DEVELOPING TRANSLATIONAL RESEARCH IN BEHAVIORAL SCIENCE

Release Date:  November 8, 2000

RFA:  MH-01-005

National Institute of Mental Health
 (http://www.nimh.nih.gov/)
National Institute on Drug Abuse
 (http://www.nida.nih.gov/)

Letter of Intent Receipt Date:  February 11, 2001
Application Receipt Date:       April 11, 2001

THIS RFA USES "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 of Mental Health (NIMH) and the National Institute on 
Drub Abuse (NIDA) seek to encourage the development of collaborative 
partnerships between scientists who study basic behavioral processes (e.g., 
cognition, emotion, decision making, social networks, culture) and those who 
study the etiology, diagnosis, treatment, and prevention of mental and 
behavioral disorders (including drug abuse and addiction) and the delivery of 
services to those suffering from those disorders.  NIMH and NIDA are issuing 
this Request for Applications (RFA) as a catalyst for a major, long-term 
commitment to (a) encourage the systematic translation of basic behavioral 
theory, methods, and findings into research designed to reduce the burden of 
mental illness and behavioral disorders and (b) encourage basic behavioral 
scientists to seek a further understanding of behavioral processes through an 
exploration of how those processes are altered by mental and behavioral 
disorders.  This RFA was developed in response to a report written by the 
National Advisory Mental Health Council’s Behavioral Science Workgroup, entitled 
“Translating Behavioral Science into Action,” 
http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm.

This RFA contains three mechanisms to support varying types of translational 
research partnerships:  (1) networking grants for the initiation of research 
partnerships; (2) developmental grants for the initial instantiation of 
translational research projects; and (3) research project grants for single and 
multisite translational research projects.

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 RFA, Developing Translational 
Research in Behavioral Science, 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 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.  Foreign institutions are not eligible for projects to be 
funded for this program.  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), Research Project Grant (R01), and 
Collaborative R01 award mechanisms.  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 5 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 September 30, 2001.

For all competing R21 and R01 applications requesting up to $250,000 direct 
costs per year, 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  
http://grants.nih.gov/grants/funding/modular/modular.htm.  

FUNDS AVAILABLE

The NIMH intends to commit approximately $2,750,000 in FY 2001 to fund 6 to 10 
new grants in response to this RFA, and NIDA plans to commit approximately 
$300,000 in FY 2001.  For a networking grant (R21), an applicant may request a 
project period of up to 3 years and a budget for direct costs of up to $150,000 
per year; this award is nonrenewable.  For networking grants that include more 
than one institution, direct costs of up to $175,000 per year may be requested 
to allow for facilities and administrative (F&A) costs on consortium 
arrangements.  For a developmental grant (R21), an applicant may request a 
project period of up to 5 years and a budget for direct costs of up to $350,000 
per year, excluding F&A costs on consortium arrangements; this award is also 
nonrenewable, and is not transferable to another institution.  Finally, a 
translational research project (R01) may involve either a single Principal 
Investigator or a group of investigators using the Collaborative R01 mechanism; 
applicants may request a project period of up to 5 years, with a budget 
determined by the work proposed.  Applicants for the Collaborative R01 Grant are 
strongly encouraged to familiarize themselves with the NIMH announcement 
(http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html), and direct 
questions to program staff listed in this announcement.  While the F&A costs 
associated with all contractual and consortium arrangements are considered as 
direct costs to the applicant organization, for the purposes of this 
announcement only, these will not count against the direct cost limits noted 
above for developmental grant applications over the modular grant limit of 
$250,000.  (However, these costs should be indicated as instructed on Form 398, 
rev. 4/98.)

Because the nature and scope of the research proposed may vary, it is 
anticipated that the size of each award will also vary.  It is expected that 
direct costs for R01 applications will be awarded in modules of $25,000 up to 
the modular grant limit of $250,000; however, program and grants management 
adjustments may be necessary prior to the award.  Although the financial plans 
of the Institute 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 applications of outstanding scientific and technical merit.  At this 
time, it is not known if competing renewal applications will be accepted and/or 
if this RFA will be reissued.

