This Program Announcement expires on October 1, 2004, unless reissued.

CUTTING-EDGE BASIC RESEARCH AWARDS (CEBRA)

Release Date:  February 6, 2001

PA NUMBER:  PAR-01-047

National Institute on Drug Abuse
 (http://www.nida.nih.gov)

Application Receipt Date:  April 17, 2001, with standard receipt dates afterwards

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 Drug Abuse (NIDA) invites applications for Cutting-
Edge Basic Research Awards (CEBRA) to foster highly innovative or conceptually 
creative research that advances our understanding of drug abuse and addiction 
and how to prevent and treat them.  The CEBRA is a new mechanism designed by 
NIDA to foster novel research approaches and represents the high priority 
placed by NIDA on identifying such research.  NIDA currently supports a great 
deal of innovative biomedical research.  The CEBRA, however, is specifically 
designed to support research that is high-risk and potentially high-impact and 
that is underrepresented or not included in NIDA"s current portfolio.  It is 
aimed at experienced drug abuse research investigators who wish to develop or 
adapt new methods or techniques and at new investigators or scientists with 
expertise in fields other than drug abuse who wish to establish new programs 
in drug abuse research.  NIDA"s CEBRA program will provide rapid review and 
funding decisions of applications.  Successful applicants will be recognized 
by NIDA in an annual ceremony.

This solicitation will utilize the R21 mechanism with the opportunity for a 
competing continuation to provide support for highly innovative projects.  The 
R21 mechanism allows support for projects in the early, first stages of 
development (Stage I) where there is little or no preliminary data available, 
but which have a strong rationale and conceptual framework.  Successful 
applicants will be eligible to apply for a Stage II award (R01) that will 
continue the support of the innovative research initiated in Stage I (R21).  
Specific features of the CEBRA include:

o Transition from feasibility stage to development stage.
o Flexible budgeting of the Stage I grant.
o Expedited review convened by NIDA with a special emphasis on innovation for 
both stages.

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 PA, NIDA"s "Cutting-Edge Basic 
Research Awards (CEBRA)," 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

Given that the CEBRA is a new program, it is important that applicants consult 
with the appropriate NIDA staff listed under INQUIRIES for additional 
information as they are developing their applications.  Both Stage I and Stage 
II applications will be reviewed by review panels convened by NIDA.

Stage I Applications

For Stage I applications, this PA will use the National Institutes of Health 
(NIH) R21 award (http://grants.nih.gov/grants/guide/pa-files/PA-01-012.html) 
mechanism.  A Stage I award is limited to a 2-year effort and a maximum of 
$100,000 in direct costs per year.  However, in order to provide flexibility, 
well-justified costs exceeding $100,000 for one year of a grant will be 
considered.  Applicants should consult with NIDA staff.  The Stage I award is 
not renewable.

Stage II Applications

Only applicants who receive a Stage I award will be eligible to submit a Stage 
II application, which will be a new (Type 1) award using the R01 mechanism.  
The upper limit for a Stage II award will be $500,000 per year in annual 
direct costs for a period not to exceed three years.  Stage II applications 
will extend and expand the research initiated under Phase I.

Responsibility for the planning, direction, and execution of the proposed 
projects will be solely that of the applicant.  

FUNDS AVAILABLE

NIDA estimates that approximately $1 million in total funds [direct plus 
Facilities and Administrative (F&A) costs)] will be available under this PA in 
FY 2001 to fund four to seven new Stage I awards.  The Stage I (R21) award is 
limited to a 2-year effort and a maximum of $100,000 in direct costs per year.  
Additional Stage I and new Stage II awards will be made during FY 2002 and FY 
2003, subject to availability of funds.  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 PA are contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious applications.

RESEARCH OBJECTIVES

Background

Over the past years, basic science discoveries have consistently been the 
basis for many major advances in both clinical and applied drug abuse research 
and have contributed to the implementation of successful drug addiction 
treatment strategies.  Pharmacological, neurobiological, cell biological, and 
genetic research have provided insight into questions such as how each drug of 
abuse exerts its actions on the brain and other organs and produces addiction.  
Molecular, systems neurobiology, behavioral, and cognitive studies have shed 
light on how drugs of abuse affect both animal and human behavior.  For 
example, research has elucidated aspects of the processes of acquisition and 
relapse, led to the development of new molecular markers, and provided a more 
fundamental understanding of the functioning of receptors and transporters.  
However, there is a profound need to increase our understanding of drug abuse 
in order to develop effective treatment and prevention interventions to 
alleviate the pain and devastation of addiction.

The goal of NIDA"s CEBRA program is to accelerate the pace of discoveries that 
can advance addiction research by encouraging scientifically sound proposals 
that focus on innovation.  The CEBRA seeks to encourage researchers to explore 
new approaches, test imaginative new ideas, and challenge existing paradigms 
in drug addiction research in both human and animal models.  While NIDA 
currently supports many innovative and creative projects, the CEBRA is aimed 
at high-risk, high-impact research that is underrepresented or not included in 
NIDA"s current portfolio.  The proposed research should propose to either: (1) 
test highly novel and significant hypotheses for which there is scant 
precedent or preliminary data and which, if confirmed, would have a 
substantial impact on current thinking, or (2) develop or adapt innovative 
techniques or methods for addiction research.

There is enormous potential for advances when knowledge is generated and 
combined in new and unexpected ways.  Therefore, this announcement encourages 
applications from experienced drug abuse research investigators who wish to 
adapt new methods or techniques to study basic questions in drug abuse and 
addiction.  Also encouraged to apply are new investigators or investigators 
with expertise in fields other than drug abuse to establish new programs in 
drug abuse and addiction research.  

