CENTERS FOR AIDS RESEARCH (CFAR) AND DEVELOPMENTAL CFAR (D-CFAR)
Release Date: February 9, 2000 (see replacement PAR-03-089)
PA NUMBER: PAR-00-054
National Institutes of Health
Letter of Intent Receipt Date: April 17
Application Receipt Date: June 1, 2000; June 1, 2001; June 1, 2002
PURPOSE
This program announcement replaces PAR-98-043 published in the NIH Guide,
March 20, 1998.
Participating Institutes of the National Institutes of Health (NIH) invite
applications for center core grants (P30) to support Centers for AIDS Research
(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
are not intended to be "Centers of Excellence" in specific areas of AIDS
research, but instead 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. Before
preparing an application to support a CFAR or D-CFAR, investigators are urged
to consult with the program staff listed under "Inquiries."
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.
HEALTHY PEOPLE 2000
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS led national
activity for setting priority areas. This Program Announcement (PA), Centers
for AIDS Research (CFAR) and Developmental CFAR (D-CFAR), is related to
priority areas 4 (Substance Abuse: Alcohol and Other Drugs), 6 (Mental Health
and Mental Disorders), 14 (Maternal and Infant Health), 15 (Heart Disease and
Stroke), 16 (Cancer), 18 (HIV Infection), 19 (Sexually Transmitted Diseases),
20 (Immunization and Infectious Diseases), and 21 (Clinical Preventive
Services). Potential applicants may obtain a copy of "Healthy People 2000" at
http://odphp.osophs.dhhs.gov/pubs/hp2000.
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. NIH AIDS Funded Research Base
The purpose of CFARs is to support the AIDS research activities of
investigators at applicant institution(s) that have significant NIH funding
for AIDS research. Significant NIH AIDS funds are defined as an NIH AIDS
Funded Research Base in excess of $6 million in annual total cost for the NIH
fiscal year (October 1 to September 30) preceding receipt of CFAR
applications. (FRB). The FRB includes the total cost of research awards and
the number of these awards to investigators participating in the CFAR. The
research base includes peer-reviewed AIDS grants, cooperative agreements, and
research contracts utilizing only the following mechanisms: P01, R01, R03,
R21, R29, R35, R37, U01, U10, U19, and K series awards, R18, 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.
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 investigators at that institution.
B. 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.
C. Two types of CFAR awards
This program announcement describes two types of CFAR awards. The first is
for a standard CFAR, and does not differ significantly from currently funded
CFARs. The second is a Developmental CFAR (D-CFAR) for AIDS investigators at
an institution, which while eligible, 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
D-CFAR award is described in more detail below.
COMPARISON OF CFAR AND D-CFAR AWARDS
CFAR D-CFAR
MAXIMUM FUNDING $1.5M $750K
FUNDING PERIOD 5 years 3 years
COMPETITIVE RENEWAL Allowed Not allowed
FOCUS Support all Become competitive for CFAR
NIH AID
investigators
at institution
D. 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.
A multi-institutional CFAR application must designate a prime institution that
will receive the award and provide details of agreements regarding
coordination and support of cores and activities at other participating
institutions.
E. Cores outside of the CFAR institution
With appropriate justification, CFAR awards may support a core at a distant
site, including a foreign site that provides a unique resource such as a
primate facility or a high-resolution NMR facility. To achieve administrative
efficiency and foster collaboration, each unique resource should serve as a
core for only a single CFAR, and that all cores within any single outside
institution should be part of the same CFAR award. NIH AIDS funding of the
investigators at this core facility is not included as part of the Funded
Research Base of the CFAR (see Funded Research Base, below).
F. 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 over site of the
CFAR grants will be provided through an NIH CFAR Steering Committee composed
of representatives from the co-funding NIH Institutes and from the Office of
AIDS Research (OAR). It is therefore suggested that the applicant first
contact the NIAID program representatives listed under Inquires to discuss
general CFAR issues and then to contact other program representatives listed
under Inquires to discuss how CFARs can enhance the AIDS research already
being funded by each NIH Institute.
G. CFAR support for all NIH AIDS investigators
NIH will provide applicants with a spreadsheet (Excel) 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 include this spreadsheet in their application.
