ALCOHOL RESEARCH CENTER GRANTS
RELEASE DATE: June 23, 2004
RFA Number: RFA-AA-05-001
EXPIRATION DATE: December 17, 2004 (This PA has been modified, see RFA-AA-07-002
and RFA-AA-07-003)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.891
Letter of Intent Receipt Date: November l5, 2004
Application Receipt Date: December 16, 2004
THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION:
o Purpose of this RFA
o Research Objectives
o Mechanism(s)of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides
grant support for Alcohol Research Centers to conduct and foster
interdisciplinary research on alcoholism and alcohol abuse. The Alcohol
Research Centers program is interrelated with, and complementary to,
all other research support mechanisms and scientific activities that
comprise NIAAA programs of research on the nature, causes, and
consequences of alcohol abuse and alcoholism, including diagnosis,
treatment, prevention, and health services research related to
prevention and treatment of alcoholism, or any other emerging areas in
genomics, metabolomics, or proteomics. Centers are designed to
stimulate and encourage application of a wide array of approaches,
perspectives and technologies to the understanding of alcoholism,
alcohol abuse, and alcohol-related disorders.
Support for four of the current 5-year Center grant awards will expire
in late 2005 and early 2006. Research within each of these Centers is
organized around a central theme: genetics of neuroadaptation to
alcohol; translation of neuroscience research results to clinical
application; pharmacological and behavioral therapies for alcoholism
and comorbid disorders; epidemiology of consumption patterns, trends
and alcohol related problems in the general population. Applications
for new centers in these and other priority research areas such as
improving prevention interventions and treatment effectiveness or
mechanisms of alcohol action and injury will be accepted with
applications from currently funded centers seeking renewal support.
RESEARCH OBJECTIVES
All proposed research to be conducted within a Center must be clearly
directed toward one or more of the following goals: prevalence,
etiology, diagnosis, prediction, clinical course, management or
treatment of alcohol abuse, alcoholism, or alcohol-related health
problems; health services research; basic research on consequences of
alcoholism or alcohol abuse; statistical modeling of predicted or
forecasted outcomes utilizing existing data sets; and factors that
relate to prevention of alcohol abuse, alcoholism, or other problems
associated with alcohol consumption. Some examples include research to
improve knowledge of the impact of alcohol use on related health fields
such as human development, growth and aging; cardiovascular integrity
and functioning; disease pathogenesis and progression; population
mortality; attributable risk; long-term utilization of alcohol-related
health services; liver and gastrointestinal functioning; nicotine and
other drug use; performance ability; neurological impairment; mental
disorders that co-occur with alcohol abuse disorders and potential
benefits of non-abusive alcohol beverage consumption.
The Alcohol Research Center grant provides a mechanism for fostering
interdisciplinary cooperation within and among a group of established
investigators conducting high-quality alcohol research. Therefore,
existence of a strong research capability is fundamental to the
establishment of a new Center or the continuation of an existing
Center. A Center should be an identifiable organizational unit within
an institutional or organizational structure such as a university,
medical center, or a consortium of affiliated cooperating institutions.
Unique scientific opportunities including sharing of resources and
expertise warrant collaboration with investigators from other centers
or settings and/or with scientists in institutions outside the United
States. In these cases the director of the component(s) in which
collaborative activity with a foreign organization is proposed should
be affiliated with a domestic institution.
Center Components
The following paragraphs describe the specific components of a Center
Grant application:
Administrative Core Component
A Center should promote synergistic interaction of broad and diverse
elements that require clearly specified lines of authority and
accountability by appropriate institutional officials. The purpose of
the administrative core component is to provide the organizational
framework for the management, direction, and coordination of the
Center. The administrative core component must be managed by the
Center Director or Scientific Director and may include funds for
scientific enrichment activities such as special lectures, symposia,
seminars, and workshops for research faculty and staff.
