DEVELOPMENT OF BEHAVIORAL METHODS FOR DRUG ABUSE STUDIES IN THE MOUSE

Release Date:  May 3, 2000

RFA:  DA-01-002

National Institute on Drug Abuse

Letter of Intent Receipt Date:  July 21, 2000 
Application Receipt Date:       August 22, 2000

THIS REQUEST FOR APPLICATIONS (RFA) 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 
RFA.

PURPOSE

The National Institute on Drug Abuse (NIDA) announces the availability of 
funds to develop or adapt behavioral models and methods for the mouse to 
advance the understanding of drug abuse and addiction.  The rat has been the 
most commonly used organism for preclinical behavioral and neurobiological 
research, and a wealth of data relevant to drug abuse and addiction have been 
collected in this species.  However, the best-developed vertebrate genetic 
model organism is the mouse, for which there is a rich collection of well-
characterized mutations and genes.  Through investment of significant funds 
from the NIH, many genetic tools are being developed that will enhance mouse 
research, such as the complete mouse genome sequence, large collections of new 
mutations, phenotypic characterization of common laboratory strains, and 
techniques for regionally and temporally specific gene targeting (see 
http://www.nih.gov/science/models/mouse/).  It is anticipated that the mouse 
will become increasingly valuable as a model system for behavioral, 
neurobiological, and pharmacological research that relates to drug-abuse 
vulnerability and processes of addiction.  NIDA has initiated this Request for 
Applications in order to increase the number of laboratories capable of using 
behavioral approaches to study and develop models of drug abuse and addiction 
in the mouse.  

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 Request for Applications (RFA), 
Development of Behavioral Methods for Drug Abuse Studies in the Mouse, 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.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and 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

This RFA will use the National Institutes of Health (NIH) 
exploratory/developmental grant (R21).  Responsibility for the planning, 
direction, and execution of the proposed project will be solely that of the 
applicant.  The total project period for an application submitted in response 
to this RFA may not exceed three years.  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 April 2001.  For 
further information on the R21 mechanism, see 
http://grants.nih.gov/grants/guide/pa-files/PA-98-004.html (note that the 
budget limitation has been increased to conform with the guidelines for 
modular budgets).

FUNDS AVAILABLE

NIDA intends to commit approximately $1,000,000 in FY 2001 to fund 10-15 new 
grants in response to this RFA.  An applicant may request a project period of up 
to three years and a budget for direct costs of up to $100,000 per year.  Because 
the nature and scope of the research proposed may vary, it is anticipated that 
the size of each award will also vary.  Although the financial plans of NIDA 
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.  

RESEARCH OBJECTIVES

Background

Drug addiction is a chronic relapsing disease that has many characteristics, 
including a persistent desire or compulsion to use a drug, loss of control of 
drug intake, reduction in other important activities because of drug use, 
continued use despite knowledge of harm, marked tolerance, characteristic 
withdrawal symptoms, and an increased negative emotional state or stress when 
the drug is unavailable.  The process of becoming addicted to drugs often 
begins with non-compulsive or less frequent use, which over time can lead to 
compulsive, uncontrollable drug taking.  Relapse to drug use occurs following 
short or long periods of abstinence and may result from stress and/or 
reexposure to environments previously associated with drug use.  Individuals 
addicted to drugs have been known to report intense "craving" for an abused 
drug.  NIDA supports more than $600 million in drug abuse research annually 
and serves as the foundation of the Nation's investment in understanding the 
causes, consequences, and treatment of drug addiction.  As part of this 
research endeavor, NIDA has supported research in animal models of addiction 
that use behavioral, neurobiological, pharmacological, and genetic approaches.