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 delineate 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.
H. Funds available
A CFAR award (total cost) will be limited to 10% of the amount of funds
received by the applicant institution(s) for AIDS research as reported by OAR
for the NIH fiscal year preceding receipt of the application. New CFAR awards
will not exceed $1.5 million annually. Recompeting CFARs will be limited to
an inflationary increase beyond the funding level of the current grant, or
$1.5 M, whichever is greater. If the Funded Research Base of a recompeting
CFAR should go below $15M, the applicant is limited to requesting 10% of the
new Funded Research Base.
MECHANISM AND LENGTH OF SUPPORT
This PA will use the National Institutes of Health (NIH) Center Core Grant
(P30) award mechanism. Responsibility for the planning, direction and
execution of the proposed project will be solely that of the applicant. The
total requested project period may not exceed five years for a standard CFAR
and applicants are encouraged to apply for five years. For D-CFARs, the total
requested project period may not exceed three years.
BACKGROUND
The CFAR program was established in 1988 and was renewed in 1993 and 1997. 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 have
been 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 and 1998.
The mission of the CFARs is to support a multi-disciplinary environment that
promotes basic, clinical, 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 dedicated to AIDS research
B. Providing institutional infrastructure dedicated to AIDS research
C. Stimulating scientific collaboration and translational research
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. Facilitating development of AIDS therapeutics, vaccines and diagnostics
through promotion of scientific interactions between CFARs and industry.
RESEARCH OBJECTIVES FOR CFARS AND D-CFARS
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: interdisciplinary
publications; evidence of CFAR enhancement of existing programs at the
institution; the number of protocols started within the institution; patent
applications filed or issued; institutional support for activities previously
supported by the CFAR. For recompeting CFARs, Tables 1 and 2 are provided on
the CFAR web site (http://www.niaid.nih.gov/research/cfar/cfarpa.htm) , which
should be used by the applicant to show various translational research
activities. The activities shown are not meant to be all-inclusive.
B. CFAR 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 been responsive to all AIDS
investigators at their institution. 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.
C. CFARs have scientific and fiscal flexibility and responsibility
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 the 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 that will permit the establishment of new
cores, as needed, without additional funding.
The extent to which FAR 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 by CFAR funds, or only 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.
D. Additional CFAR supported activities
CFARs traditionally use a variety of strategies to achieve the research
objectives of the award. Examples include industry collaborations,
development of minority scientists in AIDS research, AIDS research
communications to non-scientists, addressing problems in enrollment and
retention of women and minority groups in AIDS clinical trials, international
collaborations, 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 types of funding mechanisms.
Coordination with international programs funded by the Fogarty Center are
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 support
for the preparation of developmental award applications;
2. Establishing a collaboration between investigators at institutions in the
developing world that could include mini-sabbaticals to the CFAR for use of
core facilities by the investigator at the distant site and mentoring of
investigators in the developing world by CFAR investigators at the distant
site, 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
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 cores selected to
optimally support the AIDS research at the applicant institution(s). The
smallest CFAR would consist of one of each type of core (administrative,
developmental, basic, and clinical). The terms basic and clinical cores are
generic names, 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.
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 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 that is a clearly separate entity, and a modest staff for support
of CFAR activities. The responsibilities and time allocation of each staff
person and the proposed operation 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. Successful applicants are required to go through an
annual strategic planning process to assess current and expected scientific
and fiscal needs and planned adjustments, according to the stated policies and
procedures.
a) Strategic plan
The purpose of the strategic plan is to identify the most significant
opportunities and gaps in science at the applicant institution that will be
addressed by the CFAR in the short and long term, and to identify objective
milestones to 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. Outline the major AIDS studies to be assisted by CFAR funding and
organize them by relevancy to the mission of co-funding Institutes (one page
or less is suggested per funding Institute). Cite grant numbers listed in the
Excel table showing the NIH AIDS Funded Research Base of the institution(s).
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 CFAR 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 membership of all committees, how
participants were selected, and terms of appointment, authority and
responsibility of members.
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, and evidence
of the selection and organization of additional cores through acquisition of
information, support, and participation of the AIDS investigators at the
applicant institution(s).
