DEVELOPING ALCOHOL-RELATED HIV PREVENTIVE INTERVENTIONS

Release Date:  October 11, 2001

RFA:  RFA-AA-02-003

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

Letter of Intent Receipt Date:  December 28, 2001
Application Receipt Date:       January 23, 2002

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS 
THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED 
IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to 
stimulate the design, development, and testing of alcohol-related HIV 
preventive interventions that have the potential for reducing the risk of 
transmission of HIV in alcohol using, abusing, and dependent populations.  
This Request for Applications (RFA) is responsive to a proposed HIV 
Prevention Science Initiative by the Office of AIDS Research that seeks to 
stimulate further research on the impact of "... early identification (of HIV 
infection), counseling, and other behavioral interventions, and HIV treatment 
on risk behaviors, the utilization of HIV prevention services, and the 
transmission of HIV."  It also advances the mission of the NIAAA Office of 
Collaborative Research, which includes the promotion and coordination of 
trans-Institute collaborative programs related to HIV/AIDS and other 
illnesses which disproportionately affect minority populations.  The focus of 
this priority area is on intervening to change alcohol-related behavior of 
HIV-infected individuals as it relates to further transmission of HIV between 
individuals and diminished health outcomes among those infected. Because 
these risk behaviors occur in the context of drinking situations, drinking 
networks, and “wet” communities, the interplay between these 
social/environmental factors and individual level factors is of particular 
interest with regard to potential targets for intervention. A commitment to 
multidisciplinary, collaborative research, and to research that focuses on a 
range of population groups that combine alcohol and HIV/AIDS risks is 
implicit in this priority.

Investigators are encouraged to move beyond basic behavioral studies to 
implement a continuum (from efficacy to effectiveness) of substance use risk-
reduction interventions in populations at risk for both alcohol problems and 
HIV infection. This RFA on prevention research in the alcohol/AIDS area 
continues the previous focus of the NIAAA Prevention Research Branch on 
primary prevention of HIV and alcohol abuse among male and female alcohol 
users. However, A new emphasis on collaborative approaches between 
researchers and communities for translating prevention research to practice 
in community settings has also been identified. In addition, this RFA 
addresses secondary prevention issues (including alcohol treatment and risk 
reduction) among HIV infected male and female alcoholics who may be more 
likely than other HIV infected individuals to engage in high-risk sexual 
behavior, to use unclean needles, and to have problems adhering to 
therapeutic treatments for HIV and AIDS.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2000," a PHS-
led national activity for setting priority areas.  This RFA is related to the 
priority area of AIDS prevention.  Potential applicants may obtain a copy of 
"Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary 
Report:  Stock No.017-001-00473-1) through the Superintendent of Documents, 
Government Printing Office, Washington, DC 20402-9325 (Telephone: 202-512-
1800).

ELIGIBILITY

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

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project 
grant (R01) and the NIAAA exploratory/developmental (R21) award mechanism.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The total project period for a 
research project grant (R01) application submitted in response to this RFA 
may not exceed 5 years. Exploratory/developmental grants (R21) are limited to 
3 years for up to $100,000/year for direct costs. (See Program Announcement 
PA-99-131, “NIAAA Exploratory/Developmental Grant Program,” 
http://grants.nih.gov/grants/guide/pa-files/PA-99-131.html, for a complete 
description of the R21 mechanism.)

Applicants are also encouraged to submit applications for Investigator-
Initiated Interactive Research Project Grants (IRPG) which is available at 
http://grants.nih.gov/grants/guide/pa-files/PA-96-001.html.  The IRPG 
mechanism requires the coordinated submission of related research project 
grants (R01) from investigators who wish to collaborate on research, but do 
not require extensive shared physical resources.  These applications must 
share a common theme and describe the objectives and scientific importance of 
the interchange of, for example, ideas, data, and materials among the 
collaborating investigators.  A minimum of two independent investigators with 
related research objectives may submit concurrent, collaborative, cross-
referenced individual R01 applications.  Applicants may be from one or 
several institutions.

This RFA is a one-time solicitation.  Future unsolicited competing 
continuation applications will compete with all investigator-initiated 
applications and be reviewed according to the customary peer review 
procedures.  The anticipated award date is July 1, 2002.

FUNDS AVAILABLE

It is estimated that up to $3.0 million will be available to fund 
approximately 10 to 15 grants under this RFA.  This level of support is 
dependent on the receipt of a sufficient number of applications of high 
scientific merit.  The award of grants pursuant to this RFA is contingent 
upon the availability of funds for this purpose.

