Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Allergy and Infectious Diseases (NIAID) National Cancer Institute (NCI) National Heart, Lung, and Blood Institute (NHLBI) National Institute on Aging (NIA) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Fogarty International Center (FIC)
Funding Opportunity Title	Centers for AIDS Research and Developmental Centers for AIDS Research (P30)
Activity Code	P30 Center Core Grants
Announcement Type	Reissue of PAR-09-103
Related Notices	December 18, 2013 - This PAR has been reissued as PAR-14-041.
Funding Opportunity Announcement (FOA) Number	PAR-11-108
Companion FOA	None
Number of Applications	Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.242, 93.279, 93.393, 93.394, 93.396, 93.839, 93.855, 93.856, 93.989, 93.865
FOA Purpose	This FOA encourages applications for the Centers for AIDS Research (CFAR) program to provide administrative and shared research support to enhance HIV/AIDS research. Applications are being solicited for both standard CFARs and for developmental CFARs (D-CFARs). Standard and D-CFARs provide core facilities, expertise, resources, and services not readily obtained otherwise through more traditional funding mechanisms. Additionally, D-CFARs provide support to assist investigators in the development of a competitive standard CFAR. The program emphasizes interdisciplinary collaboration, especially between basic and clinical investigators, translational research between the laboratory and the clinic, inclusion of investigators from diverse backgrounds, and inclusion of prevention and behavioral change research.

Posted Date	February 9, 2011
Letter of Intent Due Date	May 13, 2011, May 14, 2012 and May 14, 2013
Application Due Date(s)	June 14, 2011, June 14, 2012 and June 14, 2013 , by 5:00 PM local time of applicant organization
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October, 2011, October, 2012 and October, 2013
Advisory Council Review	January, 2012, January, 2013 and January, 2014
Earliest Start Date(s)	April, 2012, April, 2013 and April, 2014
Expiration Date	June 15, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

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 and D-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 and D-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 standard 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

This FOA will use the NIH Center Core grant (P30) award mechanism. 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 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.

D-CFARs qualify for a base of $750,000 total cost in the first year as determined by the $6M minimum required funded research base (FRB) for the institution.

Standard CFARs qualify for three tiers of funding based on the FRB for the institution.

• Tier 1: For institutions with a minimum of $6M, but less than $40M FRB, a CFAR award will use a base of $1.5M total cost in the first year of the competing segment.
• Tier 2: For institutions with a minimum of $40M but less than $80M FRB, a CFAR award will use a base of $2.25M total cost in the first year of the competing segment.
• Tier 3: For institutions with a minimum of $80M FRB, a CFAR award will use a base of $3M total cost in the first year of the competing segment.

Throughout this FOA, the terminology used for P30 applications for both CFARs and D-CFARs is "CFAR applications" and the corresponding terminology for P30 awards to support CFARs and D-CFARs is "CFAR awards." "Core" or "core facilities" are defined as entities providing services or expertise to be shared by multiple independent laboratories. All eligibility requirements and specific descriptions provided in this FOA for the CFAR applications also apply to D-CFAR applications. The FOA does, however, provide some specific review criteria that only applies to D-CFAR applications. Standard CFAR and D-CFAR applications have the same minimum number and types of Cores, namely: one Administrative, one Developmental, one Basic Science and one Clinical Science Core.

The FOA also describes the concept of a Scientific Working Group. 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. Although, CFAR and D-CFAR applications require a minimum of four Cores as described in the previous paragraph, Scientific Working Groups are optional for both CFAR and D-CFAR applications.

Background

The CFAR program was established in 1988 and renewed in 1993, 1997, 2000, 2004, 2006, and 2009. The mission of the CFAR program and mechanisms for achieving the mission were developed by 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 mission of CFAR 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:

• Providing scientific leadership and institutional infrastructure dedicated to HIV/AIDS research
• Stimulating scientific collaboration in interdisciplinary and translational research
• Strengthening capacity for HIV/AIDS research in resource-limited settings
• Fostering scientific communication
• Sponsoring training and education
• Promoting knowledge of CFAR research findings and the importance of HIV/AIDS research through community outreach
• Promoting and supporting innovative NIH HIV/AIDS research initiatives
• Establishing collaborative research between and among CFARs, and supporting HIV/AIDS research networks
• Facilitating technology transfer and development through promotion of scientific interactions between CFARs and industry
• Supporting research on prevention and treatment of HIV infection in hard-to-reach populations, especially inner city, rural poor, and disadvantaged minorities.