RESEARCH OBJECTIVES

Background

NIMH and NIDA have for many decades been primary sponsors of research in the 
basic behavioral sciences.  This long-term investment in behavioral research has 
resulted in the development of a large body of knowledge in such areas as 
emotion, motivation, self-concept, personality, cognition, memory, social 
cognition and influence, family processes, social networks, and sociocultural 
variations (see http://www.nimh.nih.gov/publicat/basbehav.cfm).  However, the 
theory, methods, knowledge, and insights from the basic behavioral sciences have 
not been fully utilized in understanding pressing public health issues in mental 
health and drug abuse: the etiology and assessment of disorders; the development 
of innovative preventive and treatment interventions; and the effects of 
interventions and services for diverse types of people in disparate social, 
economic, cultural, and environmental contexts.  

In 1999, the NIMH Director and the National Advisory Mental Health Council 
convened the Behavioral Science Workgroup to explore ways to increase the impact 
of behavioral science research on public mental health issues.  The Workgroup 
was comprised of experts in social, cognitive, developmental, and clinical 
psychology, psychophysiology, anthropology, sociology, public health, and 
biostatistics.  In their report, "Translating Behavioral Science into Action," 
they highlighted three priority areas of translational behavioral science 
research:

o  Basic behavioral processes in mental illness
o  Functional abilities in mental illness
o  Contextual influences on mental illness and its care

Regarding these three areas, the Workgroup wrote:  "These priority research 
areas are critical starting points for progress in translational science because 
they are at the interface of what end-users have identified as important and 
what behavioral science researchers regard as areas of opportunity.  They offer 
the prospect of conducting exciting research, advancing scientific understanding 
of behavior-in health and in illness-and improving the mental health of our 
Nation."
 
The workgroup recommended that NIMH "establish and publicize translational 
behavioral science research as a priority funding area...and develop a coherent 
strategy for its systematic development."  As a first step, they recommended an 
RFA to "jump-start" research in each of the three priority areas.  With this 
current RFA, NIMH and NIDA begin a long-term commitment to translational 
behavioral science research.  Some researchers, working singly or in small 
groups, have already accomplished significant research of this nature, to a 
degree that augurs the significant potential value of this approach.  At the 
current time, however, there is a clear need to foster a significant increase in 
collaborative efforts among basic and clinical researchers in order to realize 
the fullest potential of translational research.

The RFA is designed to address the needs of investigators at all stages in the 
collaborative research process.  For investigators who are just beginning to 
explore translational research questions, there is the networking R21 grant.  
For investigators who have initiated some collaborative partnerships and want to 
build a translational research capability, there is the developmental R21 grant.  
For investigators who have a specific translational research question, there is 
the R01 research project grant or the investigator-initiated Collaborative R01.  
Each of these mechanisms will be discussed below.
 
General Characteristics

Regardless of mechanism, all applications to this RFA must demonstrate that a 
research partnership between basic behavioral scientists and clinical and/or 
services researchers exists or will be developed and nurtured.  The minimum 
collaborative arrangement would thus involve two investigators, although larger 
groups of actual and potential collaborators are encouraged.  While the emphasis 
in this RFA is on behavioral science, networks that include relevant biological 
measures as integrative components are also encouraged, particularly from 
disciplines such as behavioral neuroscience and psychophysiology in which such 
integration is implicit.  Networks are to be conceptualized by the nature of the 
translational research goals and need not be limited by geographical or 
department boundaries.  Collaborations among different institutions are 
encouraged in view of the typical distinctions between basic sciences and 
clinical/services settings.  However, the applicants must show how communication 
will occur across these boundaries so that fully developed collaborative 
research partnerships can occur.

