CENTERS FOR AIDS RESEARCH: D-CFAR, CFAR

RELEASE DATE:  March 27, 2003

PA NUMBER:  PAR-03-089 (This document has been reissued as PAR-06-291, 
see amendment, NOT-AI-05-036)

Receipt Date:  June 16, 2003, June 16, 2004, and June 16, 2005

EXPIRATION DATE:  June 17, 2005, unless reissued.

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

CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:

No. 93.213, Research and Training in Complementary and Alternative Medicine
No. 93.242, Mental Health Research Grants
No. 93.279, Drug Abuse Research Programs
No. 93.393, Cancer Cause and Prevention Research
No. 93.394, Cancer Detection and Diagnosis Research
No. 93.396, Cancer Biology Research
No. 93.839, Blood Diseases and Resources Research
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research
No. 93.864, Population Research
No. 93.865, Center for Research for Mothers and Children
No. 93.989, Senior International Fellowships

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Terms and Conditions of Award
o Required Federal Citations

PURPOSE OF THIS PA 

This program announcement replaces PAR-00-054 published in the NIH Guide, 
February 9, 2000.

Participating Institutes of the National Institutes of Health (NIH) invite 
applications for center core grants (P30) to support Centers for AIDS 
Research: standard CFARs (CFAR) and Developmental CFARs (D-CFAR).  CFAR cores 
provide infrastructure and promote basic, clinical, behavioral and 
translational AIDS research activities at institutions that receive 
significant AIDS funding from multiple NIH Institutes or Centers.  CFARs 
foster synergy and improve coordination of research, support emerging research 
opportunities, and promote economy of scale through resources shared by 
multiple independent laboratories.  CFARs and D-CFARs are intended to promote 
all AIDS research efforts at CFAR institutions.  D-CFARs provide modest 
support for a limited period to assist investigators in the development of a 
competitive CFAR.  Additionally, this announcement defines a process for CFAR 
competitive supplements.  Before preparing an application to support a CFAR, 
investigators are urged to consult with the program staff listed under 
"Inquiries."

NIH Support of Research on this Topic

While this Program Announcement is being issued by FIC, NCI, NCCAM, NHLBI, 
NIAID, NICHD, NIDA, and NIMH, the other components of NIH listed below also 
have an interest in and support research on the topics covered.  Applicants 
may wish to contact each of these NIH components listed in INQUIRIES to find 
out about other funding opportunities.  Institutes and Centers at NIH use 
different grant mechanisms to support their portfolios of research; the 
components listed here may not use all of the mechanisms specified for this 
Program Announcement.

National Center for Research Resources (NCRR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Applications submitted in response to Program Announcements are assigned 
according to established PHS referral guidelines.  When the subject of an 
application is of interest to more than one component of NIH, dual 
assignments are made.

DEFINITIONS

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

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, and eligible agencies of 
the Federal government. Racial/ethnic minority individuals, women, and persons 
with disabilities are encouraged to apply as principal investigators.

A.  Comparison of the two CFAR awards

This program announcement describes two types of CFAR awards.  The first is 
for a Developmental CFAR (D-CFAR) for 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 PA 
describes requirements for both types of CFARs.  Sections for the D-CFAR 
describe characteristics unique to this award.  

B.  NIH AIDS Funded Research Base

To be eligible for a CFAR award, an institution must have a significant 
research base.  A significant NIH AIDS funded research base (FRB) is defined 
as: the funding level, in annual total cost for the NIH fiscal year  (October 
1 to September 30), preceding receipt of CFAR applications.  The research base 
includes peer-reviewed AIDS grants, cooperative agreements, and research 
contracts utilizing only the following mechanisms:  P01, R01, R03, R18, R21, 
R24, R29, R33, R35, R37, U01, U10, U19, U24, U54, and K series awards, and N01 
(excluding contracts that primarily fund the production of materials or 
services for support of research). Excluded from the NIH AIDS Funded Research 
Base are all funds from any source other than NIH.  
For the D-CFAR and CFAR awards, a FRB in excess of $6 million is required.  
Below is a comparison table of the D-CFAR and CFAR awards.

                           D-CFAR                      CFAR

FRB/BASE FUNDING       >6M/$750K Total Cost      $6-40M/$1.5M Total Cost
                                                 $40-80M/$2.25M
                                                 >$80M/$3M
FUNDING PERIOD         3 years                   5 years
COMPETITIVE RENEWAL    Not allowed               Allowed
FOCUS                  Become competitive        Support all NIH AIDS
                       for a standard CFAR       investigators at institution

C.  Funds available 

D-CFAR: Maximum funding level, or base funding of a D-CFAR is limited to 
requests for 10% of the FRB as reported by the OAR spreadsheet for the NIH 
fiscal year preceding receipt of the application, up to $750,000 total cost.

CFAR: For institutions with a FRB of $6M to $40M, a CFAR award (Total Cost) 
will be limited to 10% of the FRB, up to $1.5M, total cost.  For institutions 
with a FRB of $40M to $80M, a CFAR award will be a base of $2.25M, total cost.  
For institutions with a FRB that is greater than $80M, a CFAR award will be a 
base of $3M total cost.

Recompeting CFARs will be limited to an inflationary increase beyond the total 
cost funding level of the current grant, unless the FRB decreases, in which 
case the following conditions apply:  If the FRB of a recompeting CFAR is 
below $15 million, the applicant is limited to requesting 10% of the FRB.  If 
the FRB of a recompeting CFAR is $15-40M, the applicant is limited to 
requesting $1.5M.  If the FRB of a recompeting CFAR is $40-80M, the applicant 
is limited to requesting a funding level of $2.25M.