RESEARCH OBJECTIVES

Alcohol consumption has been identified as an important behavioral cofactor 
for HIV infection and has been consistently associated with HIV-risk 
behaviors over time. Significantly higher rates of HIV infection are found 
among clinical samples of male and female alcoholics and nonclinical samples 
of individuals who meet criteria for alcohol dependence than in the general 
public. In addition, reduction in alcohol use in treatment samples is 
associated with reduced sexual risk taking. Higher levels of alcohol use has 
also been shown to predict higher incidence of infection and reduced time to 
seroconversion among gay men, and non-adherence to medical regimens among 
infected individuals. Although, there is limited research among minority and 
impoverished women who are at increasing risk for HIV infection, alcohol use 
by women and their partners has been linked to increased sexual violence and 
susceptibility to HIV infection.  Alcohol-related HIV interventions are being 
tested among gay and bisexual men, Native American youth, incarcerated young 
adults, and persons in alcoholism treatment. Initial results after 
intervention and at follow-up suggest that a wide range of HIV-risk behaviors 
can be reduced, particularly among gay men and in alcohol treatment contexts. 
This research suggests that substance abuse prevention and treatment programs 
that include HIV components are more effective in reducing alcohol 
consumption and risky sexual practice than those that do not contain these 
components.  Similarly, it appears that HIV prevention programs that include 
an alcohol risk-reduction component may be more effective in reducing HIV 
risk behaviors than those that do not.

Preventive interventions may be initiated and implemented by the 
investigators themselves for the specific purpose of testing effects of the 
strategies; or the interventions may occur naturally through the actions of 
public and private organizations (e.g., reduction in availability and 
accessibility of alcohol, increased distribution of condoms at bars, health 
promotion campaigns that highlight linkages between alcohol use and AIDS).  
Investigator-initiated alcohol-focused interventions may also be nested 
within the context of naturally occurring HIV interventions, such as vaccine 
trials, permitting the effects of both types of interventions to be studied 
simultaneously.  These alcohol-focused interventions can be aimed at 
individuals, social networks, institutions, and specific alcohol settings 
such as bars and clubs, to change alcohol-related sexual expectancies, 
behavioral norms, and HIV risk-taking behaviors.  Populations at risk for HIV 
who also abuse or are dependent on alcohol are most in need of study.  These 
special subgroups include alcohol abusing women and minorities, gay or 
bisexual men, male and female alcoholics in treatment, and adolescents 
initiating sexual behavior in the context of drinking networks, in which HIV 
is prevalent.  Other groups of interest that may be indirectly affected by 
alcohol use include partners and families of HIV-infected alcoholics.

In addition to developing and testing new investigator-initiated 
interventions or measuring effects of naturally-occurring preventive policies 
or programs, timely and cost-effective approaches may include:

a) developing additional HIV interventions within the context of clinical 
studies to address alcohol-related problems (e.g., improving adherence of 
alcohol abusers to therapeutic regimens involving antiretrovirals, 
microbicides, vaccines, etc).

b) augmenting ongoing alcohol-problem intervention studies to include HIV
infected or at-risk populations and adapting the intervention to address HIV
issues in this subgroup (e.g., including HIV-risk populations in comparisons 
of brief motivational counseling and cognitive-behavioral interventions).

Several areas of emphasis for particular high-risk groups or innovative
approaches to multidisciplinary research may be appropriate for proposed
intervention studies.  These include, but are not limited to:

Collaborative Community-Based Research:  As behavioral researchers focus on
problems of substance abuse and AIDS they are increasingly involved in the
communities that are most affected. Urban ethnic and racial minority
neighborhoods are particularly affected and often hard to access. To overcome
barriers to access, behavioral scientists have formed productive 
collaborative alliances with organizations within these community 
environments, including non-government organizations (NGOs). In the case of 
this RFA, researchers and NGOs are encouraged to collaborate in developing 
and testing interventions for alcohol abuse and HIV problems. Where 
appropriate, proposed community-based research should provide support for 
researchers within the NGO, to promote joint participation in a scientific 
knowledge-building process. Effective collaborative relationships should 
facilitate rigorous scientific evaluation of intervention outcomes. Suggested 
areas of research include but are not limited to:

- studies that develop and test different modes for transferring effective 
research-based Alcohol/HIV prevention interventions into ethnically diverse 
communities.