Networking R21 Grants

The primary purpose of networking R21 grants is to provide an avenue for basic 
and clinical investigators to initiate and explore the potential of research 
collaborations.  These research networks will have the following 
characteristics:

o  The purpose of this mechanism is to foster initial development of 
collaborative work; accordingly, investigators need not demonstrate any history 
of prior collaboration.  However, those factors in the investigators’ background 
and/or institutional circumstances that would facilitate success in 
collaboration should be clearly delineated.

o  A research network application must contain a cogent description of one or 
more specific topics in basic behavioral science, the clinical/services domains 
to which the basic science is to be applied, and a compelling justification for 
the potential of the research collaboration with respect to the translation of 
one or more basic science areas into clinical research.

o  Relevant areas of basic behavioral science can include models of behavior, 
cognition, social functioning, etc.; specific paradigms developed for the 
investigation of basic behavioral processes; and statistical models or 
methodologies.  In all cases, however, a strong knowledge base should already be 
available that is germane to the translational effort.
	
o  Networks should provide a clear plan for the development of the 
collaboration.  Such efforts could include travel among sites for informal 
meetings; workshops and small conferences; consultants; and analyses of extant 
data sets, using new methodologies or approaches.  The purpose of these 
activities will be to refine conceptual frameworks for organizing translational 
research and to identify which specific research questions show greatest promise 
for advancement.

o  Networks may also include pilot studies, with subjects drawn from clinical, 
high-risk, and/or non-clinical populations, in order to demonstrate feasibility 
of certain aspects of the research approaches and develop further translational 
research projects.

o  Networks may provide for salary support for faculty, research assistants, and 
other professional staff involved with the project.

o  Each network should present a description of the anticipated longer-term 
goals of the collaboration as it develops.  Such goals might variously include 
an application for a developmental grant (R21), an R01-based research 
collaboration, or a larger center mechanism.

Grants for Translational Research Development

The primary purpose of these larger R21 grants is to provide support for the 
beginning implementation of translational research capabilities and pilot 
projects.  As such, it is expected that the primary components of these projects 
will involve activities designed to foster such development.  These 
developmental activities will have the following characteristics:

o  The principal investigator must have demonstrated the capability to organize, 
administer, and direct the activity, and show a minimum time commitment of 25 
percent.  Other investigators must also allot a percentage of effort that is 
commensurate with their role in the project. 

o  A development project is expected to include a group of investigators who 
integrate ideas from diverse scientific and disciplinary realms.  While it is 
not necessary that all members of the project have independent research funding, 
investigators are expected to demonstrate a strong record of scientific 
productivity and innovation.  

o  The investigators are expected to develop a specific set of hypotheses 
related to translational research that define the mission of the project.  The 
project should address relevant theoretical and empirical literature in both the 
basic and clinical/services areas to be studied, and identify the goals of the 
translational research effort.

o  The goal of a project of this type is to support the development of a 
significant potential for conducting innovative translational behavioral science 
research.  Accordingly, the project should clearly describe the scope and goals 
of intended future work, including scientific goals and anticipated mechanisms 
of support (e.g., Collaborative R01 submissions, centers) that are anticipated 
to emerge from the developmental process.

o  The project will be expected to develop methodological and/or statistical 
strengths in a range of  areas.  Such methodologies could be developed initially 
in basic research areas, and then applied to issues in clinical or services 
research.

o  Projects should include plans for the common reduction, management, and 
analysis of data across multiple activities and sites.  Such work should be 
directed towards facilitation of comparing multiple data sets, and allowing 
direct comparisons (where relevant) of data bases from clinical and non-clinical 
populations.

o  As part of the developmental activity, seed money and start-up funds may be 
requested to support new, innovative pilot projects that reflect: (1) research 
that is needed to facilitate the development of basic behavioral science to 
prime its relevance to applied research; and (2) research in clinical and/or 
services domains that incorporates the theories and/or methods of basic 
behavioral science.

o  A developmental project must include plans for research apprenticeships.  
These should include opportunities for at least two young investigators to be 
mentored in one or more areas of specialization, and specifically address the 
application of basic research principles to clinical or services issues.  
Projects are expected to make maximum use of the variety of mechanisms available 
to foster the development of scientists with expertise in translational 
research.

