EXPLORATORY/DEVELOPMENTAL GRANT APPLICATIONS

NIH GUIDE, Volume 26, Number 36, October 24, 1997

P.T.

PA NUMBER:  PA-98-004

National Institute on Drug Abuse

PURPOSE

This program announcement is to notify the extramural research community that
National Institute on Drug Abuse (NIDA) accepts exploratory/developmental grant
applications that fall within its program 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 drug abuse and addiction.  Another objective is to encourage
necessary initial development to provide a basis for important future research
in a particular field.

Investigators experienced in drug abuse research who wish to adapt new methods
or techniques established in other fields to study scientific avenues in drug
abuse research are encouraged to apply.  Also encouraged to apply are
investigators with expertise in fields other than drug abuse to establish new
programs in drug abuse research. Exploratory/ developmental studies are not
intended for large scale undertakings, nor to support or supplement ongoing
research. Instead, investigators are encouraged to explore the feasibility of an
innovative research question or approach which may not be justifiable through
extant research to compete as a standard research project grant (e.g., R01), and
to develop a research basis for a subsequent application through other
mechanisms; i.e., R01, R29, P01.

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.  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 REQUIREMENTS

Applications may be submitted by foreign and 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.

MECHANISM OF SUPPORT

The National Institutes of Health (NIH) exploratory/developmental grants
mechanism (R21) will be used.  In general, the requested funding for the
exploratory/developmental projects should be modest.  A grant supported under
this program announcement is limited to a three-year effort and a maximum of
$90,000 in direct costs per year.  However, well justified costs exceeding
$90,000 may be considered only in exceptional cases of justifiably expensive
methodology  (e.g., PET imaging technology).  These awards are not renewable.

Grant funds may be used for expenses clearly related and necessary to conduct
research projects, including both direct costs that can be specifically
identified with the project and allowable indirect costs of the institution. 
Funds may not be used to establish, add a component to, or operate a treatment,
rehabilitation, or prevention/intervention service program.  Support for
research-related treatment, rehabilitation, or prevention services and programs
may be requested only for costs required by the research.  These costs must be
justified in terms of research objectives, methods, and designs that promise to
yield generalizable knowledge and/or significant contributions to theoretical
concepts.

The relevance of the proposed work to the mission of NIDA should be clearly
described, and a brief rationale for the use of the R21 mechanism should be
provided in the specific aims section.  The application should be focussed and
should present sound arguments leading to a testable hypothesis.  The
significance, importance, or potential impact of the proposed research should be
clearly discussed and the procedures, data analyses, and the expected conclusions
should be well described.  Experienced investigators whose research has been
outside the drug abuse field are encouraged to use the R21 mechanism to explore
new avenues and approaches to the understanding of drug taking behavior or to
develop novel treatment entities for drug addiction.

RESEARCH OBJECTIVES

Any research objective within NIDA's programmatic interest is acceptable under
this announcement.  Applicants are requested to contact appropriate program staff
at NIDA for assistance in preparation of applications.  For help in locating
program staff, refer to NIDA's Home Page (http://www.nida.nih.gov) or contact
staff 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.  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
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research," which were published in the Federal Register on March 28, 1994 (FR 59
14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS

The National Advisory Council on Drug Abuse recognizes the importance of research
involving the administration of drugs to human subjects and has developed
guidelines relevant to such research.  Potential applicants are encouraged to
obtain and review these recommendations before submitting an application that
will administer compounds to human subjects.  The guidelines are available on
NIDA's Home Page at http://www.nida.nih.gov or may be obtained by calling (301)
443-2755.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) and will be accepted at the standard application deadlines as indicated in
the application kit.  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) 710-0267, email:
asknih@od.nih.gov.  The application kit is also available on the web at
http://www.nih.gov/grants/funding/phs398/phs398.html.  The title and number of this
program announcement must be typed on line 2 on the face page of the application.

The completed original application and five legible copies must be sent or
delivered to:

CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants)
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20897 (for overnight/courier service)

REVIEW CONSIDERATIONS

Applications will be evaluated for scientific and technical merit by an
appropriate peer review group convened in accordance with the standard 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, assigned a priority score, and will
receive a second level review by the appropriate national advisory council or
board.

Review Criteria

The goals of NIH-supported research are to advance the 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 the
application 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 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 major scientific impact and
thus deserve a high priority score.

(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?  In the context of the R21 mechanism, a strong rationale and
conceptual framework are normally sufficient for establishing the feasibility of
the project, in lieu of extensive preliminary data.

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

(4)  Investigator:  Is the investigator appropriately trained and well suited to
carry out this 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?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities, and their
subgroups, as appropriate for the scientific goals of the research.  Plans for
the recruitment and retention of subjects will
also be evaluated.

o  The reasonableness of the proposed budget and duration in relation to the
proposed research.

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

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to NIDA.  The following will be considered in making
funding decisions:  quality of the proposed project as determined by peer review,
availability of funds, and program priorities.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Harold Gordon, Ph.D.
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A46
Rockville, MD  20857
Telephone:  (301) 443-4877
FAX:  (301) 443-6814
Email:  hg23r@nih.gov

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 10-42
Rockville, MD  20857
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  gf6s@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.279. 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
and 285), and administered under PHS grants policies and Federal Regulations 42
CFR 52 and 45 CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems.

The Public Health Service (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 of 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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