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 grant awards. The added value contribution that the proposed CFAR will make at the institution(s) should go beyond what would be expected from the pre-existing AIDS funded research. CFARs should promote and encourage activities that enhance collaboration and coordination of HIV/AIDS research. An appropriate goal for CFARs is to promote translational research activities, i.e., basic scientists provide clinicians with new tools for use in patients and for assessment of their impact, and clinical researchers make novel observations about the nature and progression of disease that often stimulate basic investigations.

Some examples of how added value can be measured include:

• Developmental Core awards resulting in collaborations, publications, or successful major research grants
• Interdisciplinary publications
• Evidence of CFAR enhancement and support of existing programs at the institution
• Research activities initiated to address prevention and treatment questions in hard-to-reach populations (inner city, rural poor, and disadvantaged minorities)
• Development and utilization of a program income mechanism (see PROGRAM INCOME SYSTEM in Section IV.6) for Cores
• The initiation of institutional support for activities previously supported by the CFAR.
• Mentoring and training of young investigators.
• Promoting and supporting new collaboration and moving the HIV/AIDS field forward through CFAR-sponsored meetings and activities.

CFARs are expected to serve the research needs of NIH-funded HIV/AIDS investigators at the applicant institutions. The aims of the Cores and the services they provide 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 that 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 " Overall Research Strategy ).

Applicants are encouraged to contact Program staff listed under "Agency Contacts" in Section VII. Agency Contacts to discuss planned strategies for fostering collaboration among HIV/AIDS investigators from divergent disciplines within the proposed CFAR. Applicants for renewal CFARs should describe how other 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 the "Overall Research Strategy in Section IV.6.

CFAR awards support four different types of cores: Administrative, Developmental, Basic Science, and Clinical Science. Each CFAR must have one Administrative and one 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 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 are likely to 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, criteria for increasing or decreasing funding of these cores, and process for adding or deleting cores during the course of the award.

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 in that they can alter funding of a Basic or Clinical Core, delete a core, or 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 (e.g., CFAR Director, Core Director(s), internal advisory board, external advisory board, and CFAR investigators), and how each of the individuals or groups would participate in the decision process. Applicants should also state the process for informing the 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 leveraging of existing resources by the CFAR.

Responsible management includes annual reporting of progress. NIH has developed guidelines that specify the kind of information required in annual 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 be considered when making final funding decisions. Assessments will reflect general trends during the funding period, rather than any single outstanding or insufficient response.

CFARs have the option to incorporate Scientific Working Groups. 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. 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.

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 scientists from diverse backgrounds underrepresented in in HIV/AIDS research, mentoring young investigators, HIV/AIDS research communications to non-scientists, CFAR-sponsored seminars and meetings, development of approaches to problems in enrollment and retention of women and minority groups in AIDS clinical trials, international collaborations, identifying additional support for 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, Historically Black Colleges and Universities (HBCUs) and international institutions. Examples of linkages include mentoring, collaborating, and training. Such linkages foster 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. CFARs also collaborate 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. Examples of inter-CFAR collaborations can be found on the CFAR website (see http://www.niaid.nih.gov/LABSANDRESOURCES/RESOURCES/CFAR/Pages/collaborations.aspx).

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 expected in a D-CFAR application will be the identification and clear description of gaps or deficiencies that would hinder development of a competitive CFAR application, and Core facilities that would 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-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 study that encompasses two scientific disciplines (especially two that may not have previously collaborated), or developing an outreach program that could not be initiated with institutional or research grant funding

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 below). Any of these activities may be fostered through a D-CFAR award.

Additional Budget Information

The size 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 in the first year.

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

D-CFAR and CFAR comparisons are as follows:

D-CFAR

FRB/BASE FUNDING: =$6M of FRB/$750K Total Cost in first year

FUNDING PERIOD: up to 5 years

COMPETITIVE RENEWAL: Not allowed

FOCUS: compete for a standard CFAR

CFAR

FRB/BASE FUNDING:

=$6M/$1.5M Annual Total Cost in first year

=$40M/$2.25M Annual Total Cost in first year

=$80M/$3M Annual Total Cost in first year

FUNDING PERIOD: 5 years

COMPETITIVE RENEWAL: Allowed

FOCUS: support NIH HIV/AIDS investigators at an institution

Non-competing CFAR and D-CFAR Progress report budget requests are limited to a 3% increase over the total costs of their most recent award regardless of previously committed 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.

