RESEARCH PARTNERSHIP AWARDS FOR RAPID RESPONSE TO COLLEGE DRINKING PROBLEMS

RELEASE DATE:  December 18, 2002 
 
RFA: AA-03-008

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov/)

LETTER OF INTENT RECEIPT DATE: March 14, 2003

APPLICATION RECEIPT DATE: April 14, 2003

THIS 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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The purpose of this RFA is to provide a mechanism for developing and 
conducting research which requires rapid funding in order to address 
unexpected and time-sensitive research opportunities to address 
drinking on college campuses.  An over-arching goal is to establish 
ongoing partnerships between college administrators and established 
alcohol research scientists for the purpose of exchanging information, 
and designing interventions to prevent or reduce alcohol-related 
problems among college students.

Applications submitted in response to this RFA should propose research 
plans for innovative and effective interventions, and should 
demonstrate the qualifications of the research personnel and adequacy 
of facilities and resources to achieve the stated goals of the project.  
Study designs should address a hypothetical situation of alcohol abuse 
and/or associated problems among college students, and propose 
practical solutions and interventions that can be implemented 
immediately.  Study designs may propose interventions focused at the 
individual, campus, or community levels.

Grantees funded under this RFA U01 program will be coupled with one (or 
possibly more) grantees funded under the companion U18 RAPID response 
program announcement to form a performance unit for the purposes of 
implementing one or more of the final protocols. They may receive 
suggestions for the strengthening of approaches under study.  Together 
they will develop final study designs.  

Award of the cooperative agreement does not imply that any particular 
proposed protocol will be implemented.  Since the final studies will be 
designed by the Steering Committees, each of which is composed of a 
research awardee, a partnered service awardee, and the NIAAA Staff 
Collaborator, the final protocols may not reflect any single protocol 
submitted in response to this RFA.  The protocols will be implemented 
as needed, at time(s) and site(s) to be determined by the Steering 
Committee.  Not all awards will commence at the same time.

RESEARCH OBJECTIVES
 
Alcohol use on college campuses is not a new problem; it has been 
documented in the United States for at least 50 years.  Available 
research indicates that approximately 80 percent of college students 
drink and that half of college student drinkers engage in heavy 
episodic drinking.  Excessive drinking among college students is 
associated with a variety of negative consequences including fatal and 
nonfatal injuries; alcohol poisoning; blackouts; academic failure; 
violence, including rape and assault; unintended pregnancy; sexually 
transmitted diseases, including HIV/AIDS; property damage; and 
vocational and criminal consequences that could jeopardize future job 
prospects.

The consequences of excessive and underage drinking affect virtually 
all college campuses, college communication, and college students, 
whether they choose to drink or not.  It is estimated that 1,400 
college students die each year from alcohol-related unintentional 
injuries, including motor vehicle crashes. The estimates include a half 
million students injured and more than 600,000 alcohol related 
assaults, Other problems include sexual abuse, unsafe sex, academic 
problems, suicide attempts, vandalism, property damage, drunk driving 
and police involvement.   These potential fatal and devastating 
problems do not address the needs of non-alcohol consuming students who 
must suffer the consequences (interrupted sleep, assaults, riding in 
automobiles with intoxicated drivers, etc.) related to the behavior of 
their peers.

Over the past 10 to 15 years, colleges and universities have addressed 
the problem of underage and "binge" drinking in a variety of ways.   
Preventive interventions have been implemented in response to: policy 
directives from the U.S. Department of Education, administrator and 
faculty concerns about alcohol problems on their campuses, and 
community reactions to nationally publicized alcohol-related deaths 
among college students.  However, rigorous studies of the effectiveness 
of these naturally occurring policies and initiatives have been rare, 
as have studies of investigator-initiated interventions that focus 
on changing campus environments as a means of preventing alcohol 
problems.  

With rare exceptions, scientifically-grounded research on strategies to 
prevent college-based alcohol abuse has focused on so-called 
"individual" interventions, such as motivational counseling for high-
risk students and groups, or approaches that challenge positive 
expectancies (beliefs) about the benefits of alcohol use.  These types 
of interventions seek to change individuals' knowledge, attitudes, 
intentions, and skills regarding alcohol use, without attempting to 
change factors in the environment which facilitate and promote alcohol 
misuse.  