CFARs that successfully recompeted for renewal in 2003, and that have a funded 
research base that is greater than $40M or greater than $80M, will be eligible 
to submit a complete revised proposal and budget request to increase the CFAR 
base funding to $2.25M total funds, and $3M total funds, respectively, for 
years 2 through 5 of the award.  This will be a one-time allowance in the 
first year of this program announcement.  Reviewers will evaluate the revised 
request as it relates to the recently funded program, but will not 
specifically review the recently funded program.  Should the new proposal not 
receive a fundable score, the CFAR will retain the existing budget until the 
entire CFAR submits a competitive renewal application.

D.  One CFAR award per institution

No institution will receive more than one CFAR award. Institutions that have 
significant overlap in faculty, resources or administration should submit only 
one application. Independent campuses that are part of a large, multiple city 
university are considered to be separate institutions.  Applicants are 
encouraged to contact program staff listed under "Inquiries" for additional 
guidance.  

E.  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.  Reviewers will look critically at the 
request for multi-institutional applications for the following indicators: a 
demonstration of exceptional need to establish a collaboration between 
investigators at separate 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 anticipated budgetary problems in 
the transfer of funds and resources from one institution to another; and 
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.  CFARs that use a 
distant institution for a core facility, but are not including all of the NIH 
AIDS investigators at that institution as part of the CFAR may not use the 
Funded Research Base of any single investigator at that institution. 

A CFAR cannot use the FRB of an institution that is already part of another 
CFAR.

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. 

F.  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).

G.  Funding for CFARs from multiple NIH Institutes

CFARs will be awarded and administered by 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 'Inquires' to 
discuss general CFAR issues, and how CFARs can enhance the AIDS research 
mission of the NIH Institutes.

H.  CFAR support for all NIH AIDS investigators

NIH will provide applicants with a spreadsheet (Excel) prepared by the Office 
of AIDS Research (OAR) indicating all investigators receiving NIH AIDS funding 
at an applicant(s) institution, arranged by NIH funding Institute.  Applicants 
should indicate, in the spreadsheet, those investigators who have formally 
agreed to participate in the CFAR, and the primary type of participation 
expected (e.g., attendance at seminars, use of virology core, Developmental 
Core director, etc.) and include this spreadsheet in their application.  See 
section E, Administrative Core, for more detail on CFAR support of all 
investigators.

It is important that the CFAR be inclusive of the full range of AIDS science 
funded at a given institution.  Therefore, review committees will be 
interested in why some investigators listed in the spreadsheet chose 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.

RESEARCH OBJECTIVES - ALL CFAR AWARDS

Note that the following applies to all types of CFAR awards.  Following this 
section is information concerning research objectives that are specific for 
the D-CFAR.

Background

The CFAR program was established in 1988 and was renewed in 1993, 1997, and 
2000. In May 1999, an ad hoc external review committee convened by the Office 
of AIDS Research reviewed the CFAR program.  Suggestions of the review 
committee remain incorporated into this program announcement.  The mission of 
the CFAR program and mechanisms for achieving this mission were developed by 
the CFAR directors in 1995 and revised in 1996, 1998, and in the 2002 Position 
Statement of the NIH CFAR Directors. 

The mission of the CFARs is to support a multi-disciplinary environment that 
promotes basic, clinical, epidemiological, behavioral, and translational 
research in the prevention, detection, and treatment of HIV infection and 
AIDS. The CFARs accomplish this mission by:

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

A.  CFAR added value

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

Measures of added value include, but are not limited to: Developmental Core 
awards resulting in collaborations, publications, or funding of R01-type 
applications; interdisciplinary publications; evidence of CFAR enhancement of 
existing programs at the institution; the number of clinical protocols started 
within the institution; patent applications filed or issued; and institutional 
support for activities previously supported by the CFAR.  For recompeting 
CFARs, Table (2) is provided on the CFAR web site  
(http://www.niaid.nih.gov/research/cfar/cfarpa.htm), and should be used by the 
applicant to demonstrate various translational research activities.  The 
activities shown as examples are not meant to be all-inclusive. 

B.  CFARs should serve the requirements of all NIH-funded AIDS investigators 
at the applicant institutions 

Cores should address the needs of AIDS investigators at the applicant 
institution(s). Successful CFARs have accomplished this goal.  Applicants 
should describe in detail the operation of each core (quality control, 
procedures, safety, training, etc.) and how the proposed policies and 
procedures protect and incorporate the divergent needs of CFAR investigators.  
Please see additional details concerning policies and procedures under 
"Administrative Core".  Applicants are encouraged to contact program staff 
listed under "Inquiries" to discuss strategies being planned for how the CFAR 
will foster collaboration among AIDS investigators from divergent disciplines.  
Applicants for recompeting CFARs should describe how different NIH-funded AIDS 
programs, if funded at the institution, participate in the CFAR.  Specific 
programs funded by the co-funding institutes are listed under "Administrative 
Core".

C.  CFARs have scientific and fiscal flexibility

A CFAR has the responsibility to use its resources in the best manner to meet 
the needs of its investigators.  A CFAR has the authority to change allocation 
of resources according to the guidelines of CFAR operating policies and 
procedures.  Applicants should describe how proposed policies and procedures 
provide structure for decision-making on several levels, and how each of the 
following individuals or groups would participate in the decision process: 
core director, CFAR director, internal advisory board, CFAR investigators, and 
external advisory board.  Applicants should also state the process for 
informing NIH of major changes in the CFAR.

A CFAR has considerable flexibility and authority to alter funding of a basic 
or Clinical Core, to delete a core, or to initiate a new core.  Applicants 
should state what policies and procedures will be used as the basis for 
reallocation of initial core funding to permit the establishment of new cores, 
as needed, without additional funding.