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 only one area that the CFAR will consider in
the development of policies and procedures.
o CFAR funding will be allocated by discipline in proportion to research
performed in those disciplines.
o CFAR funding will be allocated for projects based on a majority vote of all
CFAR members.
o CFAR funding will be 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. The policies
and procedures should describe:
o the proposed roles of the CFAR director, core directors, CFAR
investigators, advisory boards, institutional officials, and NIH program staff
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 research basic and clinical core
needs at the applicant institution(s), assign priorities to potential cores,
and select the basic and clinical cores that are 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 using the developmental core to
fund a collaborative study that encompasses two scientific disciplines,
especially two that may not have traditionally collaborated (q.v., 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 the 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. Applicants who have current CFARs should describe outcome
evaluation of previously funded developmental projects. The applicant should
use the table provided for this purpose 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 support shared 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 anticipated users and the
percent time of use by each. Mechanisms should be described to prioritize
usage, evaluate annual use, and justify level of continued CFAR support in
comparison with other AIDS research needs at the applicant institution(s).
4. Clinical Cores
Clinical cores should have a clear focus and provide the resources for AIDS
translational research collaboration between clinical and basic scientists.
Activities that will not be supported by a CFAR clinical core are normal
patient care including screening of clinical specimens, diagnosis, treatment
or rehabilitation. 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.
Mechanisms should be described to prioritize usage, to evaluate annual use,
and to justify the level of continued CFAR support in comparison with other
AIDS research needs at the applicant institution(s).
F. Institutional Commitment
Institutional commitment 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: the level
of institutional funding, space allocations, co-funding, endowments,
designating the status of a center program in the institutional bylaws, and
providing a waiver or partial waiver for indirect costs for certain components
of the grant, such as funding through the developmental core. These are
examples, and are not exclusive of other possible ways in which an institution
may demonstrate support for the CFAR. 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 will have over other
AIDS projects, facilities and space, as well as decision-making authority for
new faculty and support personnel.
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 activities. 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, the CFAR administrator, and
one senior scientist per center will 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 director’s 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. 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. These additional travel funds should
not exceed $20,000 annual direct costs.
DEVELOPMENTAL CFARs (D-CFAR)
The NIH recognizes the need to provide funding to potential CFAR awardees who
need to expand or enhance a particular CFAR component in order to facilitate
collaborative interactions. For example, applicants may wish to expand AIDS
complementary or alternative medicine, behavioral science, or basic science 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 traditionally collaborated (q.v., basic scientists and scientists
studying complementary and alternative medicine, such as chiropractic or
acupuncture; or behavioral scientists and population geneticists), 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 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
applications from previous CFARs regarding the feasibility of overcoming
obstacles previously identified by review committees. 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 for the procedures 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 the 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 does not support research activities,
except through the developmental core, for limited funding, and for limited
periods of time. It does provide 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 encourages 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 with 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.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided 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 research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23,
No. 11, March 18, 1994 available on the web at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH 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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the identities of other key personnel
and participating institutions, and the number and title of this program
announcement. Although a letter of intent is not required, is not binding,
and does not enter into the review of subsequent applications, the information
allows staff to estimate the potential review workload and to help avoid
conflict of interest in the review. The letter of intent is to be sent to Dr.
Dianne Tingley at the address listed under INQUIRIES by the letter of intent
receipt date listed in the heading of the program announcement.
APPLICATION PROCEDURES
Applicants are strongly encouraged to contact program staff early in
application development with any questions regarding the responsiveness of
their proposal to the goals of this PA.
A. Application form
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the application deadlines indicated on page one
of this program announcement. Application kits are available at most
institutional offices of sponsored research and may be obtained from the
Division of Extramural Outreach and Information Resources, National Institutes
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/435-0714, email: GrantsInfo@nih.gov.
Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact the
Institute or Center (IC) program staff before submitting the application,
i.e., as plans for the study are being developed. Furthermore, the application
must obtain agreement from the IC staff that the IC will accept the
application for consideration for award. Finally, the applicant must identify,
in a cover letter sent with the application, the staff member and Institute or
Center who agreed to accept assignment of the application.
This policy requires an applicant to obtain agreement for acceptance of both
new and amended application and any such subsequent amendment. Refer to the
NIH Guide for Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html
The title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
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.
