NIAAA SMALL GRANT PROGRAM

Release Date:  May 7, 1999

PA NUMBER:  PAR-99-098

P.T.

National Institute on Alcohol Abuse and Alcoholism

THIS PROGRAM ANNOUNCEMENT (PA) USES MODULAR GRANT PROCEDURES. IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. (SEE APPLICATION PROCEDURES.
ALSO SEE MODULAR GRANT APPLICATION AND AWARD NOTICE
http://www.nih.gov/grants/guide/notice-files/not98-178.html

This PA replaces and supersedes the NIAAA portion of PA-91-08.

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites Small
Grant (R03) applications relating to research on alcohol-related problems.  These
are short-term awards (up to two years) with limited funding (up to $50,000 per
year for direct costs) that are intended to provide support for pilot/feasibility
projects, testing of new techniques, secondary analysis of existing data, or
development of innovative or high-risk projects that could provide a basis for
submission of a regular research project grant application.  An NIAAA Small Grant
may also be used as a pilot or planning grant for the design and coordination of
full-scale clinical trials. The program is also intended to stimulate and
facilitate the entry of less experienced investigators  and established
investigators in other fields into alcohol-related research and shorten the time
for the application award process.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This program announcement is related to
several priority areas applicable to alcohol abuse and alcoholism.  Potential
applicants may obtain a copy of "Healthy People 2000" at
http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of the
Federal Government.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.  Foreign
organizations and institutions are not eligible.  Participation in the program
by investigators at minority institutions is strongly encouraged.

Small grant support may not be used to supplement research projects already being
supported or to provide interim support of projects under review by the National
Institutes of Health (NIH).  Simultaneous submission of both a small and regular
research project grant (R01) on the same topic is not permitted.  Small grant
support may not be requested for thesis or dissertation research.

MECHANISM OF SUPPORT

Applicants may request either $25,000 or $50,000 in direct costs per year for up
to two years through the Small Grant (R03) mechanism. Facilities and
Administrative (F&A) costs will be awarded based on the negotiated rate at the
time of the award. These awards are not renewable; however, a no-cost extension
of up to one year may be granted to the grantee institution prior to expiration
of the project period. Before completion of the R03, investigators are encouraged
to seek continuing support for research through a research project grant (R01).

Replacement of the Principal Investigator on this award is not permitted.

RESEARCH OBJECTIVES

The NIAAA Small Grant Program provides limited financial support for research
within the program interests of the NIAAA.  This includes basic and applied
research on biochemical, physiological, genetic, and behavioral mechanisms
leading to pathological drinking behavior; mechanisms of alcohol-induced organ
damage, including fetal injury; and clinical, behavioral, and epidemiological
approaches to more effective diagnosis, prevention, and treatment of alcohol
abuse and alcoholism and the associated problems.

While applications may involve a wide variety of biomedical, behavioral, or
clinical disciplines, relevance to the mission of the NIAAA must be clear.  The
Institute's mission statement, research program description, and special emphasis
areas may be found at the NIAAA's Internet website: http://www.niaaa.nih.gov.

Examples of studies suitable for the small grant mechanism include, but are not
limited to:

- Studies on the etiology of alcoholism;

- Validation of alcohol-related behavioral phenotypes suitable for genetic
analysis;

- Development of new models to study alcohol preferences, reinforcement,
tolerance and craving at different life stages;

- Development of improved methods, either biological or behavioral, for
identifying individuals at risk for alcohol abuse/alcoholism or its medical
consequences;

- Development of prototypic therapeutic agents to reduce alcohol consumption,
reverse craving, reduce acute intoxication, and prevent withdrawal-related brain
damage;

- Development of prototypic therapeutic agents to prevent or treat the medical
consequences of alcohol abuse, including effects on the developing fetus;

- Pilot clinical trials to evaluate the potential efficacy of new pharmacological
or behavioral approaches to treatment or prevention of alcohol-related problems;

- Studies to test putative markers of alcohol consumption or markers of fetal
alcohol exposure;

- Evaluation of new approaches to study mechanisms of organ and tissue injury,
such as liver, pancreas, heart, brain, and fetus;

- Development, modification, or enhancement of instruments, techniques, or
analytic strategies to assist in alcoholism treatment or prevention studies;

- Planning grants or pilot testing for planned large, complex clinical trials,
prevention programs, genetic studies, or epidemiological studies; and

- Secondary analyses of large data sets to test new hypotheses.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification are provided that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research.  All
investigators proposing research involving human subjects should read the NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research, which have been published in the Federal Register of March 28, 1994 (FR
59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number
11, March 18, 1994. These may be accessed at:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.

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

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://www.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.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and prepared according to the directions in the application packet, with
the exceptions noted below.  Application kits are available at most institutional
offices of sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301)435-0714, FAX (301) 480-
0525, Email: grantsinfo@nih.gov.

On the face page of the application, Item 2, type "NIAAA SMALL GRANT PROGRAM -
PAR-99-098." Check the "YES" box.