Funding Instrument	Grant
Application Types Allowed	New Renewals are allowed for CFARs. Renewals are not permitted for D-CFARs. Resubmission The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The total amount awarded and the number of awards will depend upon the funds available, the quality of the applications received, and programmatic priorities. The number of awards will vary from year to year depending on the quality of meritorious applications received and programmatic priorities.
Award Budget	An applicant may request a project period of up to 5 years. For D-CFAR applications, $750,000 total costs per center per year will be awarded. For standard CFAR applications, up to $3M total costs per center per year will be awarded. The total amount awarded will depend on the applicant institutions NIH AIDS-funded research base.
Award Project Period	Scope of the proposed project should determine the project period. The maximum period is 5 years.

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.

Higher Education Institutions:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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 support.

Only one PD/PI may be designated on the application.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

CFAR- and D-CFAR-specific Eligibility Requirements:

1) NIH AIDS Funded Research Base (FRB)

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 2010 that makes them eligible for $2.25M in funding, they must maintain the required FRB for funding at the $2.25M funding level in 2011 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 applicant cannot use the FRB of an institution that is already part of another CFAR. Furthermore, for grants in the FRB 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 from the OAR database and can be requested by the applicant institution to determine eligibility. More information can be found in Section IV.6 under the heading Spreadsheets, Tables, and Website.

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:

• a demonstration of exceptional need to establish collaboration between multiple investigators at each of the applicant institutions
• evidence of unique plans, such as the development of organized communications systems to overcome the scientific and management challenges that are naturally a part of multi-institutional collaborations
• specific plans to address any anticipated budgetary challenges in the transfer of funds and resources from one institution to another
• evidence for centralized authority of the CFAR Director for the purpose of management of the CFAR facilities at other sites

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).

5) D-CFAR application

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 D-CFAR award.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research (including whether it is a CFAR or D-CFAR application).
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should 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 service; non-USPS mail)
Telephone: (301) 496-8426
FAX: (301) 480-2408
Email: pjackson@niaid.nih.gov

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three 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)

At the time of submission, two additional paper copies of the application and all copies of the appendix files 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 service; non-USPS mail)
Telephone: (301) 496-8426
FAX: (301) 480-2408
Email: pjackson@niaid.nih.gov

All page limitations described in the PHS398 Application Guide must be followed, with the following exceptions or additional requirements:

Overall Research Plan:

Section Title	Instructions
1. Introduction	One page maximum. (Resubmissions only)
2. Specific Aims	One page maximum
3. Overall 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.

Cores and Scientific Working Group Sections:

Section Title	Instructions
1. Introduction	One page maximum. (Resubmissions only)
2. Specific Aims	One page maximum per Core and single page for the Scientific Working Groups.
3. Core/Scientific Working Group(s) Research Strategy	Limited to 12 pages per Core and a single 12 page section for the Scientific Working Groups. Figures and illustrations may be included but must fit within the stated 12-page limit. Do not include links to web sites for further information. Do not include animations.

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

Human Subjects Sections

• Inclusion Enrollment Report
• Protection of Human Subjects
• Inclusion of Women and Minorities
• Targeted/Planned Enrollment
• Inclusion of Children

Other Research Plan Sections

• Vertebrate Animals
• Select Agents Research
• Consortium/ Contractual Arrangements
• Letters of Support
• Resource Sharing Plans
• Progress Report Publication List (for Renewal Applications)
• References/Literature Cited

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

SUGGESTED TABLE OF CONTENTS

The following Table of Contents format is suggested:

