreach, training efforts, international collaborations, and collaborations with industry demonstrate capability to assist HIV/AIDS investigators to foster the development of a competitive CFAR application?

Investigators – The identification of appropriate leaders to carry out the D-CFAR mission

1.    Does the selected D-CFAR Director have appropriate managerial experience, commitment, leadership in HIV/AIDS research and location at the applicant institution?

2.    Is the selection of Core Directors and key personnel with appropriate qualifications, competence and commitment appropriate?

Environment – – The likelihood that the environment is supportive and will assist a CFAR in achieving its objectives

1.    Is there evidence for a D-CFAR providing added value to HIV/AIDS research conducted at the institution?

2.    Is there Institutional commitment, including space, institution financial support and other resources and oversight provided for D-CFAR activities?

Does the structure and strategy of the budgets proposed for the D-CFAR overall and the individual cores demonstrate that the applicant understands the complexity, need for flexibility, and scope of the infrastructure proposed?

Innovation – Unique utilization of D-CFAR resources to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s)

1.    Within the D-CFAR structure is there a degree of variety across the disciplines involved in HIV/AIDS research projects, and they are committed to participation in and coordination within the D-CFAR structure according to the application?

2.    Is there an incorporation of resources (Cores, projects, cohorts, trials, etc.) in the D-CFAR and  a description of the extent to which they are/are not D-CFAR supported in the application?

3.    Is there evidence that the proposed D-CFAR goals are well matched to the available resources and will foster future collaborative interactions?

4.    Is the proposed strategy for expanding the D-CFAR’s focus a unique utilization of resources to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s)?

Approach – The quality of the CFAR scientific planning and management process

1.    Is there evidence of an annual strategic planning process?

2.    Are there policies and procedures to evaluate Cores and reassign funding priorities; outcome measurements?

3.    Are there methods for selecting Basic and Clinical Core users and for prioritizing use?

4.    Are there policies and procedures for identifying gaps and the mechanisms to fill them?

5.  Are there developmental Core procedures for selection of projects and outcomes evaluation?

SPECIFIC REVIEW CRITERIA FOR SCIENTIFIC WORKING GROUPS AND PROPOSED STUDIES (for both CFAR and D-CFAR)

Significance – The effect that a collaborative project would have on the overall HIV/AIDS effort at the institution

1.    Is there evidence for innovative, high-risk/high-impact scientific working group(s) and project(s) that will address significant problems or gaps in the HIV/AIDS field that cannot be addressed easily through other funding mechanisms?

2.    Is there evidence that the proposed scientific working group(s) and project(s) will enhance new multidisciplinary collaborations, and that they may include international collaboration, collaboration with industry, or collaboration with junior or minority investigators or investigators new to the HIV/AIDS field?

3.    Is there evidence that the process for selecting scientific working group(s) and project(s) to be funded will lead to independent funding of high-risk/high-impact studies?

Investigators – Identification of appropriate scientists to lead the recognition and development of collaborative scientific working groups and projects

1.    Is the selection of the Scientific Director(s) appropriate for the proposed Scientific Working Group?

2.    Is the selection of the project leaders for the individual proposed collaborative projects appropriate?

Innovation – The identification of a unique Scientific Working Group and project or approach to solve a significant question or gap in HIV/AIDS research

1.    Is the breath of scientific disciplines that are included in the proposed Scientific Working Group(s) and scientific project(s) sufficient to solve a significant question or gap in HIV/AIDS research?

2.    Is the degree of innovation in Scientific Working Group and project selection and experimental design appropriate to solve a significant question or gap in HIV/AIDS research?

Approach - The quality of the CFAR Scientific Working Group(s) and project(s), including planning and management process

1.    Are the project design and Scientific Working Group selection appropriate?

2.    Are there appropriate policies and procedures to identify and select Scientific Working Group(s) and project(s), reassign funding priorities, and measure outcome of Scientific Working Group(s) and project(s)?

Environment

1.    Is appropriate scientific expertise available?

2.    Is there previous history of institutional support for developmental projects and outcomes?

3.    Is the effort budgeted for the Scientific Director appropriate?

4.  Is there evidence that the scientific collaborative areas, scientific working groups and projects arise from the scientific environment at the CFAR institution(s)?

Additional Review Criteria 

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.  For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications.  When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations 

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations.  Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Total cost limitations and total award for CFAR and D-CFAR grantees are based on the grantee’s FRB.  However, it is expected that reviewers will use the structure and strategy of the budgets as one measure of the ability of the CFARs to manage their program during the funding period.  Reviewers may make suggestions or recommendations to NIAID regarding changes in the structure or strategy of resources within total cost limitations.  Likewise reviewers may make suggestions or recommendations about cost however cost is not considered in the scoring of the application.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

This award will include special terms and conditions that differ from the agency's usual terms and conditions. See also  Section IV.5. , “Funding Restrictions.”