RESEARCH PLAN: Do not exceed a total of 10 pages for the following parts (a-d):
Specific Aims, Background and Significance, Progress Report/Preliminary Studies,
and Experimental Design and Methods.  Tables and figures are included in the 10-
page limitation.  Applications that exceed the page limitation or PHS
requirements for type size and margins(refer to PHS 398 application instructions
for details) will be returned to the investigator.  The 10-page limitation does
not include parts e through i. (Human Subjects, Vertebrate Animals, Literature
Cited, Consortium Arrangements, Consultants).

The NIAAA Small Grant Program will follow modular procedures for application
instructions and award. The following changes to the instructions in the PHS 398
form pertain to the use of the modular application and award process. Use these
instructions to complete the application.

FACE PAGE:  Item 7a should be completed, indicating Total Direct Costs for the
first year requested either as $25,000 or $50,000 annual direct costs.  Item 7b
should reflect Total Costs (Modular Total Direct plus Facilities and
Administrative (F&A) costs) for the first year.  Items 8a and 8b should be
completed indicating the Direct and Total Costs for the entire proposed period
of support.

DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of
the PHS 398.  It is not required and will not be accepted with the application.

BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398.  It is not required and
will not be accepted with the application.

NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page. (See
sample at http://www.nih.gov/grants/funding/modular/modular.htm.)  At the top of
the page enter the total direct costs requested.

Under Personnel, list key project personnel; including their names, percent of
effort, and roles on the project. No individual salary information should be
provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct and
F&A) for each year rounded to the nearest $1,000.  List the
individuals/organizations with whom consortium or contractual arrangements have
been made, the percent effort of key personnel, and the role on the project. 
Indicate whether the collaborating institution is foreign or domestic. The total
cost for a consortium/contractual arrangement is included in the overall
requested modular direct cost amount.

BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall qualifications
of the research team.  A biographical sketch is required for all key personnel,
following the instructions below. No more than three pages may be used for each
person.  A sample biographical sketch may be viewed at:
http://www.nih.gov/grants/funding/modular/modular.htm.

o  Complete the educational block at the top of the form page;

o  List current position(s) and then previous positions;

o  List selected peer-reviewed publications, with full citations; and

o  Provide information, including overall goals and responsibilities, on research
projects ongoing or completed during the last three years.

CHECKLIST - This page should be completed and submitted with the application. 
If the F&A rate agreement has been established, indicate the type of agreement
and the date. It is important to identify all exclusions that were used in the
calculation of the F&A costs for the initial budget period and future budget
year.

Submit a signed original of the application and five exact photocopies,
including the checklist, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 þ MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

The submission, review, and award schedule for the NIAAA Small Grant Program
is:

Application Receipt Dates:   Feb 1    Jun 1    Oct 1
Institute Committee Review:  Jun      Oct      Feb
Earliest Funding:            Aug      Dec      Apr

REVIEW CONSIDERATIONS

Applications that are complete will be evaluated for scientific and technical
merit by an appropriate peer review group convened in accordance with the
standard NIH peer review procedures. 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 applications under review, will be discussed and assigned a priority
score.

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 review, comments on the following aspects of the application will be made
in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. Each of these criteria will be
addressed and considered by the reviewers in assigning the overall score
weighting them as appropriate for each application. Note that the application
does not need to be strong in all categories to be judged likely to have a major
scientific impact and thus deserve a high priority score. For example, an
investigator may propose to carry out important work that by its nature is not
innovative, but is essential to move a field forward.

1. Significance.  Does this study address an important problem? 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?

2.  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 tactics?

3.  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?

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

5.  Environment.  Does the scientific environment in which the 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?

The initial review group will also examine the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders,
minorities and their subgroups, and children as appropriate for the scientific
goals of the research and plans for the recruitment and retention of subjects;
the provisions for the protection of human and animal subjects; and the safety
of the research environment.

Additional considerations pertinent to the review of Small Grant (R03)
applications:

- Because the research plan is limited to 10 pages, a Small Grant application may
not have the same level of detail or extensive discussion normally found in an
R01 application.  Review emphasis should be placed on conceptual framework and
general approach to the problem, with less emphasis on methodological details.

- Pilot/feasibility studies contain little or no preliminary data.  Review 
should focus on whether the rationale for the study is well developed and whether
the proposed research is likely to generate data that will lead to a regular
research project grant or full-scale clinical trial. Adequate justification for
the proposed work may be provided through literature citations, data from other
sources, or investigator-generated data.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding decisions:

o  quality of the proposed project as determined by peer review;
o  program balance and priorities; and
o  availability of funds.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions
from potential applicants is welcome.

Direct inquires regarding programmatic issues to:

Dr. Ernestine Vanderveen
Division of Basic Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 443-2530
Fax: (301) 594-0673
Email: tv9f@nih.gov

Dr. Richard Fuller
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 443-1206
Fax: (301) 443-8774
Email: rf396@nih.gov

Dr. Mary Dufour
Division of Biometry and Epidemiology
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 443-3851
Fax: (301) 443-8614
Email: md68i@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Judy Simons
Grants Management Branch
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: js182a@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.273.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410), as amended by Public Law 99-158, 42 USC
241, 285 and 290) and administered under NIH grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74 or Part 92, as appropriate.  This
program is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products.  In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, 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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