Scientific Core Components
Core components for this RFA are defined as shared research resources
that enhance productivity or in other ways benefit a group of
investigators working in alcohol-related research to accomplish the
common goals of the Center. A core component is a laboratory,
facility, service, or other resource that interacts synergistically
with research projects of the Center. Cores should primarily be used
to support projects which are part of the Center Grant award, but they
may also be used for other support mechanisms such as Research Project
Grants, Program Projects, or a combination thereof, that have relevance
to the NIAAA mission. Core components should provide investigators with
some technique, instrumentation, service, or resource in a way that
will enhance research progress and contribute to efficiency and
effectiveness. Each core component is directed by an investigator with
established expertise relevant to the support or service to be
provided, usually a faculty-level individual. Some examples of research
support that core components typically provide are: (1) technology that
implements automation or large batch preparation; (2) tissue and/or
cell culture facilities; (3) complex instrumentation, e.g., electron
microscopy, mass spectrometry, electrophysiology; (4) animal
production, care and preparation; (5) service and training; (6) patient
coordination; and (7) information processing, data management, and
statistical services.
Research Components
Research components are individual scientific research projects,
interrelated within the overall Center program so that the components
contribute collectively to the goals of the Center program to a greater
extent than if each project were pursued separately. Each research
component must be a highly focused project under the direction of a
component director. The component director should be an established
researcher of independent and scientifically recognized standing who is
responsible for the scientific direction and conduct of the individual
research component. A Center Director or Scientific Director may also
serve as a component director.
Education Component (for P60 applications)
Comprehensive centers (P60) must include at least one component which
supports activities designed to translate research findings into health
care practice, public information dissemination, or education curricula
or programs for students, health professionals and community agencies.
Such activities may require a substantial portion of the first year for
planning and development with actual implementation beginning near the
second year and continuing in subsequent years. These projects shall in
a meaningful way reflect the Center's program of research. The
following examples are types of projects that may be undertaken but are
not intended to be limiting:
Translational Research: The development of collaborative partnerships
to advance the alcohol research field through translation of insights
and findings from basic and pre-clinical research to test hypotheses
regarding treatment and prevention of alcohol disorders; to improve
interventions with alcohol affected individuals in clinical practices,
health care or community settings; or the development of innovative
interventions to study the effects of services for diverse populations
in disparate social, cultural and environmental contexts.
Dissemination of Scientific Information and Research Progress:
Dissemination of scientific knowledge through educational efforts
directed to the public, patient populations, professionals and para-
professionals; providing information to educational institutions, the
media and other appropriate organizations/groups; and educational
programs for specific audiences, e.g., children, women, elderly etc.
Dissemination of scientific knowledge through the establishment of
research and research training collaborations for the purpose of
expanding the capacity of other institutions including minority serving
institutions, in developing rigorous alcohol research programs.
All translational and educational projects should have specific
objectives and include a method of assuring the effectiveness of the
effort.
Pilot Project Component
The purpose of pilot projects is to provide the Center with a flexible
means to develop and explore new research activities or directions, and
unique scientific opportunities that could evolve into independently
funded research projects. These funds are not intended to supplement
ongoing research projects. Pilot projects must be in a separate pilot
project component that incorporates all of the pilot studies proposed
for all five years of the center grant including likely topics for
replacement of completed pilot studies.
MECHANISMS OF SUPPORT
This Request for Applications (RFA) will utilize the NIH P50 and P60
mechanisms.
The Alcohol Research Centers Grant program is designed to complement
the regular research project grants program of the NIAAA by providing
long-term (typically for 5 years) support for interdisciplinary
research programs with a distinct focus on a particular theme related
to alcoholism, alcohol abuse, and other alcohol-related problems. The
program is intended to encourage outstanding scientists from
biomedical, behavioral, quantitative, social sciences and other
relevant disciplines to bring a full range of expertise, approaches,
technologies and creativity to the study of problems related to alcohol
abuse and alcoholism. Center grants help to provide a stable
environment for investigators to engage in alcohol research in a
coordinated, integrated and synergistic effort. Centers are expected
to be sources of scientific excellence, provide leadership to the
field, and, through sustained excellence, to become significant
regional or national research resources. In addition, they are
expected to attract promising and established investigators and to
provide training, career development and mentoring opportunities to
persons from various disciplines and professions.