ITEM	PAGE
INITIAL APPLICATION SECTION
Face Page
Description, Project/Performance Sites, Senior Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cell statement if applicable.
Table of contents (with page numbers) Do not use PHS Form Page 3.
Detailed Budget for First Year
Cumulative Budget for All Years of Proposed Period of Support
Detailed Budget for Each Core
Budgets Pertaining to Consortium/Contractual Arrangements
Biographical Sketch Format Page
Checklist
OVERALL RESEARCH PLAN SECTION
Resources and Environment
Introduction to the Application*
Specific Aims*
Overall Research Strategy*
Letters of Support
INDIVIDUAL CORE RESEARCH PLAN SECTION (Include for Administrative Core, Developmental Core, and each Basic and Clinical Core)
Description, Project/Performance Sites, Senior Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells
Resources and Environment
Introduction to Application*
Specific Aims of Core*
Research Strategy*
Inclusion Enrollment Report (Renewal or Revision Applications Only)
Bibliography and References Cited/Progress Report Publication List
Protection of Human Subjects
Inclusion of Women and Minorities
Targeted/Planned Enrollment Table
Inclusion of Children
Vertebrate Animals
Select Agent Research, if applicable
Resource Sharing Plan(s)
SCIENTIFIC WORKING GROUPS RESEARCH PLAN SECTION
Description, Project/Performance Sites, Senior Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells
Resources and Environment
Introduction to Application*
Specific Aims of Scientific Working Group*
Research Strategy*
Inclusion Enrollment Report (Renewal or Revision Applications Only)
Bibliography and References Cited/Progress Report Publication List
Protection of Human Subjects
Inclusion of Women and Minorities
Targeted/Planned Enrollment Table
Inclusion of Children
Vertebrate Animals
Biohazards
Select Agent Research, if applicable
Resource Sharing Plan(s)
APPENDIX (Five identical CDs)

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Note: Applicants should clearly indicate in the application title and in the abstract that the application is for a CFAR or D-CFAR award. If no indication is provided, it will be assumed that the application is for a standard CFAR.

I. Overall Research Strategy (30 pages)

Use this section to describe the proposed Overall Research Strategy and the Strategic Plan of the CFAR and how it 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.

The Overall Research Strategy should also describe the strengths of the CFAR including a summary of research of CFAR participants and the current facilities and resources available.

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, IICHORTA-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:	Add health, ATN, PHACS, Populations Studies Centers (R24)
NIDA:	CTN
NIAID:	HIV/AIDS Clinical Trials Networks, MACS, WIHS, CHAVI, IeDEA
NIMH:	Brain Bank, NIMH Centers Program

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.

Significance. The effect that a CFAR award would have on CFAR investigators HIV/AIDS research efforts.

• Succinctly summarize HIV/AIDS science at the institution or institutions that justifies the need for CFAR support. 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.
• Describe how the CFAR provides added value to HIV/AIDS research conducted at the institution(s).
• Demonstrate the CFAR’s ability to support the research base, foster synergy, enhance HIV/AIDS research collaborations, and produce an economy of scale.

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

• Provide the degree of variety across the disciplines involved in HIV/AIDS research projects within the CFAR structure.
• Describe the unique ways resources (e.g., cores, cohorts, trials, technology, etc.) are incorporated and supported in the CFAR.
• Illustrate unique ways to incorporate community involvement and outreach in the CFAR.
• Identify and evaluate potential opportunities for use of CFAR funds.

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

• Describe the CFAR organizational structure in the parent and any collaborating institutions.
• Provide an organizational chart for all CFAR components, directors, and Core directors.
• Describe the leadership plan for the CFAR. This should include a rationale for choosing a multiple CFAR Director approach. The roles and responsibilities of the CFAR Director(s) and CFAR Core Directors should be described.
• Describe the major locations of CFAR activities, including those in collaborating institutions and discuss distances between locations. You may also wish to provide a chart or map illustrating the location and setting of the CFAR parent institution in relation to collaborating institutions, especially if there are Cores that are located outside of the parent institutions (e.g., Cores in a different country), and describe the functional relationships.
• Develop an action plan that capitalizes on the highest priority opportunities and develop a detailed plan for the first year. 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.
• Determine how progress on action plans will be measured (i.e. outcome measurements). Include anecdotal and objective measurements of how the CFAR infrastructure award provides "added value" or the unique contributions of the CFAR that cannot be provided by research awards. Select long-term goals for the funding period and annual milestones for the first year.
• Progress Report (for renewal applications)

Letter of Institutional Commitment

• The applicant must provide a letter(s) from the appropriate institutional official(s) (e.g., Dean, President, or Provost) defining:
  • Position, authority, and reporting responsibility (on the institution's organizational chart) for the CFAR Director
  • Financial and other resource support for the CFAR that will be provided by the applicant institution(s)
  • Authority or influence that the CFAR Director has, 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.

II. Core (12 pages each) and Scientific Working Groups (12 pages combined) Research Strategy Section

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. Please Note: Potential members of the Scientific Working Group(s) (except for the PI or key personnel from Cores) are NOT to be named in the application. For renewal CFARs only, name the current members of the SWGs.

