NIAAA EXPLORATORY/DEVELOPMENTAL GRANT (R21) PROGRAM

Release Date:  August 2, 1999

PA NUMBER:  PA-99-131

National Institute on Alcohol Abuse and Alcoholism

Application Receipt Dates:  October 1, February 1, and June 1

THIS PROGRAM ANNOUNCEMENT (PA) USES THE "MODULAR GRANT" AND "JUST-IN-TIME"
CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION
INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS
PA.

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites
applications for Exploratory/Developmental Grants (R21) that fall within its
research interests.

The objective of the exploratory/developmental mechanism (R21) is to encourage
applications from individuals who are interested in testing innovative or
conceptually creative ideas that are scientifically sound and may advance our
understanding of alcohol abuse and alcoholism.  Another objective is to
encourage necessary initial development to provide a basis for important
future research.

These are short-term awards (up to three years) with limited funding (up to
$100,000 per year for direct costs).  Investigators are encouraged to use this
mechanism to explore the feasibility of an innovative research question or
approach, which may not be justifiable through extant research, or competitive
as a standard research project grant (R01).

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 or foreign 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.

MECHANISM OF SUPPORT

Applicants may request up to $100,000 in direct costs per year for up to three
years through the NIAAA Exploratory/Developmental Grant (R21) 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.  Investigators are
encouraged to seek continued support for their research projects through a
research project grant (R01).

Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.
Complete and detailed instructions and information on Modular Grant
applications can be found at
https://grants.nih.gov/grants/funding/modular/modular.htm .

RESEARCH OBJECTIVES

The NIAAA Exploratory/Developmental Grant (R21) Program provides limited
financial support for exploring the feasibility of innovative or creative
research questions within the research 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 alcoholism, alcohol abuse and alcohol-related
problems.

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

Examples of studies suitable for the exploratory/developmental 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 epidemiologic or
prevention studies;

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

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

Applicants desiring to apply for Developmental Grants for Minority
Collaborative Projects PAR-96-036 or Development Grants for Collaborative
International Projects PA-96-033, should refer to these program announcements
on the NIAAA Home Page at http://www.niaaa.nih.gov .

Applicants should also be aware of the program announcements for the NIAAA
Small Grant (R03) Program PA-99-098 and the NIAAA Behavioral Science Track
Awards for Rapid Transition (B-START) PA-99-043.  These two programs are for
small grants (R03) for pilot studies for up to $50,000 per year for direct
costs for up to two years. The two NIAAA R03 programs limit the Research Plan
(Sections A-D) to a total of 10 pages and also provide for expedited review
and funding in a six or seven month period.  This is two to three months
shorter than the normal funding cycle for regular research grants (R01).  The
Small Grant (R03) and B-START program announcements are also available on the
NIAAA Home Page.

Applicants are requested to contact appropriate program staff at NIAAA for
assistance in preparation of an application. Appropriate staff contacts are
listed under INQUIRIES.

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 (FR59 14508-14513) and in the NIH Guide for Grants
and Contracts, Volume 23, Number 11, March 18, 1994. These may be accessed at:
https://grants.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html.

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:
https://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.

APPLICATION PROCEDURES

Applicants are strongly encouraged to contact the program staff listed under
INQUIRIES with any questions regarding their proposed project and the goals of
this PA.

The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. The standard application deadlines as indicated in
the application kit should be followed. Application kits are available at most
institutional offices of sponsored research and from the Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301)
710-0267, Email: [email protected]. Applications are also available on the
World Wide Web at: https://grants.nih.gov/grants/forms.htm .

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, reviewer's and Institute
staff. The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up to
a total direct cost request of $100,000 per year. The total direct costs must
be requested in accordance with the program guidelines and the modifications
made to the standard PHS 398 application instructions described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $100,000) and Total Costs [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period Items 8a and 8b should be completed indicating the Direct and Total
Costs for the entire proposed period of support.

o 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.

o 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.

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for sample
pages.) At the top of the page, enter the total direct costs requested for
each year. This is not a Form page.

o Under Personnel, list key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided. However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each 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. Include the Letter of
Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o 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:
https://grants.nih.gov/grants/funding/modular/modular.htm .

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects  ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations;

o 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. All appropriate exclusions must be applied in the
calculation of the F&A  costs for the initial budget period and all future
budget years.

o The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.

Applications not conforming to these guidelines will be considered
unresponsive to this PA and will be returned without further review. The title
and number of the program announcement must be typed in Section 2 on the face
page of the application.

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 MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

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 and receive a secondary review by the National Advisory Council
on Alcohol Abuse and Alcoholism.

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 consideration pertinent to the review of Exploratory/Developmental
Grant (R21)applications:

- Pilot/feasibility studies may 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 recommended
applications.  The following will be considered in making funding decisions:

-  quality of the proposed project as determined by peer review;
-  program balance and priorities; and
-  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:

Capt. Darryl Bertolucci
Division of Biometry and Epidemiology
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 443-4898
Fax: (301) 443-8614
Email: [email protected]

Dr. Joanne Fertig
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 443-0635
Fax: (301) 443-8774
Email: [email protected]

Dr. Thomas Kresina
Division of Basic Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 443-4224
Fax: (301) 594-0673
Email: [email protected]

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: [email protected]

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 Parts 74 and 92.  This program is not subject
to the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

The PHS strongly encourages all grant 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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