Survey data indicate that environmental factors play a major role in 
promoting and supporting excessive drinking among college students.  
Campuses differ significantly in the amount of "binge" drinking that 
takes place, suggesting that more than selective factors are at work.   
For example, lower levels of "binge" drinking are found among students 
who attend "commuter" colleges where most students live off-campus.   
Students who live at home drink less than those who live in apartments 
or dormitories; and students who live alone drink less than those with 
roommates.  This type of information can help inform the choice of 
target groups for interventions and aspects of their design.  

Environmental interventions (particularly laws and policies that target 
youth) have demonstrated effectiveness in reducing drinking and related 
problems in the underage population at large.  Therefore, it has been 
argued that these types of interventions (constraining the availability 
of alcohol, enhancing enforcement of existing policies) have the 
potential to reduce alcohol problems among college students.  For 
example, it has been found that the restrictiveness of State drunk-
driving laws that target youth and young adults appears to be inversely 
related to measures of college-student drinking, especially for males.  
It has also been found that the number of alcohol outlets within one 
mile of campus and the presence of a bar on campus correlated 
positively with levels of drinking and "binge" drinking on campus.   

The interventions being tested may involve changes in campus or 
community policies and practices to directly address factors 
contributing to abusive drinking, or they may involve changes in campus 
systems or structures to promote non-drinking norms.  Multi-component 
interventions may be tested that combine environmental strategies or 
link them with interventions that focus on individuals.  For example, 
the institution of new policies or changes in policy enforcement might 
be combined with interventions that target high-risk students.  The 
selection of interventions for study should be justified in terms of 
their potential impact on specific alcohol problems, adverse drinking 
practices, high-risk populations, and/or permissive social norms.  In 
addition, the feasibility of implementing the intervention should be 
discussed, as well as its generalizability, even where the choice of 
interventions is beyond the investigator's control (i.e., natural 
experiments). 

In recognition of the need to address the serious consequences of 
alcohol abuse among college students, the National Advisory Council to 
the National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
established the Task Force on College Drinking in 1998.  The Task Force 
was composed of college Presidents and administrators as well as 
selected experts in alcohol research. In April, 2002 a report entitled, 
A Call to Action: Changing the Culture of Drinking at U.S. Colleges, 
was released and is available on the NIAAA webpage: 
www.collegedrinkingprevention.gov. The report supported the use of 
comprehensive integrated programs with multiple complementary 
components that target (1) individuals, including at-risk or problem 
drinkers; (2) the student population as a whole; and (3) the college 
and the surrounding community.

This announcement is intended to provide an opportunity for 
investigators to identify an approach that might be appropriate given 
this unique environment and circumstances and to design and perform one 
or more studies of intervention or prevention with regard to college 
drinking.  It is understood that each college environment and student 
community is different. Differences in ethnic mix, rural vs. urban, 
private vs. public, etc. can result in different approaches to 
appropriate interventions.

Although this announcement is designed to support research on 
unanticipated opportunities, the following are some of the areas in 
which research plans might be developed.  These are in no way meant to 
be exhaustive or limiting, but mere examples of topics that might be 
studied.  Such topics might include: 

- The implementation and evaluation of a program of alcohol screening 
and brief interventions 

- Changes in campus or community policies and practices to directly 
address factors contributing to abusive drinking, or they may involve 
changes in campus systems or structures to promote non-drinking norms.

- Policies and practices of campus health-care systems and providers 
with regard to alcohol abuse;

- Policies directed toward high risk groups, such as athletes or 
students in the Greek system;

- Emergency action plans by campus administrators in response to 
adverse alcohol-related injuries and deaths;

- The academic environment, including class and examination schedules 
and academic standards;

- Campus policies, such as rules and administrative proclamations 
regarding alcohol use on campus, in dormitories, and at campus events;

- Disciplinary procedures, such as parental notification, mandatory 
counseling, and other sanctions for rule violations;

- Planning and conducting marketing campaigns aimed at correcting 
student misperceptions about alcohol use; 

- The formation of a campus and community coalition consisting of 
community leaders and law enforcement to directly address the problem 
of student drinking.