Translational R01 Grants

The primary purpose of the R01 grants is to support fully implemented research 
projects with a translational focus.  Applications submitted with a single 
principal investigator will be expected to include one or more additional 
investigators forming a collaborative team that includes basic and 
clinical/services expertise, clearly defining the roles of all investigators in 
the translational research; for investigators at multiple institutions, the 
collaborative arrangements will typically be indicated via one or more 
consortium/subcontract arrangements.  The NIMH Collaborative R01 mechanism may 
also be used for investigators at a number of institutional sites, with a 
separate principal investigator for each constituent R01 application.  These 
research projects will have the following characteristics:

o  Translational grants must include one or more components of basic behavioral 
science.  The inclusion of relevant physiological measures, in addition to 
concepts, paradigms, and theories drawn from basic behavioral science, is 
encouraged but not required.

o  The principal investigator of a single-R01 project may be an individual with 
a primary research background in either basic or clinical/services areas.  
Submissions using the Collaborative R01 mechanism may include one or more 
separate R01 applications in each of the basic and clinical/services domains.

o  The clinical or services component of the proposed application may include 
any aspect of relevant work.  This component is to include research with patient 
populations, that is, studies conducted with persons diagnosed with mental 
disorders, including drug abuse and addiction, or with organizations that 
provide mental health or drug abuse services.  The clinical/services research 
program will reflect the contributions of basic behavioral science, including 
concepts, principles, extant literatures, paradigms, measures, statistical 
approaches, etc.; integration of comparable work from neuroscience is also 
encouraged where appropriate. 

o  The clinical or services component of the proposed application must focus on 
populations in need of treatment or services for the symptoms and/or functional 
deficits associated with mental disorders and/or drug abuse.

o  The basic behavioral science component must represent a meaningful 
contribution to the overall program of research, rather than serving a limited 
consultative role.  Although not required, this component could include an 
active program of experimentation, methodological or statistical development, or 
other scientific work that is relevant to the clinical/services application.  
These efforts might involve initial studies laying a necessary groundwork for 
projects with clinical/services populations, and/or studies to address basic 
research questions arising from results with samples drawn from clinical or 
services settings.  Basic behavioral studies typically involve non-clinical 
populations, but may also involve high-risk populations. 

o  Each application must demonstrate the ability to translate and integrate data 
between basic and clinical studies.  Each component must demonstrate the ability 
to inform, and be informed by, the results of the other component(s).

Research Topics

The following are examples of broad research topics that might be the focus of 
translational research.  This list is not meant to be comprehensive, nor are the 
examples meant to be exclusive of other topics.
 
o  Research pertaining to the factors that maintain the engagement of patients 
with treatments for mental disorders, including drug abuse or addiction, whether 
psychosocial or pharmacologic

o  Studies of cognitive, attentional, and/or emotional processes in attention-
deficit/hyperactivity disorder

o  Research devoted to an understanding of the nature of specific functional 
deficits in mental or drug abuse disorders (e.g., deficits in attention, memory, 
emotion-regulation, social interactions and relationships), and development of 
targeted interventions for rehabilitation and relapse prevention

o  Research regarding neurocognitive and emotional functioning related to 
severely disabling mental disorders or drug abuse, such as schizophrenia, 
bipolar illness, depression, and addiction

o  Studies of cultural factors involved in the diagnosis, prevention, treatment, 
and delivery of services in mental disorders, including drug abuse and addiction

o  Research regarding behavioral and neurodevelopmental factors in disorders 
characterized by impaired affiliative behavior and social functioning such as 
autism and schizophrenia

o  Studies of decision making as it affects the behavior of patients and 
providers in mental health or drug abuse services settings

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 are 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 are 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 the policy 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.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent 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 IC staff to estimate the 
potential review workload and plan the review.

The letter of intent is to be sent to the program staff listed under INQUIRIES 
by the letter of intent receipt date listed.

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) 435-0714, Email:  
GrantsInfo@nih.gov.  The application is also available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.


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, reviewers 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.

Applications that request more than $250,000 in any year must use the standard 
PHS 398 (rev. 4/98) application instructions.