A specialized center (P50) is an integrated, broad-based
multidisciplinary, multi-investigator, long-term program of combined
research and research support activity planned around a specific major
research objective or research theme. In addition to providing support
for shared resources, this type of Center supports a full range of
basic, developmental, clinical, and/or applied research components;
allows for growth and development through pilot projects; and is
intended to provide state-of-the-art leadership in the alcohol field.
A comprehensive center (P60) expands the specialized center program of
research and research training by inclusion of additional components or
elements developed in conjunction with available community based
agencies, institutions, facilities and resources. Projects could
include community education and alcohol information dissemination to
the public and education for medical and allied health care
professionals concerning the problems of detection, diagnosis,
treatment and prevention of alcohol dependence and alcohol abuse.
While not all of these areas must be represented in one center, the
community education or information dissemination project proposed
should be a comprehensive approach and have a clear relationship to the
research theme of the center.
FUNDS AVAILABLE
It is estimated that approximately $8.0 million dollars will be
available in FY 2006 to fund four or five Centers. The total cost
(direct plus Facilities and Administrative (F&A) costs) for a Center
may not exceed $1.8 million per year for a P50 and $2.0 million per
year for a P60. Continuation support in future years is anticipated.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
o Faith-based organizations
In addition, the proposed Center must be affiliated with an
institution, such as a university, medical center, or research center
that has the resources to sustain a long-term, coordinated research
program. An applicant institution must demonstrate the ability to
attract high-quality scientists from biomedical, behavioral, clinical
and/or social science disciplines that are willing to make a long-term
commitment to research, and must assure that research-training
opportunities will be available. An application must also have a
detailed 5-year plan for a proposed research program.
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 individual named as principal investigator for the Center grant
will also serve as Director of the Center. This individual must
demonstrate the ability to organize, administer, and direct the Center,
and have sufficient authority to allocate space, personnel, and other
resources essential to the Center.
SPECIAL REQUIREMENTS
The following paragraphs describe the Special Requirements for a Center
application. Details for preparing the application are provided in the
Supplemental Instructions (see Item 11) It is essential that applicants
carefully adhere to the Supplemental Instructions.
Center grant applications should be organized into discrete components
that comprise a proposed program of research. Each component is either
a research component or a core component for which a separate detailed
budget is included in the application. The application must include an
administrative core and at least three research components; it may also
include shared scientific resource cores, education on translational
research component for P60s, and/or a pilot project component.
The minimum acceptable combined number of research components and core
components is four (an administrative core and three research
components). The maximum combined number of research components and
core components, including a pilot project component, is 10. An
education component does not count toward this total. More than a total
of 10 components are not acceptable even if some components are in
operation for less than the 5-year period. All proposed research
components need not be ongoing at any one time, but may be phased in at
different time points during the life of the proposed Center grant. At
least three research components must be ongoing at all times, and no
more than 10 research and/or core components may be proposed over the
entire project period. Education components do not count toward the
required three research components. This aspect should receive careful
attention in the application and individual component preparation.
The research plan for each core component, each research component, and
each education component is limited to 25 pages. Pages not used for one
component may not be used to extend the page limit of other
components/cores. These page limits do not apply to pilot projects.
For pilot project requirements, see section entitled "Pilot Project
Component," (below).
Administrative Core Component
The administrative core component plays a key role in the coordination
and operation of the Center. This core should be described in
sufficient detail to assure that all proposed components and related
activities will function optimally and in an interactive synergistic
manner. An important function of this core is the administration of
the budget. Through this component, the Center Director provides
substantive leadership and manages the administrative core component.
This component may also include the costs of scientific enrichment and
education activities for faculty and staff.
Scientific Core Components
Each shared scientific resource component should be clearly described
in terms of the services/resources to be provided to investigators.
The description should include a discussion of the core's contributions
to the research objectives of the Center. Relevant aspects of cost
effectiveness, timesaving, and increased efficiency attributable to the
existence of the cores should also be addressed. A core component
should support Center grant research components and may also support
separately funded research project grants that are related to the
Center's theme. Each separately funded research project associated
with the Center and utilizing core facilities should have a brief
description that includes its research objectives and how the Center's
core facility will impact upon it. The minimum number of research
components/projects to be supported by a core component is two.