Outline of Study Design
 
To address the research questions of this program, the application 
should include, at a minimum, the following major components:

o   The study design should address a hypothetical situation of 
alcohol abuse and/or associated problems among college students.

o   The study design should propose practical solutions and 
interventions that can be implemented immediately.

o   The study design may propose interventions focused on the 
individual, campus, or community levels.

o   Duration of the intervention should be at least 6 months and 
minimum follow-up should be at least 1 year.

o   Specific hypotheses for preliminary study, design, and assessment 
are left to the discretion and creativity of the applicants. 

Elaboration of the Model Study Design
 
Although the outline of a model strategy is given above, applicants 
should develop and fully elaborate the key elements of the study 
design. 

Final Protocol Development
 
After awards are made, the Steering Committees will collaboratively 
develop potential study protocols that may differ from the model 
outlined here, provided the research questions of this RFA are 
addressed and the Institute agrees that the resultant design is still 
within the general scope and will serve the purposes described in this 
RFA.  Each Steering Committee will consist of a research U01 awardee, a 
partnered service U18 awardee, and the NIAAA Staff Collaborator.  
Applicants should request funds to attend two meetings in the 
Washington, D.C. area per year.
 
Consultant Services

Applications should include provisions for consultancy to college 
presidents and other administrators in the design of specific 
prevention activities to be studied. Consultants are individuals who 
will be available in emergency situations to provide assistance in 
planning and implementation.  Consultants should be recognized experts 
in alcohol research. The consultants must agree to work with College 
Presidents when asked by NIAAA Project Officer.  The budget allowable 
for a consultancy is a maximum of two modules ($50,000). 

Pilot and Feasibility Studies

Each application should have provisions for Pilot Studies, Feasibility 
Studies, or a combination of the two.  They are described more fully 
below.  These projects may be implemented prior to, or after partnering 
with a University Administrator (service partner) under PA –XXX.

Pilot Studies

A pilot study is a short term study of 2 semesters or 1 year total 
length of time. The maximum budget allowed for a pilot study is two 
modules ($50,000). The pilot project can provide a flexible means to 
develop and explore a particular activity or direction prior to being 
partnered, or at the initial stage of partnering, with a service 
partner (college president).  The goals of a pilot study are short-term 
and easily accomplished within the allowable timeframe.

Feasibility Studies

A feasibility study is a short term study of 1 semester or 6 months 
total length of time.  The maximum budget allowed for a feasibility 
study is one module ($25,000).  The feasibility project can provide a 
flexible means to develop and explore a particular activity or 
direction prior to being partnered, or at the initial stage of 
partnering, with a service partner (college president).  The goals of a 
feasibility study are more modest than for a pilot study, and easily 
accomplished within the allowable timeframe.

MECHANISM OF SUPPORT

This RFA will use the NIH U01 award mechanism.  As the research 
applicant you will be responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation.  
Future unsolicited, competing-continuation applications based on this 
project will compete with all investigator-initiated applications and 
will be reviewed according to the customary peer review procedures.  
The anticipated award date is September 29, 2003.

This RFA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular format.  Otherwise 
follow the instructions for non-modular research grant applications.
The NIH (U01) is a cooperative agreement award mechanism in which the 
Principal Investigator retains the primary responsibility and dominant 
role for planning, directing, and executing the proposed project, with 
NIH staff being substantially involved as a partner with the Principal 
Investigator, as described under the section "Cooperative Agreement 
Terms and Conditions of Award."  
FUNDS AVAILABLE 
 
The NIAAA intends to commit approximately $4 million in FY 2003 to fund 
1 to 5 new grants in response to this RFA. An applicant may request a 
project period of up to 5 years and a budget for direct costs of up to 
$500,000 per year. 

Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size and 
duration of each award will also vary.

As the level of research activity is expected to increase when awardees 
under this RFA partner with University Administrators (service partner) 
awarded under PA-XXX, applications may not be fully funded at the 
outset.  The remaining award will become available as projects are 
implemented.