- studies of mechanisms that would enable community-based organizations to 
advise and communicate with the research community on needed research to 
improve responses to ongoing or emerging alcohol-related HIV public health 
issues.

- studies which identify and evaluate outcome measures appropriate to the 
evaluation of research-based alcohol/HIV prevention interventions implemented 
in community settings.

- research on the characteristics of community-based organizations and 
coalitions most likely to be successful in implementing research-based 
prevention interventions in at-risk communities.

- develop and validate effective models for the translation of research-based 
alcohol/HIV prevention interventions into the community.

- studies of the cost-effectiveness of research-based alcohol/HIV prevention 
interventions when implemented in different health and community settings.

Medically Underserved Populations Including Women and Families:  Alcohol 
abusers often delay entering medical settings where they could be identified 
as needing appropriate interventions and are often difficult to retain in 
controlled clinical trials. Such difficulties in attracting and retaining 
alcohol-abusing individuals may have particular significance for the testing 
and evaluation of HIV vaccines and therapeutics.  In addition, alcohol may be 
a primary substance of abuse by those with multiple co-occuring psychiatric 
and AIDS-related medical diagnoses. New interventions need to be developed to 
attract and retain these individuals at extremely high-risk for negative 
health outcomes, and new research designs and analytic strategies need to be 
developed to adequately evaluate these interventions in settings in which 
high rates of attrition may occur.  Intervention strategies may include, for 
example, more informal and culturally relevant drop-in clinics. Another 
approach may include the development of different research procedures, such 
as case-control or case-based designs which may be necessary to test the 
effects of these interventions on such variables as HIV exposure, 
interactions with alcohol abuse, and disease outcomes.  In recent years there 
have been significant advances in our understanding of the ways in which the 
causes and consequences of alcohol misuse differ in men and women.  However, 
much remains to be learned about how those differences impact HIV 
transmission, disease progression and clinical outcomes. Research efforts are 
needed develop alcohol/AIDS interventions to:

- develop methods to promote routine screening of women and other under 
served individuals for alcohol misuse, high risk sexual practices, and other 
HIV risk behaviors in health care settings

- enhance understanding of the impact of coexisting alcohol use disorders and 
HIV/AIDS on families, particularly single parent families; 

- measure the combined impact of treatment for alcohol use disorders and 
HIV/AIDS on vertical transmission of HIV and on other pregnancy outcomes 
(e.g. SIDS, premature birth)  

- improve linkage of general medical services, alcohol and other substance 
abuse treatment, and reproductive health services 

- enhance medical communication strategies between treatment providers to 
improve care of groups at highest risk for alcohol abuse and HIV-infection, 
which include impoverished youth and women, selected ethnic minorities, gay 
and bisexual men, and male and female partners of HIV-infected individuals.

Community-based Institutional Approaches to Improving HIV and Alcohol Abuse 
Prevention:  Community-level activities are critically important components 
of the national strategy to prevent alcohol and other drug (AOD) abuse and 
HIV infection. When community institutions are involved in AOD and HIV 
prevention, they may engage in activities such as providing educational 
intervention, distributing condoms, sponsoring community outreach activities 
such as street ministries or public awareness campaigns, or coordinating with 
other community organizations in service-delivery or fund-raising activities.  
Despite the impressive involvement of many community institutions in 
prevention activities, little research exists that systematically examines 
the diverse ways in which these organizations can contribute to HIV 
prevention and the factors that make them effective or ineffective in doing 
so.  This initiative seeks to build a body of social science knowledge that 
will lead to innovative and effective approaches to preventing alcohol and 
other drug (AOD) misuse and HIV by expanding thinking on how community 
institutions affect risk and prevention of AOD abuse and HIV infection. For 
the purposes of this initiative, an institution is defined as a formal 
organization that is located in a community, engaged with community 
residents, and focused around a mission or activity.  Examples of community 
institutions include churches, grocery stores, schools, and voluntary 
associations.  Important research objectives regarding the role of community 
organizations and coalitions in the prevention of AOD and HIV/AIDS include, 
but are not limited to:

- engaging community institutions to effectively reach out to HIV-positive 
and at-risk individuals and to implement effective prevention interventions?  
Promoting linkage between prevention and health care services;

- improving mechanisms through which community institutions influence health 
and well being, generally, and health behaviors and AOD and HIV risk and 
protection specifically;

- improving the effectiveness of institutions in shaping and enforcing 
community norms relevant to HIV and AOD risk.  Promoting understanding of how 
the influence of institutions differs by type, structure of institution, 
relationships among institutions, and community context;

- identifying and reinforcing characteristics of institutional norms, 
structure, operation, and activities which are associated with effective AOD 
and HIV prevention in particular communities and settings;

- changing organizational environments and facilitating the implementation of 
research-based HIV prevention interventions;

- using new technologies to inform, train and assist community-based 
organizations to implement and sustain efficacious AOD and HIV prevention 
interventions;  Such new technologies may include use of the internet, CD-
ROMS or other potentially cost-effective modalities.