The extent to which CFAR funding may leverage other resources in support of 
AIDS research is an important measure of a CFAR's value to 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 necessary 
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., a 
NIAID AIDS Clinical Trial Unit or an NCI Cancer Center core facility) may 
become more accessible to AIDS investigators through CFAR association and 
coordination.  Commitments for continued funding in the non-competitive 
continuation years of all NIH grants are dependent upon the availability of 
funds. Applicants should describe policies and procedures for CFAR "down-
sizing" decisions if there is decreased funding for continuation years.

Responsible management includes annual reporting of progress.  The NIH has 
developed guidelines that specify the kind of information it needs in order to 
answer questions about the program that come from various constituencies, 
including Congress.  The NIH will assess previous progress reports submitted 
by recompeting applicants, as well as additional responses to requests for 
information.  Results of this assessment will be made available to the 
applicant and to reviewers of the competitive renewal. Assessments will 
reflect general trends during the funding period, rather than a single 
outstanding or insufficient response.

D.  Additional CFAR-supported activities 

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

Applicants are encouraged to explore collaborative, multi-institutional 
linkages with international sites and minority institutions.  Such linkages 
foster international 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 Center is 
strongly encouraged.  Contact information for Fogarty programs is provided 
under "Inquiries".

Examples of ways in which current CFARs are able to assist in the development 
of new investigators, including junior faculty and minority investigators, 
both domestic and international, are as follows.  These examples are not meant 
to be all-inclusive.

1.  Specific mentoring programs for junior faculty that may include guidance 
in the preparation of developmental core applications, and additional follow-
up counseling if the initial application is not funded.

2.  Establishment of collaborations between investigators at institutions in 
the developing world that might include mini-sabbaticals to the CFAR to 
utilize core facilities, and the mentoring of investigators at the distant 
site in person, or via computer linkages.

3.  Developing specific collaborations with other NIH programs such as the 
AIDS International Training and Research Program (AITRP) with the Fogarty 
International Center or the Research Centers in Minority Institutions (RCMI) 
program with the National Center for Research Resources (NCRR).

E.  CFAR awards support four different types of cores: administrative, 
developmental, basic science, and clinical studies:  

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

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

1.  Administrative Core

The Administrative Core is responsible for the management of all CFAR 
activities. The Administrative Core is led by a CFAR director (P30 grant's 
Principal Investigator) who should be a recognized leader in the field of AIDS 
research.  The Administrative Core also may require a senior administrator, a 
CFAR office, and a modest staff for support of CFAR activities. The 
responsibilities and time allocation of each staff person and the proposed 
operational procedures for the Administrative Core should be described in 
detail.  

The Administrative Core section of the CFAR application should contain 
separate sections describing the strategic plan, and policies and procedures.  
Both of these sections will be incorporated by reference into the Terms and 
Conditions of Award.  

a) Strategic plan – Successful applicants will be required to carry out and 
report on an ANNUAL strategic planning process to assess current and expected 
scientific and fiscal needs and planned adjustments, according to the stated 
policies and procedures.
 
The purpose of the strategic plan is to identify the most significant 
opportunities and gaps in science at the applicant institution to be addressed 
by the CFAR in the short and long term, and to identify objective milestones 
that can measure success or failure.  The following process and organization 
is suggested for the strategic plan:

1) Strengths - Describe the strengths of the CFAR including a summary of 
research of CFAR participants and the current facilities and resources 
available.  Use Table 4, "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://www.niaid.nih.gov/research/cfar/cfarpa.htm).  
Use the column labeled "Participating" in the Excel table showing the NIH AIDS 
Funded Research Base of the institution(s) to indicate investigators who will, 
and will not, be participating in the CFAR.  Provide a brief explanatory 
sentence at the bottom of the table for any non-participating.  Recompeting 
applicants should describe how any major AIDS programs at the CFAR 
institution that are supported by co-funding NIH Institutes are assisted by 
CFAR.  Specific programs are:
 
FIC: AITRP, AIDS FIRCA, ICHORTA-AIDS/TB, and GHRIP
NCI: AMC, ACSB
NHLBI: CBR
NICHD: WHIN, Ad health, REACH
NIDA: DARC
NIAID: AACTG,  PACTG, HPTN, HVTN, CIPRA, IPCP,  MACS, WIHS
NIMH: Brain Bank, EBAN

2) Opportunities - Identify and evaluate all potential opportunities for use 
of CFAR funds. This analysis will probably require outreach for suggestions 
from all potential CFAR participants. Conduct a cost/benefit analysis to 
determine which opportunities both utilize the applicant's unique strengths 
and address the missions of NIH funding Institutes.

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

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

In addition to other items, place information about any advisory committees 
under the Administrative Core.  Describe the membership of all committees, the 
basis for selection of participants, and terms of appointment, authority and 
responsibility.

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

b) 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.

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

o  the proposed roles of the CFAR director, core directors, CFAR 
investigators, advisory boards, and institutional officials in the decision-
making process.

o  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 
authority and responsibility of internal and external advisory committees; how 
developmental projects are selected and evaluated; how cores are selected and 
reports are developed, including the annual strategic plan and the 
noncompetitive renewal.

o  other mechanisms used to determine AIDS basic and clinical research core 
needs at the applicant institution(s), assign priorities to potential cores, 
and select the basic and Clinical Cores to be included in the application.

2.  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: investigators new to AIDS research who have not previously 
received R01-type awards in AIDS research, feasibility studies, emerging 
research opportunities, and AIDS research activities of newly recruited 
faculty.  Applicants are encouraged to explore the use of the Developmental 
Core to fund a collaborative study that encompasses two scientific 
disciplines, especially two that may not have previously collaborated (e.g., 
basic scientists and scientists studying complementary and alternative 
medicine, such as chiropractic or acupuncture; or behavioral scientists and 
population geneticists).  Examples provided are not meant to be all-inclusive.  
Applicants may wish to consult with program staff listed under "Inquiries" to 
discuss how Developmental Cores are used at current CFARs.  