Significance. The effect that a Core would have on CFAR investigators HIV/AIDS research efforts.

• Describe how the CFAR Core provides added value to HIV/AIDS research conducted at the institution(s).
• Demonstrate the Core’s ability to support the research base, foster synergy, enhance HIV/AIDS research collaborations, and produce an economy of scale.
• Provide evidence that the Core enhances proposed scientific communication, outreach, training efforts, international collaborations, and collaborations with industry as applicable.
• Describe the strengths of the 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 the Core.

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

• For Basic and Clinical Cores, describe projects supported in one paragraph.
• Cite Institute-specific programs supported by the Core, and be specific about how each Core will provide support.
• For Developmental Core:
  • If you are a new applicant -- provide a list of potential pilot projects.
  • If you are a renewal applicant -- provide project titles and a brief description of the projects supported in the first year of funding of the Developmental Core.

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

• Develop an action plan that capitalizes on the highest priority opportunities and develop a detailed plan for the first year.
• Determine how progress on action plans will be measured (i.e. outcome measurements).
• Core Policies and Procedures
  • Roles in Decision-making Processes
  • Reporting Processes
  • Annual Strategic Planning Processes
  • Allocation of Core budgets
    • Plans for managing resources to enable functioning of the Cores
    • Process for reallocating funds within the Core as research needs change
    • Applicants should describe decision-making policies and procedures for down-sizing the CFAR if funding is decreased in continuation years.
  • Allocation of space
  • Prioritization of services (Basic & Clinical Cores)
  • For the Developmental Core
    • Process of selecting developmental projects to be supported (e.g., the peer review process)
    • Process for mentoring investigators who are or are not successful in obtaining developmental project funding
    • Process for training early stage investigators in grant writing and scientific review
    • Procedures for review and funding of projects for Scientific Working Groups, if applicable
    • Outcome evaluation of developmental projects (use the Previous Recipients of Developmental Awards Table (Excel).
    • Progress Report (for renewal applications)

Additional Instructions for Cores and Scientific Working Groups

For the Research Strategy Section (Cores and Scientific Working Groups) describe how the proposed 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. This section should indicate the relevance of the Core to the Overall Research Strategy of the CFAR application.

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 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 allocated for the establishment of Core Support Facilities proposed in the initial application, could consequently be rebudgeted (may require prior NIH approval) to the Developmental Core, and/or be used to establish a new Core(s) 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.

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

Other administrative costs may include those 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.

Travel to 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 from the CFAR budget 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.

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 for the Cores. All required Tables should be placed in the Resources Section of the relevant Core using the Resources Format Page of the PHS 398 form.

D-CFAR instructions. 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 and below. 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.

Required CFAR Cores

A. Administrative Core

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.

• CFAR funding allocated by discipline in proportion to research performed in those disciplines
• CFAR funding allocated for projects based on a majority vote of all members in an individual CFAR
• CFAR funding allocated for projects based on majority vote of an internal advisory board

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:

• the proposed roles of the CFAR Director, Core Directors, CFAR investigators, advisory boards, and institutional officials in the decision-making process
• the annual strategic planning process; examples of issues CFAR members should consider:
  • how funds will be allocated to all types of cores and activities
  • procedures for changes in support of any cores
  • how CFAR-sponsored conferences, seminars, workshops, and other activities will be identified
  • how priorities for communication, outreach and additional CFAR activities will be established
  • how Cores, Core Directors, leaders of additional CFAR activities, internal and external advisory committees will be selected and evaluated
  • the plans for leadership succession
  • the authority and responsibility of internal and external advisory committees
  • membership of Advisory committees
  • how developmental projects are selected and evaluated
  • how cores are selected and reports are developed, including the annual strategic plan and the noncompeting continuation application
• policies and procedures for identifying new Scientific Working Groups, and eliminating Scientific Working Groups after they either have achieved their goals or the Scientific Working Group has been deemed unproductive
• other mechanisms used to determine HIV/AIDS basic and clinical research core needs at the applicant institution(s), assigning priorities to potential cores, and selecting the Basic and Clinical Cores to be included in the application

Spreadsheets, Tables, and Website. Include the required spreadsheets and tables in the Resources section of the Administrative Core).

• 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.
• 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 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.
• 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/).

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.

All applicants should ensure that the face page of the application is marked yes for human subjects. If animal research is proposed, applicants should mark yes for vertebrate animals. 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.