B. Limitation on Submission of Amended/Revised Applications
In June 1996, NIH announced a policy limiting the number of amended versions
of an application that will be accepted to two. This policy applies to all
grant mechanisms. If an applicant is not successful after three attempts at
funding (the initial submission and two revisions), she/he is expected to make
a significant change in the direction and approach for subsequent research
applications. Additional information can be found at the following sites:
http://grants.nih.gov/grants/policy/amendedapps.htm and
http://grants.nih.gov/grants/guide/notice-files/not99-146.html (Item 2).
Prior to preparation of a new application after three submissions, applicants
are strongly encouraged to discuss plans with the program contacts listed
under Inquiries .
C. Page limitations
For applications in response to this program announcement, the page limitation
is 300 pages for the entire CFAR or D-CFAR application, excluding only
appendices. 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. The 300-
page limit is a maximum and applicants are encouraged to be concise.
Applicant submitting a revised application may include an additional 30 pages
to discuss the response to the reviewer’s 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.
D. 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 field provided, those investigators who have
formally agreed to participate in the CFAR. Please contact Dr. Janet Young
(Contact information will be found under Inquiries .)
The NIH will provide tables in Word 2000 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
In the future the NIH may provide these tables in the form of an Access
database.
E. Organization of Application
In order to facilitate the review process, applicants should follow the
instructions described in Special Instructions for Preparation of the CFAR
Application. The Special Instructions provides information on how to organize
and present information in the CFAR application to facilitate review and
award. The CFAR web site includes the Special Instructions and the CFAR
Program Announcement:
http://www.niaid.nih.gov/research/cfar/cfarpa.htm
Printed copies of both documents may be obtained from the Program Staff listed
below.
F. Mailing Instructions
Applications must be mailed to both the NIH Center for Scientific Review and
to the NIAID Division of Extramural activities. For purposes of
identification and processing, Item 2 on the face page of the application must
be marked yes . Also, the title and number of this program announcement must
be typed in Item 2 (i.e., CENTERS FOR AIDS RESEARCH (CFAR), or DEVELOPMENTAL
CENTERS FOR AIDS RESEARCH (D-CFAR), PAR-00-054). The completed signed
original application (text + appendices) and three single-sided copies of the
application (text) must be sent or delivered 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 or delivered to: Dianne Tingley, listed under
Inquiries .
REVIEW CONSIDERATIONS
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 that are complete and responsive will be evaluated for scientific
and technical merit by an Initial Review Group (IRG) of NIAID. As part of the
initial merit review, all applications will receive a written critique, be
assigned a priority score, and receive a second level review by an appropriate
national advisory council(s) or board(s).
REVIEW CRITERIA
Review criteria are based on the mission of the CFAR Program and mechanisms
for achieving this mission. The initial review group (IRG) will evaluate CFAR
and D-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 of 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
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 standard CFAR and the developmental CFAR (D-CFAR) awards.
REVIEW CRITERIA FOR STANDARD CFARS
Significance The effect that a CFAR award would have on an applicant’s 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 their
selection
Environment The likelihood that a CFAR will achieve its objectives
12. Evidence for CFAR providing value added to the 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 support for developmental projects and outcomes
15. Previous history of translational research efforts
16. Appropriateness of budget of the overall CFAR and of the individual cores
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 CFAR application
that would be competitive for a standard CFAR award
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 focus 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
In addition, applicants for either the CFAR or D-CFAR award must demonstrate
adequate provisions for the protection of human and animal subjects, the
safety of the research environment, and conformance with the NIH Guidelines
for the Inclusion of Women and Minorities as Subjects in Clinical Research
and Guidelines for the Inclusion of Children as Research Subjects .
AWARD CRITERIA
Applications will compete for available funds with all other approved
applications. The following will be considered in making funding decisions:
A. Quality of the proposed project as determined by peer review
B. Availability of funds
C. Institute's priority for area of proposed research
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
Any changes in these items from the Notice of Award will require concurrence
of NIH.
INQUIRIES
A. Electronic communication
The opportunity to clarify any issues or questions regarding CFARs or CFAR
applications is welcome. Especially encouraged are inquiries through the CFAR
web site:
http://www.niaid.nih.gov/research/cfar/cfarpa.htm
In addition to submitting inquiries at this web site, applicants may view
inquiries by others, read the official NIH responses, and obtain suggestions
for application organization.