A core component director who has documented experience and scientific
expertise relative to the purpose of the core must be designated for
each core. This person should be an established scientist in his or
her field. The description of the organization and mode of operation
of the shared resource core should include discussion of quality
control for the service or resource, and the procedures for evaluating
and selecting projects eligible for use of the core facility. Training
in complex techniques and methods should be described if they are
functions in proposed cores. Core components are intended to enhance
opportunities for investigators at the Center to include new
technologies that broaden their research initiatives. While, research
per se is not conducted as part of the scientific core, quality
assurance activities that evaluate the operation, resources, quality
and utilization of the core and that are directed at problem
identification and improvement of core functioning are appropriate.
In renewal applications, ongoing or completed core activity that has
enhanced or facilitated alcohol research should be described. Past
performance and accomplishments of cores should be described, as should
the effect of services provided by cores on investigators'
productivity.
Research Components
For each proposed research component, a clear description of the major
goals, objectives, and its integration with the other components in
relation to the overall Center program should be provided.
o The question(s) to be addressed and the hypotheses to be tested by
the proposed research should be highly focused and fully explained.
o A discussion of the design and procedures should describe the
strategies proposed to accomplish the specific aims of the project and
highlight innovative aspects of the approach.
o A description of the resources and working arrangements required to
implement and conduct the proposed research should be fully elaborated
with particular attention devoted to a description of necessary
resources, subjects, clinical populations, tissue resources, biological
models, existing data sets, etc., which will be involved in proposed
studies. If core facilities are utilized, information on their use
should be provided.
Education Component (for P60 applications)
For each education/translation component, a clear description of the
major goals, objectives, and its integration with the research
components in relation to the overall center program should be
provided. Specific projects for translational education/information
dissemination activities should be described. While the specific
number of education projects is at the discretion of the applicant,
requested funding for education component activities may not exceed
$100,000 or 10 percent (whichever is larger) of the direct cost budget
proposed for any one year. A staffing plan and rationale for
organization of this component should be presented. Methods,
techniques, and technologies to be used for proposed activities should
be defined as well as the targeted audience or participants. Issues of
cultural sensitivity with regard to intended audience should be
addressed. When appropriate, activities should be designed to
effectively reach underserved populations and/or subgroups based on age
or gender.
o The scientific knowledge base and research topics or areas upon which
proposed translational activities will be developed should be
identified and explained.
o A discussion of the design, plans and procedures for development
including time lines should describe strategies proposed to accomplish
specific aims of the project(s). Innovative aspects of the approach to
be used should be highlighted.
o A description of the resources, facilities, agencies, and/or
institutions with working arrangements to plan, implement and conduct
the proposed activities should be fully elaborated. Particular
attention must be devoted to a description of necessary resources,
including specialized expertise, and the target audience or
participants who will derive benefit from the activity. If core
facilities or services are utilized, information on their use should be
provided.
o A description of plans to evaluate the success and/or effectiveness
of educational translational activities with emphasis on their impact
on knowledge, attitudes, and behaviors should be described.
Pilot Project Component
The process for selecting pilot projects should be fully, thoroughly,
and concisely described. For the first 2 years that funds are
requested for pilot projects, the application must provide descriptions
of the projects to be supported. For years 03-05, the application must
provide the specific number of pilots planned in each year and a brief
description of the anticipated direction of these pilots. While the
specific number of pilot projects to be proposed is at the discretion
of the applicant, requested funding for pilot studies may not exceed
$100,000 or 10 percent (whichever is larger) of the direct cost budget
proposed for any 1 year. All proposed pilot projects need not be
ongoing at any one time, but may be phased in at different points
during the life of the proposed Center grant. It is recognized that the
relative priority or need for specific pilot projects may change over
the course of time.