The CFAR Administrative Core should establish the mechanisms for allocation of 
developmental funds and for annual evaluation of supported activities. CFAR 
applicants should describe the mechanism to be used for identification, peer-
review selection, and outcome evaluation of projects supported by the 
Developmental Core.  The Developmental Core director is responsible for 
ensuring that all developmental studies involving human or animal subjects 
have the appropriate approvals (i.e., domestic and foreign IRB, FWA, IACUC, 
human subjects research training, etc.).  Applicants must inform the NIH of 
any awards made for developmental studies involving foreign sites as soon as 
possible.  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 
table provided for this purpose on the CFAR program announcement web site 
(http://www.niaid.nih.gov/research/cfar/cfarpa.htm) and include with the 
application (Table 3). 

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

3.  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.   
Reviewers will look for an emphasis on well managed and efficient core 
functions above the overall number and breadth of cores in a given 
application.  Please use Table 4 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 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, evaluate use annually, and justify level of continued 
CFAR support in the context of evolving scientific priorities at the applicant 
institution(s).

4.  Clinical Cores

Clinical Cores should have a clear focus and provide the resources for AIDS 
translational research between collaborating clinical and basic scientists.  
The primary distinction between a Basic and Clinical Core is that a Clinical 
Core has direct interaction with patients.  This may involve developing a 
database for clinical specimens, an intervention for a behavioral study, or 
development of INDs.  Activities that will not be supported by a CFAR Clinical 
Core are normal patient care, including screening of clinical specimens, 
diagnosis, treatment or rehabilitation.

Applicants are reminded of the Form 398 requirement to address the 
involvement of human subjects and vertebrate animals 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 or vertebrate animals should provide full Human Subjects 
Research and Vertebrate Animals Research sections as per Form 398 
instructions.

Mechanisms should be described to prioritize core usage, evaluate use 
annually, and justify level of continued CFAR support in the context of 
evolving scientific priorities at the applicant institution(s).

F.  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.  Examples of the types of 
institutional commitment that are demonstrated by current CFARs are: level of 
institutional funding, space allocation, co-funding, endowments, designation 
of center program status in the institutional bylaws, and provision of a 
waiver or partial waiver for indirect costs for certain components of the 
CFAR, such as funding of the Developmental Core.  These are examples, and are 
not exclusive of other possible ways in which an institution may demonstrate 
support for the CFAR.  The applicant must provide a letter(s) from the 
appropriate institutional official(s) (e.g., Dean, President, or Provost) 
defining:

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

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

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

G.  Scientific Programs and Competitive Supplements

In order to take full advantage of the ability of CFARs to organize AIDS 
research at an institution, to encourage collaboration between scientific 
disciplines and diverse areas of expertise, and to explore significant 
questions and problems in AIDS that are not being addressed, a CFAR is 
encouraged, but not required, to identify one, or several, Scientific 
Programs.  A Scientific Program is defined as an area of scientific activity 
for a group of investigators who share common research interests and goals 
and participate in competitively funded research.  Scientific Programs 
function to encourage an existing research direction or a new scientific 
focus.  Examples of possible Scientific Programs include, but are not limited 
to: HIV/AIDS Vaccine Development, HIV/AIDS Prevention, and HIV/AIDS Treatment.  
The examples provided are meant to be broad enough to include diverse 
biomedical disciplines, e.g., behavioral change, epidemiology, pathogenesis, 
clinical research, etc.

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

There are three possible ways to fund new collaborative projects: (1) through 
new R01 or P01 applications; (2) with CFAR base funding through the 
Developmental Core; (3) through competitive supplements.  The first is self-
explanatory, and the second and third are explained in more detail below.

CFARs and the Scientific Director 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.  Projects may be submitted to the NIH as R01 or P01 
applications, or may be funded through the Developmental Core of the CFAR.  
Examples of scientific projects are provided to suggest a variety of 
collaborations that could be considered, but are not limited to those that are 
listed: Pulmonary Complications of HIV Infection, Collaborations to Address 
Human Subject Issues in International AIDS Research, Collaborations to 
Increase Awareness of Drug-Abuse Complications in AIDS Therapeutic, Vaccine, 
and Behavioral Studies, Scientific Collaborations with Minority Investigators, 
Collaborations to Initiate or Expand AIDS Studies that Address Gender 
Differences, Collaborations to Initiate or Expand Efforts to Develop and 
Implement Behavioral Prevention Interventions in Clinical Treatment Settings, 
Interdisciplinary Collaborative Studies Investigating the Interplay between 
Cancer Pathogenesis, Virus Infections and HIV Induced Immune Suppression, 
Well-designed Studies to Characterize and investigate Traditional Medicine or 
Complementary and Alternative Medicine Practices Used in the Treatment of 
HIV/AIDS, and Sustainable Interventions in Developing Countries.

To provide additional encouragement for new collaborative studies, the NIH 
may accept requests on an annual basis for competitive supplements for 
scientific projects.  An NIH Institute participating in the co-funding of the 
Program may solicit requests for competitive supplements to launch scientific 
programs in a specific area of AIDS research in line with the mission of that 
Institute.  In addition, the NIH CFAR Program, and the Office of AIDS 
Research, will provide competitive supplements for collaborative projects in 
areas identified by the NIH, and NIH Advisory groups, with suggestions from 
CFAR investigators.  Both of these funding mechanisms are subject to funding 
availability each year; and funding opportunities, if available, will be 
announced each year in early January on the NIH CFAR web site, or by email 
communication to eligible investigators.