B. NIAID Review Staff
Questions on review issues may be directed to:
Dianne Tingley, Ph.D.
Scientific Review Program
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2148
6700-B Rockledge Drive MSC 7616
Bethesda, MD 20892-7616
Telephone: (301) 496-2550
FAX: (301) 402-2638
Email: dt15g@nih.gov
For express/courier service: Bethesda, MD 20817
C. NIAID Grants Management Staff
Questions on fiscal issues may be directed to:
Ms. Victoria Putprush
Grants Management Branch
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2124
6700-B Rockledge Drive - MSC 7614
Bethesda, MD 20892-7614
Telephone: (301) 402-6580
FAX: (301) 480-3780
Email: vp8g@nih.gov
D. NIH CFAR and D-CFAR Steering Committee for programmatic issues
Questions regarding CFAR or D-CFAR management issues, scientific issues, or
program interests of NIAID may be directed to:
Janet M. Young, Ph.D.
Basic Science Program
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4137
6700-B Rockledge Drive MSC 7626
Bethesda, MD 20892-7626
Telephone: (301) 496-6714
FAX: (301) 402-3211
Email: jy6r@nih.gov
Questions related to CFAR and D-CFAR scientific and program interests of other
Institutes and Centers may be directed to:
FIC
Kenneth Bridbord, M.D.
Director
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
31 Center Drive MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-2516
FAX: (301) 402-2056
Email: bridbord@nih.gov
NCI
Jaswant Bhorjee, Ph.D.
Program Officer
Cancer Centers Program
OCTR, OD
National Cancer Institute
6130 Executive Boulevard, Room 502
Rockville, MD 20852
Telephone: (301) 496-8531
FAX: (301) 402-0181
Email: jb118r@nih.gov
NCCAM
Richard Nahin, Ph.D., MPH
Division of Extramural Research
National Center for Complementary
And Alternative Medicine
Bldg. 31, Room 5B-58
31 Center Drive MSC 2182
Bethesda, MD 20892-2182
Telephone: (301) 496-4792
FAX: (301) 402-4741
Email: NahinR@od.nih.gov
NHLBI
Elaine Sloand, M.D.
AIDS Coordinator
Office of the Director
National Heart, Lung and Blood Institute
Bldg. 31 Room 4A11
31 Center Drive MSC 2490
Bethesda, MD 20892-2490
Telephone: (301) 496-3245
FAX: (301) 594-1290
Email: es38n@nih.gov
NICHD
Patricia Reichelderfer, Ph.D.
Microbiologist
Contraception and Reproduction Evaluation Branch
National Institute of Child Health and Development
6100 Executive Boulevard, Room 8B13
Rockville, MD, 20852
Telephone: (301) 496-1661
FAX: (301) 480-1972
Email: pr20f@nih.gov
NIDA
Jag Khalsa, Ph.D.
Health Scientist Administrator
National Institute on Drug Abuse
Neurosciences Center
Room 5198
6001 Executive Blvd., MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 443-1801
FAX: (301) 594-6556 or 443-4100
Email: jk98p@nih.gov
NIDDK
Philip F Smith, Ph.D.
Senior Advisor for Neuroendocrinology
and Endocrinology of Obesity
National Institute of Diabetes and Digestive and Kidney Diseases
Natcher Bldg room 5AN-12C, MSC 6600
Bethesda MD 20892-6600
Telephone: (301) 594-8816
FAX: (301) 480-3503
Email: ps56z@nih.gov
NIMH
Dianne Rausch, Ph.D.
Deputy Director
Center for Mental Health Research on AIDS
National Institute of Mental Health
Neurosciences Center
Room 6209
6001 Executive Blvd., MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-7281
FAX: (301) 443-9719
Email: dr89b@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance,
93.856 - Microbiology and Infectious Diseases Research and 93.855 -
Immunology, Allergy and Transplantation Research. Awards are made under
authorization of the Public Health Service Act, Title IV, Part A (Public Law
78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered
under NIH grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR
Part 74 and 92. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-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, and 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
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