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the
NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NOA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

A formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization. The NOA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of   Award will be mailed to the business official.

2. Administrative and National Policy Requirements

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

No funds may be provided for projects involving foreign sites unless specifically indicated on a revised NOA. This includes developmental awards that have foreign involvement.  If developmental awards involve international studies, prior approval must be obtained from NIAID Program and Grants Management staff.

The Terms and Conditions of Award will incorporate the following items proposed by the applicant with potential modifications based on recommendations made by the peer review group:      

Any subsequent modifications to the NOA will require concurrence of NIH.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The NIH has developed guidelines for providing information it needs to obtain from progress reports in order to respond to constituencies, including Congress.  Awardees can obtain a copy of this guidance document from the NIH CFAR website (http://www3.niaid.nih.gov/LabsAndResources/resources/cfar/).  Awardees’ annual progress reports must include a description of ongoing, completed, and planned activities, as well as accomplishments during the previous funding/reporting period.  This also includes progress utilizing supplements awarded previously through the CFAR program.  The progress report should also include the tables that are available on the CFAR website (http://www3.niaid.nih.gov/LabsAndResources/resources/cfar/ ). 

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Please check the following website for any changes in contact information:  http://www3.niaid.nih.gov/LabsAndResources/resources/cfar/.   

For questions regarding D-CFAR, or CFAR management issues, scientific issues, or program interests of NIAID please contact:

Ann Namkung Lee, M.P.H.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4211, MSC-7626
6700-B Rockledge Drive
Bethesda, MD 20892-7626
Telephone: (301) 496-9176
FAX: (301) 402-3211
Email: an107z@nih.gov    

For questions regarding D-CFAR, or CFAR scientific issues or program interests of other NIH Institutes or Centers please contact:

FIC

Jeanne McDermott, Ph.D.
Division of International Training and Research
Fogarty International Center
Room B2C39, MSC-2220
31 Center Drive
Bethesda, MD  20892-2220
Telephone: (301)-496-1492
FAX: (301) 402-0779
Email:  mcdermoj@mail.nih.gov 

NCI

Geraldina Dominguez, Ph.D.
AIDS Malignancy Program
Office of HIV and AIDS Malignancy
National Cancer Institute
31 Center Drive, Room 3A35
Bethesda, MD  20852
Telephone: (301) 496-3204
FAX:  (301) 480-4137
E-mail: domingug@mail.nih.gov

NCCAM

Sheila Caldwell, Ph.D.
Division of Extramural Research and Training
National Center for Complementary and Alternative Medicine
Suite 401, MSC-5472
6707 Democracy Boulevard
Bethesda, MD 20892-5475
Telephone: 301-435-6286
Fax: 301-480-3621
Email:  caldwells@mail.nih.gov

NHLBI

Cheryl L. McDonald, M.D.
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 8114, MSC-7940
6701 Rockledge Drive
Bethesda, MD 20892-7940
Telephone: (301) 435-0560
Email: McDonalC@nhlbi.nih.gov

NICHD

Kevin W. Ryan, Ph.D.
Center for Research for Mothers & Children (CRMC)
National Institute of Child Health & Human Development
Room 4B11D, MSC-7510
6100 Executive Boulevard
Bethesda, MD 20892-7510
Telephone: (301) 435-6871
FAX: (301) 496-8678
Email: kryan@mail.nih.gov

NIDA

Jag Khalsa, Ph.D.
Division of Pharmacotherapies and Medical Consequences of Drug Abuse
National Institute on Drug Abuse
Room 4137, MSC-9551
6001 Executive Boulevard
Bethesda, MD 20892-9551
Telephone: (301) 443-2159
FAX: (301) 594-2599
Email:  jk98p@nih.gov 

NIMH

Christopher, Gordon, Ph.D.
Division of Mental Disorders, Behavioral Research & AIDS
National Institute of Mental Health
Room 6204, MSC-9621
6001 Executive Boulevard
Bethesda, MD  20892-9621
Telephone: (301) 443-1613
FAX: (301) 443-9719
E-mail: cg206o@nih.gov   

2. Peer Review Contacts:

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616

6700B Rockledge Drive
Bethesda, MD 20892-7616

Bethesda, MD 20817-7616 (for express/courier serice; non-USPS mail)
Telephone: (301) 496-8426
FAX: (301) 480-2408
Email:
pjackson@niaid.nih.gov

3. Financial or Grants Management Contacts:

Deanna L. Ingersoll
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2262, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone:  (301) 451-2686
FAX: (301) 493-0597
Email: ingersolld@niaid.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (
http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (
http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see
http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (
http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at
http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (
http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


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