B. Developmental Core

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 web site (http://www3.niaid.nih.gov/LabsAndResources/resources/cfar/interested/) and include it with the application.

C. Basic Science Cores

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.

D. Clinical Cores

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.

E. Scientific Working Groups

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 within the Scientific Working Group, and the establishment of successful collaborations within and between the Scientific Working Group and CFAR Cores. 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.

The Scientific Working Group should be of adequate size and scientific quality, should exhibit a high degree of interaction, encouraged to be multi-disciplinary, and should be capably led. To ensure adequate size and quality, a proposed Scientific Working Group must consist of a minimum of three independent Principal Investigators who are conducting three separate peer-reviewed and funded research projects in a related scientific area. Peer-reviewed, funded research sub-projects of larger Program grants (e.g., P01s) may be counted as separate projects.

It is possible that a Scientific Working Group may achieve its stated goals, such as acquiring funding from new sources or additional 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 initiated, 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:

• pulmonary complications of HIV infection
• collaborations to address human subject issues in international HIV/AIDS research
• collaborations to increase awareness of drug abuse complications in AIDS therapeutic, prevention, and behavioral studies
• scientific collaborations with investigators from diverse backgrounds
• collaborations to initiate or expand HIV/AIDS studies that address gender and race/ethnicity differences
• collaborations to initiate or expand efforts to develop, implement, and evaluate behavioral prevention interventions in clinical treatment settings
• comparative differences in molecular pathogenesis between HIV-positive and HIV-negative cancers
• well-designed studies to characterize and investigate traditional medicine or complementary and alternative medicine practices used in the treatment of HIV/AIDS
• sustainable interventions in resource-limited countries
• studies aimed at addressing the HIV and cancer crisis in resource-limited countries.

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 Working Group 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 by 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."

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide..

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

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 only as described in the NIH Grants Policy Statement.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review , NIH. Applications that are incomplete will not be reviewed.

Applications for supplements may are encouraged, depending upon funding availability. On an annual basis, NIH Institutes and Centers that co-fund CFARs may solicit for supplements to the CFAR grant for pilot projects in order to provide additional encouragement for new collaborative studies. In addition, the NIH CFAR Program and the Office of AIDS Research may solicit supplements for collaborative projects in areas identified by the NIH and NIH Advisory groups, together with suggestions from CFAR investigators. Both of these funding opportunities 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.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

The CFAR program provides administrative and shared research support to synergistically enhance and coordinate high quality HIV/AIDS research projects. CFARs accomplish this through core facilities that provide expertise, resources, and services not otherwise readily obtained through more traditional funding mechanisms. The CFAR program emphasizes the importance of interdisciplinary collaboration to promote translational research and encourages mentoring and training of young investigators.

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

Reviewers will consider each of the review criteria below in the determination of scientific 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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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? Will the CFAR enhance proposed scientific communication, outreach, training efforts, international collaborations, and collaborations with industry? Is there a high likelihood that the proposed D-CFAR will lead to development of a competitive standard CFAR application? Is there a significant need for coordination of HIV-related science at the institution, and will the CFAR serve as the primary coordinating unit for the institution(s)’s HIV-related science? Does the added value contribution of the CFAR go beyond what could be expected with the pre-existing HIV/AIDS research funding base?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the Center? 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? Do the proposed CFAR Director(s) have appropriate managerial experience, commitment, and leadership both in HIV/AIDS research and at the applicant institution(s)?

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?Within the CFAR structure is there sufficient diversity of topics across the disciplines involved in HIV/AIDS research projects, and are they fully committed to participation and coordination within the Center? Does the CFAR adequately describe innovative ways to integrate Cores, projects, technology, cohorts, trials etc using CFAR and other funds in order to achieve the scientific goals stated in the application?

For D-CFARS only, the following additional questions must be addressed. Are the proposed goals well matched to the available resources and will they foster future collaborative interactions? Is the proposed strategy for expanding the D-CFAR’s focus an innovative utilization of resources to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s)?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center 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? Does the annual strategic planning process adequately describe CFAR scientific and management plans? Are the policies and procedures for evaluating Cores, Scientific Working Group(s) and project(s), for reassigning funding priorities and for developing and utilizing outcome measurements, appropriate and do they reflect a high quality CFAR scientific planning and management process? Do the methods for selecting Basic and Clinical Core users and for prioritizing their use reflect a high quality CFAR scientific planning and management process? Is the management of the fiscal plan appropriate for the CFAR strategy? Are policies and procedures for obtaining assessments from HIV/AIDS investigators about the CFAR’s ability to meet their research needs adequate and appropriate?