While the Center's framework for management of pilot funds and the
mechanism for operating the program are left to the discretion of the
Center, the application must provide sufficient information to enable
adequate scientific evaluation by a peer review committee. The
application should include:
o A full description of the management of the pilot project component,
including a description of the process utilized by the Center Director
in soliciting and selecting pilot projects. The process to be followed
in selecting new projects and/or projects to replace those proposed in
the application, should it become necessary, must also be fully
described.
o A full description of each pilot study proposed in the first 2 years,
including its rationale, objectives, approach, investigators, and
significance for the Center. A brief description (2 to 3 Pages) and
anticipated direction of pilot projects planned for the 03-05 years,
including their significance to the Center. The research description
of any individual pilot project may not exceed five pages; the entire
narrative for this Pilot Project Component may not exceed 25 pages
irrespective of the number of pilot projects proposed.
o For competing renewal applications, information should be provided on
past experience in utilizing pilot funds to further Center goals. This
should include an assessment of overall benefits derived from the
availability of pilot resources.
A budget should be submitted for the pilot project component as a whole
for each year in which pilots are proposed and for each individual
project. For years 01 and 02 the budget will reflect costs of pilots
proposed in the application. Budget information provided for each
project anticipated for the 03-05 years should reflect best estimate
costs based on number and kind of pilot projects to be pursued.
Supplemental Instructions provide further information on pilot project
description requirements.
Renewal Applications
A comprehensive progress report is required for competing continuation
(renewal) applications. A statement must be included in the application
regarding the progress made by the Center as a whole in its development
as a national or regional research resource. Collaborative activities
with other NIAAA Alcohol Research Centers should be described along
with a list of joint accomplishments. In addition, for each research
component of the existing Center grant, a succinct account of its
published and unpublished results must be provided, indicating
progress toward achieving aims regardless of whether the component has
been submitted for renewal. More specific details are provided in the
Supplemental Instructions.
Facilities and Environment
Applicants must demonstrate the availability of adequate laboratory,
clinical, and other office facilities needed to carry out the
objectives of the proposed Center program. Although not required, it
is desirable for all Centers to have a commitment for sufficient
contiguous space so that the Center has a high degree of cohesion and
visibility. Reference facilities affording access to relevant
literature must be readily available. It is expected that such
reference facilities will be the primary repository of additional
reference materials that may be obtained through Center funding.
Relevant support services, including adequate data processing
facilities, must also be readily accessible within or through the
institution. Assurances of such support must be included with the
proposal.
Organization and Administration
A Center must be an identifiable organizational unit with an
administrative structure and clear lines of authority which will
facilitate coordination among Center personnel to assure maximum
accountability and efficiency in Center operations. The Director of the
Center will have responsibility for planning and coordination of the
Center program, preparation of the budget and oversight of
expenditures, staff appointments, space allocation, and other aspects
of management and operation of the Center.
Overall program management, coordination, communication, progress
assessment, and quality control are typically responsibilities of the
Director and are facilitated through the administrative core. The
administrative core should be described in sufficient detail to assure
that all proposed components and related activities will function
optimally. In addition, day-to-day operations involving procurement,
finances, personnel, planning, and budgeting should be detailed in the
description of this core.
The applicant may also designate a Scientific Director who will be
responsible to the Center Director and provide direct supervision of
the scientific and operational aspects of the research program. Such a
person should be an individual who has established scientific
credentials and who is capable of providing the leadership essential to
the success of the center program. The Scientific Director will be
responsible for assuring interaction and collaboration among scientists
conducting research within the Center to facilitate a concerted
approach to the research goals of the Center. The Scientific Director
also will be responsible for the direct monitoring of ongoing research
and for identifying (with the assistance of colleagues) research and
educational activities to be expanded or decreased and needs for
additional resources or reallocation of resources. If the Center
Director also serves as the Scientific Director, his or her functions
as Scientific Director should also be described.
Key professional staff, such as directors of individual research
components and core components of the Center, should have the necessary
training/experience to assure that the objectives and goals of the
proposed studies will be achieved. Such persons must be independent
investigators with scientifically recognized standing.
A Program Advisory Committee shall be established and chaired by the
Center Director. Its membership, selected by the Center Director from
individuals outside the Center, should be composed of at least five
members. These members should be persons of recognized scientific
standing who are generally familiar with the Center's activities and
represent a cross-section of disciplines that are relevant to the work
of the proposed Center. It shall be the responsibility of this
Committee to review and make recommendations to the Center Director on
the conduct of all activities of the Center, including the management
of pilot projects. If committees other than the Program Advisory
Committee are included, specific plans regarding committee selection
and function should be provided in the application.