Funding of the Scientific Director position(s) can be requested for 
development of a scientific program(s) through the Administrative Core.  
Funding for collaborative projects will be through the Developmental Core, 
either from base CFAR funds, or through a competitive supplement.  At the time 
of submission of a competitive renewal application, applicants should identify 
a scientific director(s), the scientific program(s), and specific plans that 
will be used to develop collaborative activities.  In addition, procedures for 
identifying projects, reviewing project applications, and choosing projects to 
be supported, should be clearly identified.  Policies for continuing, 
terminating/revising, or rebudgeting funds for a project should be clearly 
identified in the event that the project director leaves the institution, the 
study achieves an earlier endpoint than expected, or other unexpected data or 
results becomes available that suggests a change in focus.  These policies 
will be evaluated by the reviewers to determine the ability of the applicant 
to responsibly manage funds for these projects during the CFAR funding period, 
and will be incorporated into the terms and conditions of award if the CFAR 
application is successful.  Only CFARs that have been funded for one year or 
longer are eligible to utilize base CFAR funds or receive competitive 
supplements for funding of these scientific programs and collaborative 
projects.

As described under "Funds Available," CFARs that successfully recompeted for 
renewal in 2003, and that have a funded research base that is greater than 
$40M or greater than $80M, will be eligible to submit a revised proposal and 
budget request to increase the CFAR base funding.  If a CFAR chooses to submit 
a revised proposal, it may also respond to the scientific collaboration 
component of the program at the same time.  The CFAR would need to respond to 
competitive supplement initiatives separately from the revised proposal.

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.  At the Annual 
CFAR Directors' Meeting, investigators will be required to present a status 
report and to describe future plans for ongoing collaborative projects.

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

CFAR BUDGET ITEMS

A.  Percent Effort

The percent effort requested should be limited to time devoted specifically to 
managing CFAR activities and not to research.  The effort devoted to CFAR 
activities should not be that which would normally be supported by 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 percent 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) should be requested for the CFAR office only for 
matters directly pertaining to the CFAR. 

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 R01-type grants are expected to have 
salary support from other sources.  

B.  Core Budgets

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

C.  Other Administrative Costs

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

D.  Travel

CFAR Directors' Meeting(s) — The CFAR Director is required to attend the 
Annual Directors' Meeting.  The CFAR director, the CFAR administrator, and one 
senior scientist per center may be provided support to meet at least once, and 
possibly two times per 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.  For budget purposes applicants may assume 
a total annual direct cost of $6,500 for the CFAR Directors' Meeting(s).

Other Travel — Applicants may request and justify travel funds in addition to 
the funds required for the two directors' meetings.  These funds should not be 
used for travel to scientific meetings, nor should they be used for 
advertising and promotion.  They may be used for travel to meet with 
collaborators at foreign sites.  For example, this travel could be used to 
promote collaboration among CFAR investigators and AIDS investigators not in 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 or developing world investigators at CFAR-sponsored meetings and 
workshops.  These additional travel funds should not exceed $20,000 annual 
direct costs.

DEVELOPMENTAL CFARs (D-CFAR)

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

All eligibility requirements and specific descriptions provided in this PA for 
the CFAR awards are also required for and relevant to, the D-CFAR awards.  The 
minimum number and type of cores for a D-CFAR is the same as for a standard 
CFAR: one administrative, one developmental, one basic and one clinical.  
There are several differences between a D-CFAR and a S-CFAR. The maximum 
funding level for the D-CFAR award is $750,000 and it is a one-time award for 
3 years.  We encourage independent AIDS investigators interested in expanding 
collaborative efforts at their institution to consider applying for this 
award.

Applicants who have never received a CFAR award are eligible to apply, as are 
previous CFAR applicants who have not been successful in recompeting for the 
CFAR award.  Applicants who have not received a CFAR award may choose to apply 
for either a standard or developmental CFAR award.  Because the D-CFAR is 
designed to assist the applicant in the organization and development of a 
competitive CFAR application, reviewers will look very carefully at previous 
CFAR applications from the same applicant regarding the feasibility of 
overcoming obstacles identified by previous reviewers.  Applicants should 
clearly indicate in the title of the application and in the abstract that this 
is for the D-CFAR award.  If no indication is provided it will be assumed that 
the application is for a standard CFAR.

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 Core for CFARs, above.  The strategic plan should provide 
sufficient detail about procedures that will be used to identify challenges at 
the institution and proposed solutions that would lead to development of a 
competitive CFAR application within the three-year funding period.  Proposed 
outcome measurements for strategies, and core facilities selected for year 1 
should be clearly explained, as well as procedures for adjusting the plan for 
years 2 and 3, should changes be needed.

Like the standard CFAR award, the D-CFAR provides funding to foster synergy 
and improve coordination of research, support emerging research opportunities, 
and promote economy of scale through resources shared by multiple independent 
laboratories.  D-CFARs also encourage other activities that serve the 
requirements of AIDS research.  See 'Additional CFAR supported activities'.  
Any of these activities may be fostered through a D-CFAR award.

Because both the funding period and level are less than that for a CFAR award, 
the D-CFAR is not expected to propose all core facilities that would be 
proposed for a standard CFAR.  The emphasis for D-CFAR is on the 
identification of gaps or deficiencies that would hinder development of a 
competitive CFAR application, and core facilities that will reduce or 
eliminate these gaps. 

MECHANISM OF SUPPORT

This PA will use the NIH center core grant (P30) award mechanism.  The 
applicant will be solely responsible for planning, directing, and executing 
the proposed project.  The total project period for CFAR grants may not exceed 
five years, and applicants are encouraged to apply for five years.  For
D-CFARs the total requested project period may not exceed three years.  

APPLICATIONS IN RESPONSE TO THIS PA MUST BE PREPARED USING A MULTI-PROJECT 
GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR PREPARING THE CFAR 
APPLICATION CAN BE FOUND AT THE CFAR WEBSITE: 
http://www.niaid.nih.gov/research/cfar/cfarpa.htm

ELIGIBLE INSTITUTIONS 

Domestic institutions may submit an application if the institution has any of 
the following characteristics:

o  For-profit or non-profit organization 
o  Public or private institutions, such a university, college, hospital, and 
laboratory 
o  Units of State or local government

Foreign institutions are not eligible to apply.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.  The principal investigator should be a 
recognized leader in the field of AIDS research.