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? Does the application provide sufficient evidence that the CFAR provides added value to HIV/AIDS research conducted at the institution? Is there adequate Institutional commitment, including space, financial support and other resources and oversight for CFAR activities? For renewals, is there a previous history of CFAR support for developmental projects and outcomes? Does the applicant institution have an appropriate history of translational research efforts? Are efforts towards community involvement and outreach adequately described and appropriate? Does the scientific environment at the CFAR effectively promote collaboration through Scientific Working Group(s)?

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed Center 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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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 on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

For Resubmissions, 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.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable.

As applicable for the Center proposed, reviewers will consider 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

Not Applicable.

Select Agent 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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

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

Significance

Does the core address an important problem or a critical barrier to progress in the field? If the aims of the core 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? 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?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the core? 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 core 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 core? Do the proposed Core Directors and key personnel have appropriate qualifications, competence and commitment?

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 core? Are potential problems, alternative strategies, and benchmarks for success presented? If the core is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the core 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? Does the Developmental Core's procedures effectively demonstrate function and effectiveness in selecting projects and performing outcome evaluations?

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 core proposed? Will the core benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the core proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed core 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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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 on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

For Resubmissions, 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 core.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable.

As applicable for the core proposed, reviewers will consider 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

Not Applicable.

Select Agent 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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

Reviewers will consider each of the review criteria below in the determination of scientific merit. 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 SWG address an important problem or a critical barrier to progress in the field? If the aims of the SWG 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? Will the proposed Scientific Working Group(s) and project(s) effectively enhance new multidisciplinary collaborations that may include international collaboration, collaboration with industry, or collaboration with junior or investigators from diverse backgrounds or investigators new to the HIV/AIDS field? Will the process for selecting and funding Scientific Working Group(s) and project(s) lead to independent funding of high-risk/high-impact studies? Do the Scientific Working Groups provide adequate evidence that the CFAR will provide significant capacity-building support for: junior faculty, investigators from diverse backgrounds, investigators from resource-limited settings, and new collaborations in HIV/AIDS, including CFAR-CFAR collaborations that would not be possible without the CFAR?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the SWG? 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 SWG 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 SWG?

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 SWG? Are potential problems, alternative strategies, and benchmarks for success presented? If the SWG is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the SWG 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 SWG proposed? Will the SWG benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the scientific environment at the CFAR effectively promote colaboration through SWGs?

As applicable for the SWG proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed SWG 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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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 on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

For Resubmissions, 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 SWG.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider 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

Not Applicable.

Select Agent 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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIAID (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Institute of Allergy and Infectious Diseases Advisory Council . The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• The extent to which the CFAR's activities would be coordinated with similar efforts by other organizations.
• The degree to which CFAR activities will add value to the HIV/AIDS research, provide economies of scale, and create synergy at the applicant institution(s)

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. . More information is provided at Award Conditions and Information for NIH Grants.

Not Applicable.

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.

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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

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.
Office of HIV and AIDS Malignancy
National Cancer Institute
Room 3135, MSC-2440
31 Center Drive
Bethesda, MD 20892-2440
Telephone: (301) 496-3204
FAX: (301) 480-4137
E-mail: domingug@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

NIA
Basil A. Eldadah, M.D., Ph.D.
Division of Geriatrics and Clinical Gerontology
National Institute on Aging
7201 Wisconsin Avenue
Gateway Building, Suite 3C-307, MSC-9205
Bethesda, MD 20892-9205
Telephone: (301) 496-6761
Fax: (301) 402-1784
E-mail: eldadahb@nia.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

NICHD
Susan F. Newcomer Ph.D.
Demographic and Behavioral Sciences Branch (DBS)
Eunice Kennedy Shriver Kennedy National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8B07G, MSC 7510
Bethesda, MD 20892-7510
(Rockville, Maryland 20852 for non USPS/courier service)
Telephone: 301-435 6981
Email: newcomes@mail.nih.gov

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

Deanna L. Ingersoll
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2110, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 451-2686
FAX: (301) 493-0597
Email: ingersolld@niaid.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 52 and 45 CFR Parts 74 and 92.