Behaviorally based animal research has proven highly useful in explaining the 
underlying behavioral and neurobiological processes involved in drug abuse.  
Research that exploits genetically defined mice is being used (1) to 
investigate factors that determine individual differences in drug abuse 
vulnerability; (2) for molecular investigations, such as the role of different 
receptor subtypes in drug effects; and (3) to alter the function of specific 
brain areas or cellular processes to determine their role in drug-related 
behaviors.  To characterize differences among mouse strains or to determine 
how a specific null mutation may affect behavior, it is becoming more 
important to conduct converging behavioral tests.  Grants funded under this 
RFA might be used to complement ongoing research projects currently aimed at:  
1) characterizing behavior of other animal species (e.g., rat), including 
behavioral aspects of drug abuse and addiction, where new funds would be used 
to adapt this research to the mouse; or 2)investigating in the mouse the 
behavioral consequences of strain differences or mutations arising from large 
scale mutagenesis or gene targeting, where new funds would be used to extend 
these studies to behaviors related to drug abuse, such as the development of 
new screening methods or the investigation of the influence of particular 
genes on behavioral phenotype.

Areas of Interest

Appropriate studies for this RFA might include, but are not limited to, the 
following areas:

1.  The development of methods for studying in the mouse a variety of 
behaviors involved in or related to drug taking, drug seeking, or motivational 
processes.  The proposed research could include the study of: impulsive 
behavior; acquisition or maintenance of drug-directed behavior; behavioral 
models of drug relapse, including stress- or cue-induced relapse; narrowing of 
behavioral repertoire; compulsive behavior; reproductive or affiliative 
behavior; or behavioral measures of drug sensitization, tolerance, or 
withdrawal.  Methods used in other animal species, such as the rat, could be 
adapted to the mouse, or the proposed research could exploit species-typical 
behaviors of the mouse.

2.  Phenotypic characterization of behaviors that are related to drug taking 
and drug seeking or indicative of related central motivational states in 
different laboratory mouse strains or in genetically altered mice.

3.  The development of methods for rapid and/or automated phenotypic 
screening, such as automated methods for measuring drug directed or related 
behaviors, or for measuring behavioral responsivity to drugs of abuse or 
potential therapeutic agents.

4.  The development of novel methods of drug self administration, which are 
less technically difficult and more easily implemented than traditional 
methods, for rapid screening of behavioral phenotype.

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, by July 21, 
2000, 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 
NIDA staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent to:

Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Blvd., Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for courier/express service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms 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, E-mail:  GrantsInfo@nih.gov.  Forms are also available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.  

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

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 for 3 years under the R21 
mechanism.  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

FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs 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.

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 - Prepare a Modular Grant Budget Narrative 
page. (See http://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.

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 F&A) 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.

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://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; and
- List selected peer-reviewed publications, with full citations.

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.

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. 

The RFA label available in the PHS 398 (rev. 4/98) 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 sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

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:

Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Blvd., Room 3158, MSC 9547
Bethesda, MD  20892-9547
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.

The Center for Scientific Research (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 NIDA.  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 NIDA in accordance with the review criteria stated below.  As part of the 
initial merit review, a process will be used by the initial review group in 
which applications 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 NIDA National 
Advisory Council or Board.

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 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.  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?  For the R21 mechanism, a strong rationale and conceptual 
framework may be 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, the application will also be reviewed with 
respect to the reasonableness of the proposed budget and duration in relation 
to the proposed research.

Schedule

Letter of Intent Receipt Date:    July 21, 2000
Application Receipt Date:         August 22, 2000
Peer Review Date:                 November/December 2000
Council Review:                   January 2001
Earliest Anticipated Start Date:  April 2001

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

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Susan Volman, Ph.D.
Division of Neurosciences & Behavioral Research
Behavioral Neurobiology Research Branch
National Institute on Drug Abuse
6001 Executive Blvd., Room 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:	(301) 435-1315
FAX:		(301) 594-6043
Email:  	sv36h@nih.gov

Minda Lynch, Ph.D.
Division of Neurosciences & Behavioral Research
Behavioral Sciences Research Branch
National Institute on Drug Abuse
6001 Executive Blvd., Room 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:  (301) 435-1322
FAX:		(301) 594-6043
Email:  	mlynch@nida.nih.gov

Direct inquiries regarding review matters to:

Teresa Levitin, Ph.D.
Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Blvd., Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:	(301) 443-2755
FAX:  	(301) 443-0538
E-mail:  	tl25u@nih.gov

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Blvd., MSC 9541
Bethesda, MD  20892-9541
Telephone:	(301) 443-6710
FAX:  	(301) 443-6847
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 Sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered 
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 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 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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