Although the financial plans of NIAAA provide support for this program, 
awards pursuant to this RFA are contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious 
applications. 

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
o Faith-based or community-based organizations 
 
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.   
 
SPECIAL REQUIREMENTS

The application should include a proposed protocol that meets the
objectives and scope outlined in this RFA and responds to the
required major components as stated in the "Research Questions" and
"Study Design" sections.  

The application should indicate the key professional personnel who will 
serve as consultants and provide advice/assistance to 
college/university administrators, when requested by NIAAA.

The applications should include plans for pilot and/or feasibility 
studies that can be undertaken at a designated college/university 
research site when requested.  Such studies may be undertaken in 
conjunction with a RAPID award to college/university administrators, as 
described in the companion program announcement.

The applications should include budgetary allowance for attendance at 
two mandatory meetings per year.  These meetings of all awardees under 
this RFA and those under the RAPID PA XXX will be held at approximately 
6-month intervals in the Washington, D.C. area.

Award of the cooperative agreement does not imply that any particular 
proposed protocol will be implemented.  Since the final study will be 
designed by a Steering Committee of the investigators of at least one 
research award (U01) and one service award (U18), the final protocol 
may not reflect the research plan submitted by the applicant in 
response to this RFA.

COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD
 
The following terms and conditions will be incorporated into the award 
statement and provided to the Principal Investigator(s) as well as the 
institutional official at the time of award.  These special Terms of 
Award are in addition to and not in lieu of otherwise applicable OMB 
administrative guidelines, HHS Grant Administration Regulations at 45 
CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration 
policy statements.
 
The administrative and funding instrument used for this program is a 
clinical research cooperative agreement (U01), an "assistance" 
mechanism (rather than an "acquisition" mechanism) in which substantial 
NIH scientific and/or programmatic involvement with the awardee is 
anticipated during performance of the activity. Under the cooperative 
agreement, the NIH purpose is to support and/or stimulate the 
recipient's activity by involvement in and otherwise working jointly 
with the award recipient in a partner role, but it is not to assume 
direction, prime responsibility, or a dominant role in the activity.
 
Consistent with this concept, the dominant role and prime 
responsibility for the activity resides with the awardee(s) for the 
project as a whole, although specific tasks and activities in carrying 
out the studies will be shared among the awardees and the NIAAA project 
staff. The NIAAA is not to assume direction, prime responsibility, or a 
dominant role in the activities. Details of the roles of the parties 
are described later in this section.
 
A. Principal Investigator Rights and Responsibilities
 
Principal Investigators will have primary and lead responsibilities for 
the project as a whole including participant recruitment and follow-up, 
data collection, quality control, interim data and safety monitoring, 
final data analysis and interpretation, preparation of publications, as 
well as collaboration with other awardees and with assistance from 
NIAAA staff.
 
The Principal Investigator defines the details for the project in
accordance with these Terms and Conditions of Award; retains primary
responsibility for the performance of the activity; and agrees to
close coordination, cooperation, and assistance of NIAAA extramural
staff in aspects of scientific and technical management of the
project as described herein.
 
Each Principal Investigator (or designee) is responsible for
attending all Steering Committee meetings.  The Steering Committee 
shall be responsible for determining the frequency and scheduling of 
meetings.  Each Principal Investigator (or designee) will be expected 
to participate in all other Steering Committee activities, e.g., 
conference calls, special subcommittees as may be necessary, etc.

Each Principal Investigator is responsible for obtaining local 
institutional review board (IRB) approval of all study protocols 
implemented at U.S. or foreign sites and comply with both IRB and 
Steering Committee policies and procedures.

Each Principal Investigator is responsible for collaborating with the 
designated service partner(s) and other member(s) of the Steering 
Committee.

Each Principal Investigator is expected to publish and disseminate 
results of both independent and shared research.  When joint protocols 
are competed, publish in collaboration with other involved site(s).
 
Each awardee institution and its corresponding investigators will be 
responsible for developing and implementing research aims; adjusting 
research priorities in accordance with current developments and 
available budget funds; participating in analyses; and accepting the 
participatory and cooperative nature of the group process and policies 
relevant to this program.