HIV/AIDS and Alcohol Use Among Adolescents: In contrast to the attenuation of 
the infant AIDS epidemic in the United States, there is evidence that HIV 
infection rates are increasing tin the adolescent population.  This expanding 
adolescent HIV epidemic is increasingly female, minority, and related to 
sexual transmission (i.e., heterosexual activity in females and homosexual 
activity in males).  Use of alcohol and illicit drugs by youth is related to 
early sexual experience.  These risky behaviors may lead to unprotected 
sexual intercourse and are related to the acquisition and transmission of HIV 
among adolescents.  Certain sub-populations of adolescents, in addition to 
females and minorities, are particularly at high risk for HIV infection.  
Examples are homeless, runaway, and street youth who engage in unsafe sex as 
a means of obtaining drugs or money, especially in urban area with high HIV 
rates, adolescents in juvenile detention centers where there is frequent HIV-
associated risk-taking behavior, and alcohol and other drug-using adolescents 
in rural communities with increasing HIV seroprevalence. Within the broad 
areas of HIV prevention, transmission, disease progression, consequences, and 
treatment, there is a great need for research on specific concerns arising 
from the convergence of adolescence, AOD use and abuse, and HIV/AIDS.  
Studies are needed to develop, test, and disseminate prevention strategies to 
reduce the incidence of alcohol-related HIV infection, including:

- community-based behavioral and social intervention strategies to reduce 
alcohol use and high-risk sexual behavior among adolescents and their sexual 
partners

- primary prevention programs that include both HIV and alcohol abuse 
prevention (especially the integration of HIV risk components with existing 
alcohol abuse prevention programs) in school, juvenile detention, and street 
settings

- family and other group-based intervention strategies to reduce alcohol use 
and high-risk sexual behavior among adolescents and their sexual partners

- screening procedures for use by healthcare providers to identify youth at 
risk for alcohol abuse and exposure to HIV, particularly those in elementary 
and middle schools.

- programs to improve access to and utilization of health services by 
alcohol-using HIV-infected adolescents, including strategies to improve 
adherence with HIV medications, recruit and retain participants in HIV/AIDS 
treatment, and deliver linked medical and drug abuse treatment services

- strategies to support the transition from pediatric to adolescent and from 
adolescent to adult health care settings that focus on reducing alcohol and 
sexual risk behaviors.

International Studies on Alcohol Abuse and HIV/AIDS: Although some developing 
countries have implemented successful HIV/STD prevention programs and 
policies, there is an urgent need to enhance these efforts and to find low-
resource, cost-effective prevention programs.  According to the World Bank, 
AIDS has eradicated a half-century of development in most affected countries.  
The impact on life expectancy among adults between the ages of 25 to 44 in 
staggering, and one child in ten is orphaned in Africa.  Recent data indicate 
that alcohol and other drug use, particularly when combined with high-risk 
unprotected sex, have contributed significantly to the spread of HIV in many 
parts of the world.

Epidemiologic studies on the dynamics of alcohol and other drug abuse and HIV 
demonstrate a continual need to reach new and emerging risk groups in diverse 
geographic settings with effective prevention interventions. This initiative 
encourages new and expanded collaborative efforts between U.S.-supported 
researchers and researchers in other nations to test behavioral interventions 
to arrest the spread of HIV infection and its consequences.  Suggested areas 
of focus include but are not limited to:

- development and testing of innovative, durable, and cost-effective 
interventions targeting individuals with co-occurring alcohol 
abuse/dependence and HIV/AIDS in diverse international settings to reduce 
their alcohol consumption and other high-risk behaviors.

- testing of comprehensive school-based education programs that include 
components of life skills and ways to prevent alcohol and other substance 
abuse and other high risk behaviors in pre-adolescent, adolescent, and young 
adult populations in developing countries.

- development and testing of combined AOD, HIV/STD and reproductive health 
programs to reduce HIV risk behaviors.