Training
While the primary function of each Center is the conduct of high-
quality interdisciplinary research, an important aspect and related to
the Center and its research efforts is the training of research and
clinical personnel. The applicant institution must therefore
demonstrate or give reasonable assurances that it has:
(a) the capacity to train pre-doctoral and/or postdoctoral students for
careers in alcohol research; and
(b) the capacity to conduct programs of continuing education in the
Center's designated research theme in the medical, behavioral,
epidemiological, or health service fields.
While the Center need not necessarily have formal training programs of
its own, there must be specific provision for coordination between the
Center and the training programs of the applicant institution and/or
affiliated institutions. Center grant funds may not be used to pay
stipends or other trainee costs; however, Center staff may participate
in the development of training programs, and Center resources may be
made available for use of trainees.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
two areas: scientific/research and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Antonio Noronha, Ph.D.
Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane MSC 9304
Room 2055
Bethesda, MD 20892-9304
Telephone: (301) 443-7722
FAX: (301) 443-1650
Email: anoronha@mail.nih.gov
Kathy Salaita, Sc.D.
Division of Epidemiology and Prevention
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane MSC 9304
Room 2078
Bethesda, MD 20892-9304 Telephone: (301) 443-0633
FAX: (301) 443-8614
Email: ksalaita@mail.nih.gov
o Direct your questions about peer review issues to:
Ernestine Vanderveen, Ph.D.
Acting Chief, Scientific Review Branch
Office of Scientific Affairs
ATTN: RFA AA-05-001
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, MSC 9304
Room 3038
Bethesda, MD 20892-9304
Telephone: (301) 443-2531
FAX: (301) 443-6077
Email: tvanderv@mail.nih.gov
o Direct your questions about financial or grants management matters
to:
Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane MSC 9304
Room 3023
Bethesda, MD 20892-9304 Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: jfox@mail.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
Chief, Scientific Review Branch
Office of Scientific Affairs
ATTN: RFA AA-05-001
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, MSC 9304
Room 3038
Bethesda, MD 20892-9304
FAX: (301) 443-6077
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 document is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS
Supplemental instructions for preparing your application may be found
on the NIAAA website at:
http://www.niaaa.nih.gov/extramural/supplemental.htm
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
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)
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research. If so, a letter of agreement from either the GCRC program
director or principal investigator should be included in the
application materials.
At the time of submission, two additional copies of the application and
all copies of the appendix material must be sent to:
Chief, Scientific Review Branch
Office of Scientific Affairs
ATTN: RFA AA-05-001
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, MSC 9304
Room 3038
Bethesda, MD 20892-9304 (Send express or courier deliveries to
Rockville, MD 20852-1705)
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
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.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is, the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes from the previous unfunded
version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by NIAAA. Incomplete and/or nonresponsive
applications will not be reviewed.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIAAA in accordance with the review
criteria stated below. As part of the initial merit review, all
applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the NIAAA National Advisory Council.
REVIEW CRITERIA
The initial review for scientific and technical merit of applications
will emphasize two major aspects: (1) review of the Center as an
integrated research effort focused on a central theme, including the
administrative core; and (2) the review of each research component,
education component, all other core components, and the pilot component
as applicable. This review will also include an assessment of the
academic and physical environment and special considerations, e.g.,
compliance with human subjects and animal welfare requirements, and
compliance with policies concerning inclusion of women, minorities and
children in clinical research study populations.