SPECIAL REQUIREMENTS 
 
When clinical studies or trials are a component of the research proposed, 
NIAID policy requires that studies be monitored commensurate with the degree 
of potential risk to study subjects and the complexity of the study.  Terms 
and Conditions of Award will be included with awards.  NIAID policy was 
announced in the NIH Guide on February 24, 2000 and is available at: 
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html.  The full 
policy, including terms and conditions of award, is available at: 
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Please check the following 
website for any changes in contact information:  
http://www.niaid.nih.gov/research/cfar/cfarpa.htm.  Inquiries may fall into 
three areas:  scientific/research, peer review, and financial or grants 
management issues:

o Direct questions about scientific/research issues to:

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

Janet M. Young, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases 
Room 4137, MSC-7626
6700-B Rockledge Drive
Bethesda, MD 20892-7626 
Telephone: (301) 496-6714
FAX: (301) 402-3211 
Email: jy6r@nih.gov 

For questions regarding D-CFAR and CFAR scientific and program interests of 
other Institutes and 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: jm548f@nih.gov

NCI

Jodi B. Black, Ph.D.
AIDS Malignancy Program
National Cancer Institute
Room 3A44, MSC-2440
31 Center Drive
Bethesda, MD 20892-2440
Telephone: (301) 402-6293 
FAX : (301) 496-0826 
Email: jb377x@nih.gov

NCCAM

Morgan N. Jackson, M.D., M.P.H.
Division of Extramural Research and Training 
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475 
Bethesda, MD 20817 (use for express/courier service)
Telephone: (301) 402-1278
FAX: (301) 480-3621
email: mj145m@nih.gov

NHLBI

Elaine Sloand, M.D.
Office of the Director
National Heart, Lung and Blood Institute
Room 4A11, MSC 2490
31 Center Drive 
Bethesda, MD  20892-2490
Telephone: (301) 496-3245
FAX: (301) 594-1290
E-mail: es38n@nih.gov 

NICHD

Pat Reichelderfer, Ph.D.
Contraception and Reproductive Evaluation Branch
National Institute of Child Health and Development
Room 8B13
6100 Executive Boulevard
Rockville, MD  20852
Telephone: (301) 496-1661
FAX: (301) 480-1972
E-mail: pr20f@nih.gov 

NIDA

Jag Khalsa, Ph.D.
Center on AIDS & Other Medical Consequences
National Institute on Drug Abuse
Room 5198, MSC 9593
6001 Executive Blvd.
Bethesda, MD 20892-9593
Telephone: (301) 443-1801
FAX: (301) 594-6556 or 443-4100
Email:  jk98p@nih.gov

NIMH

Dianne Rausch, Ph.D.
Center for Mental Health Research on AIDS
National Institute of Mental Health
Room 6209, MSC 9619
6001 Executive Blvd.
Bethesda, MD  20892-9619
Telephone: (301) 443-7281
FAX: (301) 443-9719
E-mail: dr89b@nih.gov 

o Direct questions about peer review issues to:

Dianne Tingley, Ph.D.
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases 
Room 2148, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 
Telephone: (301) 496-2550
FAX: (301) 402-2638 
Email: dt15g@nih.gov 

o Direct questions about financial or grants management matters to:

Lori Zimand
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases 
Room 2246, MSC-7614 
6700-B Rockledge Drive
Bethesda, MD 20892-7614 
Telephone: (301) 451-4580 
FAX: (301) 493-0597 
Email: lz36k@nih.gov 

SUBMITTING AN APPLICATION

Applicants for P30 grants must follow special application guidelines in the 
NIAID Brochure entitled SPECIAL INSTRUCTIONS FOR PREPARATION OF THE CFAR 
APPLICATION; this brochure is available via the WWW at: 
http://www.niaid.nih.gov/research/cfar/cfarpa.htm

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted on the dates indicated on the front page of 
this document.

Applications that are not received as a single package on the receipt date or 
that do not conform to the instructions contained in PHS 398 (rev. 5/01) 
Application Kit (as modified in, and superseded by, the NIAID BROCHURE 
ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS") will be 
judged non-responsive and will be returned to the applicant.  

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:  
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as applicant is developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept the application 
for consideration for award; and,
  
3)  Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. The 350-page limit also applies to 
these applications. Additional information on this policy is available in the 
NIH Guide for Grants and Contracts, October 19, 2001 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

For applications in response to this program announcement, the page limitation 
is 350 pages for the research plan of the CFAR or D-CFAR application, 
excluding appendices, required tables 
(http://www.niaid.nih.gov/research/cfar/cfarpa.htm), Bio-sketches, and Other 
Support, literature cited sections, and other sections that normally fall 
outside of sections A-D of the research plan.  Please note that appendices 
are provided only to the reviewers assigned to the application, and not to all 
reviewers.  Appendices should not contain information required for review by 
other committee members, and are limited to 10 documents or 100 pages.  The 
350-page limit is a maximum, and applicants are encouraged to be concise.  
Applicants submitting a revised application may include an additional 30 pages 
to discuss the response to the reviewers' comments.  It is helpful to the 
review committee if these are placed at the beginning of the research plan, 
with reference to locations in the application where changes can be found.  
Other support should not be provided in the initial application submission.

SPREADSHEETS AND TABLES

NIH will provide applicants with a spreadsheet (Excel) indicating all 
investigators receiving NIH AIDS funding at an applicant's institution (or 
institutions if a multi-institution application), arranged by NIH Institute.  
Applicants should indicate in the "Participating" field provided, those 
investigators who have formally agreed to participate in the CFAR, and a brief 
explanation at the bottom of the table as to why investigators may not be 
participating.  Indicate the type of participation, i.e., core director, user 
of Virology Core, etc.