Each Principal Investigator is expected to be responsible for 
contracting with consultants to the Steering Committee on an as needed 
basis.
 
B. NIAAA Staff Responsibilities
 
The NIAAA staff role in this cooperative agreement will extend beyond 
the level normally required for stewardship of a grant because of the 
need for coordination of study protocols among performance sites, 
technical assistance in the analysis of data, and monitoring and 
possible reassessment of project objectives as the study proceeds. The 
NIAAA extramural staff perform different functions in research projects 
supported under the cooperative agreement mechanism.
 
1. Program Official
 
The Program Official provides normal stewardship of the award and has 
overall responsibility for monitoring the conduct, progress, and fiscal 
management of the program.  Progress of the project will be reviewed by 
the Program Official annually at the time of each continuation 
application to assure that satisfactory progress is being made in 
achieving the objectives of the project and that each performance site 
is following the program goals and procedures recommended for use by 
all participants in the cooperative program and approved by the 
Steering Committee.
 
2. NIAAA Staff Collaborator
 
The NIAAA Staff Collaborator has substantial scientific input in 
collaboration with award recipients, in both planning and conduct of 
the research.  The NIAAA Staff Collaborator will: 
1)  participate as a voting member on each Steering Committee 
which oversees each collaborative research effort, and 
relevant technical subcommittees or working groups as 
appropriate; 
2)  participate in the formulation of protocols and other 
planning related to the completion of the research;
3)  participate in pairing of research and service award 
partners;
4)  participate in monitoring the progress of the research and 
quality control; and
5)  participate in the analysis and interpretation of data, and 
possibly in associated publications and presentations.

C. Collaborative Responsibilities
 
1. Steering Committee
 
A Steering Committee will be the main governing unit of each study and 
will have primary responsibility for all decisions. Each Steering 
Committee will be composed of a Principal Investigator (or designees) 
of the U01 research award, the partnered Service Awardee (U18) and the 
NIAAA Staff Collaborator.  Each will have one vote, should a vote of 
the Steering Committee be necessary to make a decision.  The functions 
of each Steering Committee include: defining protocol objectives and 
approaches; designing and implementing the protocol; developing 
procedures for data collection and management and quality control; 
establishing procedures for assessing performance; analyzing and 
interpreting study data; and publishing/presenting study findings. 

D. Monitoring Study Progress
 
The Data and Safety Monitoring Board (DSMB) is an independent board of 
experts established by the NIAAA which oversees the integrity of data 
and safety of clients. The Institute convenes the DSMB once a year.  
Its major function is to review reports of subject safety and data 
integrity on a regular basis. The Board is also responsible for 
reviewing and approving the final protocol prior to the start of the 
recruitment phase, and for approving the progression from one phase of 
the trial to the next.
 
E. Arbitration
 
Any disagreement that may arise on scientific/programmatic matters 
(within the scope of the award), between award recipients and the
NIAAA may be brought to arbitration.  An arbitration panel will be
composed of three members; one selected by the Steering Committee
(with the NIAAA member not voting) or by the individual awardee in
the event of an individual disagreement, a second member selected by
NIAAA, and the third member selected by the two prior selected
members. This special arbitration procedure in no way affects the
awardee's right to appeal an adverse action that is otherwise
appealable in accordance with the PHS regulations at 42 CFR Part 50,
Subpart D and HHS regulation at 45 CFR Part 16.

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:

Peggy Murray 
Director, International Research and Training Program
Office of Collaborative Research 
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 302
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 443-2594
FAX: (301) 480-2358
Email: pmurray@mail.nih.gov

o Direct your questions about financial or grants management matters 
to:

Judy Fox 
Chief, Grants Management Branch
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
(301) 443-4704 (telephone)
(301) 443-3891 (fax)
email:  jsimons@willco.niaaa.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:

RFA-AA-03-008
Extramural Project Review Branch 
National Institute on Alcohol Abuse and Alcoholism 
6000 Executive Boulevard, Room 409, MSC 7003 
Bethesda, MD 20892-7003 
Rockville, MD 20852 (for express/courier service) 
Telephone: (301) 443-4375
FAX: (301) 443-6077 

by the letter of intent receipt date listed.