Exploratory/developmental studies are not intended for large-scale 
undertakings or to support or supplement ongoing research.  Instead, 
investigators are encouraged to explore the feasibility of an innovative 
research question or approach that will provide the basis for important future 
research, which may not be justifiable or have high likelihood of being 
supported through extant research mechanisms when competing as a standard 
research project grant (e.g., R01).

Recipients of the CEBRA R21 award will be eligible to apply for a second phase 
R01 award that will provide continued support for the successful innovative 
exploratory and developmental research initiated in Stage I, in order to allow 
the scientific concept to mature into a project that can be supported by 
standard grant mechanisms.  This program will utilize an expedited application 
process, with rapid review and feedback to the applicant.

Areas of interest

Examples of relevant research include but are not limited to the following:

o Applying novel or emerging technologies--such as biosensors, nanotechnology, 
or proteomics--to address questions about the neurobiology of drug abuse or 
addiction or synaptic remodeling.

o Using molecular biology, microscopy chemistry, and biochemistry approaches 
to develop new methods for regulating gene and protein function in vivo, 
detecting protein-protein interactions, localizing proteins in the nervous 
system, or directly measuring synaptic activity.

o Elucidating the role of cellular processes--such as mRNA translation 
regulation, trafficking systems, cytoskeletal organization, protein 
degradation, etc.--that have not been investigated extensively in previous 
studies of the cellular response to drugs of abuse.

o Discovering novel drug abuse-related signal transduction pathways or 
previously uncharacterized "crosstalk" interactions between known pathways.

o Applying molecular, neurochemical, and genetic approaches to explain the 
behavioral and biological bases of gender-specific differences in response to 
drugs of abuse.

o Applying high resolution imaging methods to study neuronal activity in awake 
and moving small animals.

o Applying multiple-channel, multi-site electrophysiological recording to 
understand the acquisition, maintenance, and long-term neural encoding of 
drug-seeking and drug-taking behaviors, including comparisons with the 
acquisition and performance of "natural" behaviors.  Also of interest is 
developing new computational methods for analyzing electrophysiological data 
from these studies.

o Using novel methods for high throughput screening for new drug templates or 
receptor-specific ligands, and developing new and faster methods to design 
super-agonists and antagonists for various receptor types and subtypes.

o Discerning functional interactions between non-opiate peptides and chemical 
neurotransmitters using methods other than anatomical or colocalization 
studies.

o Developing multi-dimensional behavioral assays capable of detecting drug-
seeking or drug-taking behaviors that are guided by a range of underlying 
psychological processes or states.  For example, studies on drug approach or 
consumption motivated by subjective experiences other than reward or hedonia.

o Using laboratory-based studies to explore vulnerability to drug dependence 
on the basis of sensitivity to aversive consequences and/or initial subjective 
response to drug effects.

o Developing new methods for training self-control based on contemporary 
cognitive science and cognitive neuroscience.

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 is 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 is 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.

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.

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 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: 
GrantsInfo@nih.gov.

The specific guidelines listed below on page limitations are for Stage I 
applications only and supersede the PHS 398 instructions.

The research plan for Stage I applications should not exceed 10 pages.  
Information regarding specific aims, background and significance, preliminary 
studies, and research design and methods are all included in this 10-page 
limit.  If human subjects are included in the proposed research, applicants 
must address the recruitment and inclusion of women and minorities, as it 
impacts the study design, within the 10-page research plan.  Tables, figures, 
and photographs are also included in the 10-page limit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

BUDGET INSTRUCTIONS

Modular grant applications will request direct costs in $25,000 modules.  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 
and Total Costs [Modular Total Direct plus 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 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 all 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 all personnel, 
and their 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:  
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.

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.

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 title and number of the program announcement must be typed on line 2 of 
the face page of the application form, and the YES box must be marked.

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)

To permit an expedited review of the applications, applicants must 
simultaneously send two additional copies of the application to:

Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for express/courier service)

After the single receipt date of April 17, 2001, the standard receipt dates 
(June 1, October 1, and February 1) will apply to this PA.  However, no 
applications will be considered for the June 1, 2001, receipt date.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the NIH Center 
for Scientific Review (CSR).  Both Stage I and II applications that are 
complete will be evaluated for scientific and technical merit by an 
appropriate peer review group convened by NIDA in accordance with NIH peer 
review procedures.  As part of the initial merit review, all applications will 
receive a written critique, and may undergo a process in which only those 
applications deemed to have the highest scientific merit will be discussed, 
assigned a priority score, and receive a second level review by the National 
Advisory Council on Drug Abuse.

In approximately seven months, NIDA staff will notify applicants whether or 
not the application will be funded.  No funding will occur during the months 
of October and November.

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?  A strong rationale and conceptual framework may be 
considered sufficient for establishing the feasibility of the project, in lieu 
of extensive preliminary data.

(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 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, and children 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 recommended 
applications.  The following will be considered in making funding decisions:  
quality of the proposed project as determined by peer review, availability of 
funds, and program priority.

INQUIRIES

Potential applicants are strongly encouraged to contact the appropriate staff 
for additional information and specific application procedures or to clarify 
any issues.

Direct inquiries regarding programmatic issues to:

Dr. Rebekah S. Rasooly
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4260, MSC 9555
Bethesda, MD  20892-9555
Telephone:  (301) 443-6300
FAX:  (301) 594-6043
Email:  rr185i@nih.gov

Direct inquiries regarding review matters to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  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 Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
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 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 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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