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) 435-0714, 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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