A) ADMINISTRATIVE CORE
1) Key Staff
o Qualifications, experience, commitment and administrative competence
of the Center Director
o Ability of the Center Director to devote substantial time and effort
to the Center
o Scientific ability of the Scientific Director and his or her
professional experience and leadership
o Scientific qualifications and ability of the directors of the
research components, education components, and core components and
their commitment to the center
2) Arrangements and Organizational Structure
o Processes to facilitate and monitor attainment of Center objectives
o Plans for communication and cooperation among investigators
o Quality control and oversight mechanisms for ongoing projects
o Day-to-day management
o Long-term management and periodic evaluation of goal attainment
o Contractual and consortium arrangements (as applicable)
o Procedures for replacement of key personnel should that become
necessary
B) SCIENTIFIC CORE COMPONENTS
o Need/justification for the core service/resource
o Scientific and technical merit of the service/resource provided
o Plans for resource allocation
o Quality control procedures
o Qualifications, experience, and commitment of the component director
o Adequacy of component director's time and effort
o Adequacy of the resources and environment
C) RESEARCH COMPONENTS
o Significance: Does this study address an important problem? If the
proposed aims are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts
or methods that drive this field?
o Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Does the investigator acknowledge potential
problem areas and consider alternative tactics?
o Innovation: Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
o Investigators: Is each investigator appropriately trained and well-
suited to carry out this work? Is the work proposed appropriate to the
experience level of the component director and other researchers?
(if any)?
o Environment: Does the scientific environment in which the work will
be done contribute to the probability of success of the project? Does
the proposed research take advantage of unique features of the
scientific environment or employ useful collaborative arrangements? Is
there evidence of institutional support?
D) EDUCATION/TRANSLATIONAL COMPONENTS (for P60 applications)
o Significance: Does this project address an important topic? If the
proposed aims are achieved, how will the level of science based
knowledge be enhanced? What will be the effect of these projects on
knowledge, attitudes and behaviors?
o Approach: Are the conceptual framework, design, methods, and
evaluations adequately developed, well-integrated, and appropriate to
the aims of the project? Does the project director acknowledge
potential problem areas and consider alternative tactics?
o Innovation: Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
o Investigators: Is each investigator appropriately trained and well-
suited to carry out this work? Is the work proposed appropriate to the
experience level of the component director and other professional staff
(if any)?
o Environment: Does the environment in which the work will be done
contribute to the probability of success of the project? Does the
proposed project take advantage of unique features of the academic
and community resources and employ useful collaborative arrangements?
Is there evidence of institutional support?
E) PILOT PROJECT COMPONENT
1) Pilot Project Component
o Adequacy of the selection process for new and replacement pilot
projects
o Monitoring and oversight procedures and continuation decisions
o Adequacy of the resources and environment for all projects
2) Individual Pilot Projects
o Importance of topic
o Grounding in the literature or empirical findings
o Reasonableness of the approach
o Potential to develop into full-scale independent project
o Qualifications of the project director
F) CENTER AS AN INTEGRATED WHOLE
1) Significance
o Significance of the overall research goals
o Development of a well-defined central theme
o Multidisciplinary and interdisciplinary scope
2) Coordination and Cohesiveness
o Interrelatedness of administrative core, scientific cores, research
components and education components with each other
o Usefulness of scientific core components to research components and
to independently supported investigators who use them
o Synergistic potential among Center components and core units
o Justification for each research component in terms of the central
theme and the overall research goals of the Center
o Justification for each scientific core component in terms of
accomplishing center objectives
3) Resources and Environment
o Institutional strength, stability, commitment to research, and
support of the Center, including fiscal responsibility and management
capability to assist the Center Director and staff in complying with
DHHS, PHS, and NIH policies
o Opportunities for research training and education for persons from
various disciplines and professions
o Potential for interaction with scientists from other departments and
institutions
o Academic and physical environment in which the research will be
conducted, including availability of space, equipment, research
subjects, and materials
4) Potential as a Resource
o Potential of the Center to become or maintain itself as a regional
and national resource
o Capacity to provide quality research training, opportunities for
independent research career development
o Plans for research information dissemination and educational
activities
5) Renewal Applications
o Degree to which the Center achieved stated goals with special
attention to:
- scientific merit of completed research
- recruitment of new scientists into alcohol research
- development of a multidisciplinary team
- coalescence of Center staff into an effective team
ADDITIONAL Review CONSIDERATIONS
For the Center as a whole and all components/cores. In addition to the
above criteria, in accordance with NIH policy, all applications will
also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will
also be evaluated.
o The reasonableness of the proposed budget and duration of the project
in relation to the proposed research.