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up to a 
total direct cost request of $250,000 per year.  (Applications that request more 
than $250,000 direct costs in any year must follow the traditional PHS 398 
application instructions.)  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 $250,000) 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 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.  NOTE:  Applications for R21 or R01 mechanisms 
that exceed $250,000 in direct costs in any one year must not be submitted in 
the modular format, and should be submitted following the traditional 
application instructions, including complete detailed budget pages and 
justification in the application.

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 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 3 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 3 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.

Applicants planning to submit an R01 application requesting $500,000 or more in 
direct costs for any year are advised that he or she must contact the Institute 
program staff before submitting the application, i.e., as plans for the study 
are being developed.  Note that this limit includes the overall total annual 
funding for Collaborative R01 applications.  Furthermore, the applicant must 
obtain agreement from the Institute staff that the Institute will accept the 
application for consideration for award.  Finally, the applicant must identify, 
in a cover letter sent with the application, the staff member and Institute who 
agreed to accept assignment of the application.

This policy requires an applicant to obtain agreement for acceptance of both any 
such application and any such subsequent amendment.  Refer to the NIH Guide for 
Grants and Contracts, March 20, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.

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 
(MH-01-005) 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, Developing 
Translational Research in Behavioral Science (MH-01-005), must be typed on line 
2 of the face page of the application form and the YES box must be marked. 

The sample modified mailing label is available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note this is 
in pdf format.  

Submit a signed, typewritten original of the application, including the 
Checklist, and 3 signed photocopies, in 1 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, 2 additional copies of the application must be sent 
to:

Bruce N. Cuthbert, Ph.D.
Adult Psychopathology and Prevention Research Branch
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6184, MSC 9625
Bethesda, MD 20892-9625
Rockville, MD 20852 (for express/courier service)

Applications must be received by the application receipt date listed in the 
heading of this RFA (April 11, 2001).  If an application is received after that 
date, it will be returned to the applicant without review.

The Center for Scientific Review (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 the NIMH or NIDA staff.  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 
NIMH in accordance with the review criteria stated below.  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 the applications under review, will 
be discussed, assigned a priority score, and receive a second level review by 
the respective Institute’s National Advisory Council.

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 to 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 and to the type of application, i.e., networking R21, developmental R21, 
translational R01?  Does the applicant acknowledge potential problem areas and 
consider alternative tactics?  Are the basic research components and clinical or 
services research questions suitably chosen to represent a feasible and 
potentially valuable translational project?

(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 principal investigator appropriately trained and well 
suited to carry out this work?  Does the collaborative network or team involve 
both basic and clinical/services expertise? Is the work proposed appropriate to 
the experience level of the principal investigator and collaborative 
researchers?

(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.

Schedule

Letter of Intent Receipt Date:    February 11, 2001
Application Receipt Date:         April 11, 2001
Peer Review Date:                 July 2001
Council Review:                   September 2001
Earliest Anticipated Start Date:  September 30, 2001

AWARD CRITERIA

Award criteria that will be used to make award decisions are:

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:

Bruce N. Cuthbert, Ph.D.
Adult Psychopathology and Prevention Research Branch
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6184, MSC 9625
Bethesda, MD 20892-9625
Telephone:  (301) 443-3728
FAX:  (301) 443-4611
Email:  bcuthber@mail.nih.gov

Lisa Onken, Ph.D.
Behavioral Treatment Development Branch
Division of Treatment Research and Development
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4123, MSC 9551
Bethesda, MD 20892-9551
Telephone:  (301) 443-0107
FAX:  (301) 443-8674
Email:  lo10n@nih.gov

Herbert Weingartner, Ph.D.
Behavioral Sciences Research Branch
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd., Room 4258, MSC 9555
Bethesda, MD 20892-9555
Telephone:  (301) 443-1263
FAX:  (301) 594-6043
Email:  hw6g@nih.gov

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3119, MSC 9541
Bethesda, MD 20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  gfleming@nida.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.242.  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 NIH 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 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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