The NIH will provide tables in MSWord for additional information required of 
both new and recompeting applications.  These may be found at the CFAR program 
announcement website: http://www.niaid.nih.gov/research/cfar/cfarpa.htm 

SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD  20817 (for express/courier service)

Two single-sided copies of the application (text) and five copies of 
appendices must be sent to: 

Dianne Tingley, Ph.D.
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases 
Room 2148, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616   
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: the receipt dates described on the first page of this 
document must be followed.  The CSR will not accept any application in 
response to this PA that is essentially the same as one currently pending 
initial review unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of a substantial 
revision of an application already reviewed, but such application must 
include an Introduction addressing the previous critique.

Concurrent submission of an R01 and a Component Project of a Multi-project 
Application:  Current NIH policy permits a component research project of a 
multi-project grant application to be concurrently submitted as a traditional 
individual research project (R01) application.  If, following review, both 
the multi-project application and the R01 application are found to be in the 
fundable range, the investigator must relinquish the R01 and will not have 
the option to withdraw from the multi-project grant.  This is an NIH policy 
intended to preserve the scientific integrity of a multi-project grant, which 
may be seriously compromised if a strong component project(s) is removed from 
the program.  Investigators wishing to participate in a multi-project grant 
must be aware of this policy before making a commitment to the Principal 
Investigator and awarding institution.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the NIH 
Center for Scientific Review and for responsiveness to the goals of this PA 
by NIAID staff in consultation with the other co-funding Institutes.  
Incomplete or non-responsive applications will be returned to the applicant 
without further consideration.  

Applications submitted for this PA will be assigned on the basis of established 
PHS referral guidelines.  P30 applications that are complete and responsive
to this PA will be evaluated for scientific and technical merit by an 
appropriate peer review group convened by the NIAID.

As part of the initial merit review, all applications will:

o  Receive a written critique
o  Be assigned a priority score
o  Receive a second level review by the National Allergy and Infectious 
Diseases Advisory Council and the appropriate Councils or Boards of the co-
funding Institutes 

REVIEW CRITERIA

In addition, the following review criteria specific to this PA will be used 
in evaluation of applications.  Review criteria are based on the mission of 
the CFAR Program and mechanisms for achieving this mission.  The initial 
review group (IRG) will evaluate D-CFAR, and CFAR applications for 
significance, approach, innovation, investigator, and environment.  In these 
evaluations, the IRG will also look for evidence of successful performance 
from applicants that have had CFAR awards or similar programs at their 
institutions.

The organizational structure of sections in a CFAR application resembles that 
of an R01 application:

CFAR Application                                -R01 Application 
-Strengths                                      -Background
-Opportunities                                  -Significance
-Action Plan and Outcome Measurements           -Specific Aims
-Policies and Procedures                        -Materials & Methods
-Choice of Cores and their                      -Preliminary Results
  Operating Structures                            for new applications
-Progress Report for                            -Progress Report for
  renewal applications                            renewal applications

The NIH review criteria have been adapted to ensure that the major components 
of a CFAR application are evaluated appropriately.  The score should reflect 
the overall impact that the project could have on the field based on 
consideration of the five criteria, with the emphasis on each criterion 
varying from one application to another, depending on the nature of the 
application and its relative strengths.  Note that an application need not be 
strong in all categories to be judged likely to have major scientific impact 
and thus deserve an outstanding priority score.  For example, an investigator 
may propose to carry out important work that by its nature is not innovative 
but is essential to move a field forward.  Review criteria are listed 
separately for the developmental CFAR (D-CFAR), the standard CFAR (CFAR), 
awards.

REVIEW CRITERIA FOR D-CFARS

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

1.  Evidence that the proposal will lead to development of a competitive 
standard CFAR application
2.  The ability of Cores to support the research base, foster synergy, 
enhance AIDS research collaborations and produce an economy of scale
3.  The ability of proposed scientific communication, outreach, training 
efforts, international collaborations, and collaborations with industry to 
assist AIDS investigators and lead to development of a competitive CFAR 
application
4.  Developmental Core procedures for selection of projects and outcomes 
evaluation

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

5.  Annual strategic planning process
6.  Policy and procedures to judge value of Cores and reassign funding 
priorities; outcome measurements
7.  Methods for selection of Basic and Clinical Core users and for 
prioritization of use
8.  Policies and procedures to identify gaps and mechanisms for filling them

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

9.  The degree of variety in AIDS research projects and disciplines that 
commit to participation in and coordination through the D-CFAR structure 
10.  The incorporation into the D-CFAR of resources (Cores, projects, cohorts, 
trials, etc.) that are supported in part or not at all by D-CFAR funds
11.  Resources available to enhance a particular D-CFAR goal in order to 
facilitate future collaborative interactions

Investigator – The choice of appropriate leaders to carry out the D-CFAR  
mission

12.  Choice of D-CFAR director, e.g., managerial experience, commitment, 
leadership in AIDS research and at the applicant institution
13.  Choice of core directors and key personnel, e.g., qualifications, 
competence and commitment
14.  Proposed advisory groups: responsibility, methods for their selection, 
and contribution to the overall D-CFAR goals

Environment – The likelihood that a D-CFAR will achieve its objectives

15.  Evidence for D-CFAR providing value added to the AIDS research at the 
institution
16.  Institutional commitment including space, institutional financial support 
and other institutional resources and oversight provided for D-CFAR activities
17.  Appropriateness of budget of the overall D-CFAR and of the individual 
cores
18.  Proposed strategy for expanding the D-CFAR focus