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the
research proposed in the application.
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of
the proposed research must include a data-sharing plan in their
application. The reasonableness of the data-sharing plan, or the
rationale for not sharing research data, will be assessed by the
reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or priority score.
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html)
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: November 15, 2004
Application Receipt Date: December 16, 2004
Peer Review Date: April-June 2005
Council Review: September 18, 2005
Earliest Anticipated Start Date: December 1, 2005
AWARD CRITERIA
Center grant funds may be requested for support of core components,
individual research components and education components associated with
the Center program. Administrative core resources may include, for
example, salaries of personnel responsible for management of the
Center, program enrichment activities for investigators and staff such
as special lectures, visiting scientists, symposia, seminars,
workshops, etc., and costs related to dissemination of research
information to the scientific community and lay public. Funds may be
requested for costs associated with individual components that are part
of the Center program. Examples of such costs include: research staff
salaries, supplies, travel, special consultation, research patient
costs, publication costs, and the like. Funds also may be requested
for the allowable indirect costs of the applicant organization. In
addition, costs of advisory committees and consultants may be included
in the administrative core. Consultants for specific components should
be included in the budgets for those components.
Alcohol Research Center grant funds may be used only for costs that are
necessary to carry out the research, research support and education
activities of the Center program, and must be in conformance with HHS
cost principles (encompassed in 45 CFR Part 74) and the NIH Grants
Policy Statement (effective 10/98). This publication should be
available from your office of sponsored research.
Funds provided under this program may not be used for the purchase of
land; nor for the purchase, construction, preservation, or repair of
any building. However, costs of alteration and renovation of existing
facilities necessary to accomplish the objectives of the grant may be
allowed subject to PHS grants policy limitations. Funds provided
through Center grants may not be used for support of trainee stipends,
fees, or other expenses directly related to training activities.
Research, research information dissemination and training activities
associated with the Center may receive additional funding from Federal
sources as well as from State and local sources. The NIAAA expects and
encourages the institution and scientists attracted to such Centers to
seek and compete actively for such funding. Research staff in funded
Centers may submit applications for independent research project grants
for support of research projects that do not overlap with their Center
project(s).
Centers will be required to submit detailed annual progress reports
including substantive information about research results to date,
status of ongoing research, research plans for the next year, and any
modifications in long-term research plans. Also required are reporting
of inventions, reports of expenditures, final reports, and other
reports in accordance with NIH policy.
In view of the special significance of this program, close coordination
and communication between the NIAAA staff and staff of the Alcohol
Research Centers is intended. The NIAAA program official will have
responsibility for maintaining liaison with appropriate Center
leadership, serving as resource consultant to the Center program, and
keeping NIAAA staff informed on progress and accomplishments of the
Centers. In addition, the program official with other NIAAA staff and
consultants will, from time to time, make on-site visits for purposes
of program coordination and exchange of information.
Applications recommended by the National Advisory Council on Alcohol
Abuse and Alcoholism will be considered for funding on the basis of the
overall scientific merit of the application as determined by peer
review, as well as such considerations as program balance, relevance to
the mission and goals of NIAAA, research program priorities, equitable
geographic distribution, continuity of support, and availability of
funds. Awards will be made for up to 5-year project periods with
separate fiscal awards made annually.
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.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required
for all types of clinical trials, including physiologic, toxicity, and
dose-finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risk to
the participants. (NIH Policy for Data and Safety Monitoring, NIH
Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Investigators submitting an NIH application
seeking $500,000 or more in direct costs in any single year are
expected to include a plan for data sharing or state why this is not
possible. (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues
related to institutional policies, local IRB rules, as well as local,
state and Federal laws and regulations, including the Privacy Rule.
Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority
score
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.
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: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement 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://stemcells.nih.gov/index.asp
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, in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. 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).
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 RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic
Assistance, No. 93.891. Awards are made under the authorization of the
Public Health Service Act, Sections 301 and 464J, and administered
under the Federal Regulations at Title 42 CFR Part 549, "Grants for
National Alcohol Research Centers" and 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 PHS strongly encourages all grant 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, 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.
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