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
 
Additional Materials to Include in the Application
 
1.  All costs required for the proposed protocol must be included in 
the application and must be fully justified.  Requested budgets should 
include travel to the Washington, D.C. area for two 2 day Steering 
Committee meetings each year during the duration of the trial, except 
for the first year when three meetings may be required.  In addition, 
budgets should include travel to the Washington, D.C. area for two 
meetings per year that include all of the awardees. 
 
2. The application should discuss the capability of the applicant 
organization to participate and interact effectively in multi-center 
research projects.
 
3. The application must include a written commitment to accept the 
participation and assistance of NIAAA staff in accordance with the 
guidelines outlined under "NIAAA Staff Responsibilities" as stated 
above.  The application must also include a written commitment to the 
cooperative organization and willingness to serve on the Steering
Committee and adhere to the decisions reached by that Committee, 
including following a consensus protocol.
 
4. The application must name a single Principal Investigator (PI) who 
will have scientific responsibility for the application as a whole 
including all research activities included under it.  Applications from 
a consortium of institutions must name a single Senior Investigator for 
each participating institution (other than the applicant institution) 
who will be responsible for on-site scientific direction and 
implementation for the consensus protocol.  Senior Investigators in 
consortia must also document relevant experience in alcoholism 
prevention research.
 
5. The application must provide a clear, concise plan showing the 
scientific discipline of the PI and of all key scientific, technical 
and administrative personnel, and a mechanism for replacing key 
professional or technical personnel should the need arise.

6. Allowable costs.  The total direct costs allowed for any application 
will be up to $500,000 per year for up to 5 years.  Up to $50,000 per 
year will be allowed to support the costs of the consultant services to 
advise and assist the college/university administrators.  Pilot studies 
are expected to cost up to $50,000 per year for one year.  Feasibility 
studies are typically expected to cost up to $25,000 per year for one 
year. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.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)
 
At the time of submission, two additional copies of the application 
must be sent to:

RFA-AA-03-008
Extramural Project Review Branch 
National Institute on Alcohol Abuse and Alcoholism 
6000 Executive Boulevard, Room 409, MSC 7003 
Bethesda, MD 20892-7003 
Rockville, MD 20852 (for express/courier service) 
Telephone: (301) 443-4375
FAX: (301) 443-6077 

APPLICATION PROCESSING: Applications must be received by 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.
 
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.  The CSR will not accept any application that is 
essentially the same as one already reviewed. This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing 
the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the (IC).  Incomplete and/or non-responsive 
applications will be returned to the applicant without further 
consideration.

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 (IC) in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Receive a written critique
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 second level review by the NIAAA National Advisory Council. 
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the 
following aspects of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
   
   The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your application does not need to 
be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, 
you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the 
aims of your application are achieved, how do they advance scientific 
knowledge?  What will be the effect of these studies on the concepts or 
methods that drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Do you acknowledge potential problem areas and 
consider alternative tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project 
challenge existing paradigms or develop new methodologies or 
technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to your 
experience level as the principal investigator and to that of other 
researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work 
will be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application.

o INCLUSION:  The adequacy of plans to include subjects from both 
genders, all racial and ethnic groups (and subgroups), and children as 
appropriate for the scientific goals of the research.  Plans for the 
recruitment and retention of subjects will also be evaluated. (See 
Inclusion Criteria included in the section on Federal Citations, below)

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

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

o OTHER REVIEW CRITERIA
- Clearly discernible research design, involving generation and/or 
testing of hypotheses
- Rationale for the proposed methodology
- Feasibility and timeliness of the proposed research
- Availability of adequate facilities and resources necessary for the 
research
- Qualifications of the research personnel

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: March 14, 2003 
Application Receipt Date: April 14, 2003
Peer Review Date: June-July 2003
Council Review: September 17, 2003
Earliest Anticipated Start Date: September 29, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

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

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

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

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

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

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: 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.

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.

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, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 
USC 241 and 284)and administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

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

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