REVIEW CRITERIA FOR CFARS

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

1. The ability of Cores to support the research base, foster synergy, enhance 
AIDS research collaborations and produce an economy of scale
2. Evidence that CFAR will enhance proposed scientific communication, 
outreach, training efforts international collaborations, and collaborations 
with industry
3. Developmental Core procedures for selection of projects and outcomes 
evaluation

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

4.  Annual strategic planning process
5.  Policy and procedures to judge value of cores and reassign funding 
priorities; outcome measurements
6.  Methods for selection of basic and Clinical Core users and for 
prioritization of use

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

7.  The degree of variety in AIDS research projects and disciplines that 
commit to participation in and coordination through the CFAR structure 
8.  The incorporation into the CFAR of resources (Cores, projects, cohorts, 
trials, etc.) that are supported in part or not at all by CFAR funds

Investigator – The choice of appropriate leaders to carry out the CFAR 
mission

9.  Choice of CFAR Director, e.g., managerial experience, commitment, 
leadership in AIDS research and at the applicant institution
10. Choice of Core directors and key personnel, e.g., qualifications, 
competence and commitment
11. Proposed advisory groups: their responsibility and methods for membership 
selection

Environment – The likelihood that a CFAR will achieve its objectives  

12. Evidence for CFAR providing value added to AIDS research at the 
institution
13. Institutional commitment including space, institutional financial support 
and other institutional resources and oversight provided for CFAR activities
14. Previous history of CFAR support for developmental projects and outcomes
15. Previous history of translational research efforts
16. Appropriateness of budget for the CFAR overall and of the individual 
Cores

REVIEW CRITERIA FOR SCIENTIFIC COLLABORATIONS

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

1. Evidence for innovative, high-risk/high-impact project(s) that will 
address significant problems or gaps in the AIDS field that cannot be 
addressed easily through other funding mechanisms
2. Evidence that the proposed project(s) will enhance new multidisciplinary 
collaborations, that may include international collaboration, collaboration 
with industry, or collaboration with junior or minority investigators
3. Evidence that the process for selection of projects to be funded will lead 
to independent funding of high-risk/high-impact studies

Approach - The quality of the CFAR scientific projects, including planning 
and management process

4. Project design and appropriate Core selection
5. Policy and procedures to identify and select scientific projects, reassign 
funding priorities, and to measure outcome of projects 

Innovation – The identification of a unique project or approach to solve an 
significant question or gap in AIDS research

6. The degree of variety in AIDS scientific disciplines that are included in 
proposed scientific projects
7. The degree of innovation in project selection and experimental design

Investigator – Choice of appropriate scientists to lead the identification and 
development of collaborative projects

8. Choice of Scientific Director for scientific areas proposed: leadership in 
the field of AIDS 
9. Choice of project leader for individual collaborative projects proposed: 
scientific qualifications, commitment

Environment

10. Availability of appropriate scientific expertise
11. Previous history of support for developmental projects and outcomes 
12. Appropriateness of budget for the scientific projects and of the 
individual Cores
13. Evidence that scientific collaborative areas and projects arise from the 
scientific environment at the CFAR institution(s)

ADDITIONAL REVIEW CRITERIA:  In addition, the following review criteria items 
will be considered in the determination of scientific merit and the priority 
score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data.

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

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

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

CONDITIONS OF AWARD

The Conditions of Award will incorporate the following items proposed by the 
applicant with potential modifications based on recommendations of the 
Initial Review Committee:

A.  CFAR Strategic Plan
B.  CFAR Policies and Procedures
C.  CFAR Advisory Committee(s) authority and responsibility
D.  CFAR Advisory Committee for the identification and selection of research   
projects and awards (D-CFAR)

Any changes in these items from the Notice of Award will require concurrence 
of NIH.

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/
notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines 
are available at http://grants.nih.gov/grants/funding/women_min/
guidelines_amended_10_2001.htm  The amended policy incorporates: the use 
of an NIH definition of clinical research; updated racial and ethnic categories 
in compliance with the new OMB standards; clarification of language governing 
NIH-defined Phase III clinical trials consistent with the new PHS Form 398; 
and updated roles and responsibilities of NIH staff and the extramural 
community.  The policy continues to require for all NIH-defined Phase III 
clinical trials that: a) all applications or proposals and/or protocols must 
provide a description of plans to conduct analyses, as appropriate, to address 
differences by sex/gender and/or racial/ethnic groups, including subgroups if 
applicable; and b) investigators must report annual accrual and progress in 
conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  tc 
"REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS" NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is in the NIH Guide for Grants and 
Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  
 
Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

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

AUTHORITY AND REGULATIONS

This program is described in the Catalogue of Federal Domestic Assistance at 
http://www.cfda.gov/ in the following citations; No. 93.213, Research and 
Training in Complementary and Alternative Medicine; No. 93.242, Mental Health 
Research Grants; No. 93.279, Drug Abuse Research Programs; No. 93.393, Cancer 
Cause and Prevention Research; No. 93.394, Cancer Detection and Diagnosis 
Research; No. 93.396, Cancer Biology Research; No. 93.839, Blood Diseases and 
Resources Research; No. 93.855, Immunology, Allergy, and Transplantation 
Research; No. 93.856, Microbiology and Infectious Diseases Research; No. 
93.864, Population Research; No. 93.865, Center for Research for Mothers and 
Children; and No. 93.989, Senior International Fellowships.  Awards are made 
under authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284) and administered under NIH grants policies 
and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program 
is not subject to the intergovernmental review requirements of Executive 
Order 12372 or Health Systems Agency review.

The NIH Grants Policy Statement is available at 
http://grants.nih.gov/grants/policy/policy.htm. This document includes 
general information about the grant application and review process; 
information on the terms and conditions that apply to NIH Grants and 
cooperative agreements; and a listing of pertinent offices and officials at 
the NIH.  All awards are subject to the terms and conditions, cost 
principles, and other considerations described in the NIH Grants Policy 
Statement. 

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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