- identification of gender roles in acquisition and transmission of AOD-
related HIV and the development of preventive interventions that address 
these factors.

- developing interventions to change formal and informal communication 
patterns, including mass and local media, through which information regarding 
the relationship between AOD use and abuse and HIV/AIDS may be disseminated 
in high risk communities.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. 

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

DATA AND SAFETY MONITORING PLAN (applies if you have proposed a clinical 
trial):
As of the October 2000 receipt date, applicants must supply a general 
description of the Data and Safety Monitoring Plan for ALL clinical trials; 
this must be included in the application 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
The degree of monitoring should be commensurate with risk. NIH Policy for 
Data and Safety Monitoring requires establishment of formal Data and Safety 
Monitoring Boards for multi-site clinical trials involving interventions that 
entail potential risk to the participants. The absence of this information 
will negatively affect your priority score.

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 RFA 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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of the RFA in 
response to which the application may be submitted.  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 NIAAA staff 
to estimate the potential review workload and plan the review.

The letter of intent is to be sent to:

RFA-AA-02-003
Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 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 indicated.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in 
applying for these grants. This version of the PHS 398 is available in an 
interactive, searchable PDF format. For further assistance contact 
GrantsInfo, Telephone 301/435-0714, Email: GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only 
when there is a possibility for an award. It is anticipated that these 
changes will reduce the administrative burden for the applicants, reviewers 
and NIH staff.  The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.

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.

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 also 
be sent to:

RFA-AA-02-003
Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Bldg, Suite 409
6000 Executive Blvd, MSC 7003
Bethesda, MD  20892-7003
Rockville, MD  20852 (for express/courier service)

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.

Applications must be received by January 23, 2001.  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.  
 
REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIAAA. If the application is not responsive to the RFA, 
CSR staff may contact the applicant to determine whether to return the 
application to the applicant or submit it for review in competition with 
unsolicited applications at the next review cycle.

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 receive a written 
critique and 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, assigned a priority score, and receive a 
second level review by the National Advisory Council on Alcohol Abuse and 
Alcoholism.

Review Criteria

Criteria to be used in the scientific and technical merit review of the 
research grant applications will include the following:

Significance:  Does the study address the goals of the RFA?  If the aims of 
the application 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?

Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative designs?

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

Investigator:  Is the investigator appropriately trained and well suited to 
carry out this work?  Is the work appropriate to the experience level of the 
principal investigator and other researchers (if any)?

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

Budget:  Is the requested budget and estimation of time to completion of the
project appropriate for the proposed research?

In addition, plans for the recruitment and retention of subjects will be
evaluated as will the adequacy of plans to include both genders and 
minorities and their subgroups as appropriate for the scientific goal of the 
research.

The initial review group will also examine the provisions for the protection 
of human and animal subjects and the safety of the research environment.

Schedule

Letter of Intent Receipt Date:    December 28, 2001
Application Receipt Date:         January 23, 2002
Peer Review Date:                 March-April 2002
Council Review:                   May 2002
Earliest Anticipated Start Date:  July 1, 2002

AWARD CRITERIA

Applications recommended for approval by the National Advisory Council on 
Alcohol Abuse and Alcoholism will be considered for funding on the basis of 
the overall scientific and technical merit of the application as determined 
by peer review, NIAAA programmatic needs and balance, and the availability of 
funds.

INQUIRIES

Potential applicants are strongly encouraged to seek pre-application 
consultation, for which purpose they may contact the individuals listed 
below.

Direct inquiries regarding the proposed research to:

Deidra Roach, M.D.
Collaborative and Special Health Programs Branch - CSHPB
Office of Collaborative Research 
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard  MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-5820
FAX:  (301) 480-2358
Email:  droach@mail.nih.gov

Kendall Bryant, Ph.D.
Chief, Collaborative and Special Health Programs Branch - CSHPB
Office of Collaborative Research 
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard  MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 402-9379
FAX:  (301)	480-2358
Email:  kbryant@niaaa.nih.gov

Direct inquiries regarding fiscal matters to:

Judy Simons
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-2434
FAX:  (301) 443-3891
Email:  jsimons@niaaa.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance, No.
93.273.  Awards are made under the authorization of the Public Health Service
Act, Sections 301 and 464H, and administered under the PHS policies and 
Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects;" 
Title 45 CFR Parts 74 and 92, "Administration of Grants;" and 45 CFR Part 46, 
"Protections of Human Subjects."  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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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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