BEHAVIORAL SCIENCE TRACK AWARD FOR RAPID TRANSITION (B/START)

RELEASE DATE:  October 20, 2003

PA NUMBER:  PAR-04-010  (Announcement being discontinued 
                          after expiration, see NOT-MH-05-015)

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. Accordingly, this funding opportunity 
expires on the date indicated below. A replacement R03 (PAR-06-141) funding 
opportunity announcements have been issued for the submission date of June 1, 2006 
and submission dates thereafter.

See NOT-OD-06-048 for information on May 1, 2006 Submission Date for AIDS and 
AIDS-related R03 and R21 Applications.

EXPIRATION DATE:  March 2, 2006

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:

National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATIONS:

National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.242

THIS PA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of the PA
o  Research Objectives
o  Mechanism(s) of Support
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Where to Send Inquiries
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS PA

This PA replaces PAR-00-119.

The National Institute of Mental Health (NIMH), through the issuance of this 
Program Announcement (PA), intends to facilitate the entry of new investigators 
into the field of behavioral science research to advance the mission of reducing 
mental illness and behavioral disorders through research.  NIMH invites newly 
independent investigators to submit applications for small-scale exploratory or 
pilot research projects related to the behavioral science mission of the NIMH.  
This includes basic research on psychological and behavioral processes (e.g., 
cognition, emotion, personality, social cognition), research incorporating neural 
and other biological approaches if the research has a primary focus on behavior, 
research on mental illness (risk factors, diagnosis, treatment, and prevention), 
and research on mental health services (e.g., organization, financing, delivery, 
and effectiveness; psychosocial rehabilitation, adherence).  Funding of B/START 
awards is relatively rapid, i.e., within approximately six months of the date of 
receipt of the application.

RESEARCH OBJECTIVES

Research areas relevant for support by NIMH can be found at the following URL:  
http://www.nimh.nih.gov/grants/program_contact.cfm.  To be appropriate for a 
B/START award, research in these areas must, in addition, be primarily focused on 
behavioral science research questions.  That is, research on neural, genetic, or 
other biological processes would be appropriate for a B/START award only if 
incorporated within a project whose overall emphasis is on understanding behavioral 
processes or outcomes.  Examples of the latter include individual mental function 
(e.g., cognition, emotion, personality); mental health disparities; developmental 
and environmental influences on behavior; behavioral or psychosocial factors in 
risk, treatment, and prevention of mental disorder; psychosocial rehabilitation; 
adherence; and behavioral factors in mental health service delivery.

MECHANISM OF SUPPORT

This PA will use the NIH Small Grant (R03) award mechanism.  As an applicant you 
will be solely responsible for planning, directing, and executing the proposed 
project.  The total project period for a B/START application may not exceed one 
year.  The total direct costs for the project may not exceed $50,000.  Grant funds 
may be used for expenses clearly related and necessary to conduct the research 
project, including both direct costs that can be specifically identified with the 
project plus allowable facilities and administrative (F&A) costs of the 
institution.  Replacement of the Principal Investigator on a B/START award is not 
permitted.  Transfer of a B/START award with the Principal Investigator to another 
institution for the remainder of the grant period may be requested.  B/START awards 
are not renewable.  If a B/START application is unsuccessful in obtaining funding 
on the first submission, it may be revised (amended) and resubmitted one time.  
Additional revision and resubmission of a B/START application is not permitted.

This PA uses just-in-time concepts.  It also uses the modular budgeting format. 
(see http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, 
B/START applications may request up to two modules of $25,000 direct costs each.

Because B/START grants have special eligibility requirements, application formats, 
and review criteria, applicants are strongly encouraged to consult with program 
staff (listed under WHERE TO SEND INQUIRIES) prior to submitting an application.

There are alternative mechanisms of support for individuals interested in pursuing 
periods of supervised training and career development activities.  Such individuals 
are encouraged to consider applying for NIMH individual postdoctoral fellowships or 
NIMH mentored career development awards.  Additional information regarding 
Institute-wide training initiatives and support mechanisms can be found at 
http://www.nimh.nih.gov/grants/training.cfm.

This program does not require cost sharing as defined in the current NIH Grants 
Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

ELIGIBLE INSTITUTIONS

You may submit application(s) if your institution has any of the following 
characteristics:

o  For-profit or non-profit organizations
o  Public or private institutions, such as universities, colleges, hospitals, and 
laboratories
o  Units of State and local governments
o  Eligible agencies of the Federal government
o  Domestic or foreign institutions/organizations
o  Faith-based or community-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

To be eligible for a B/START award, the proposed Principal Investigator must be 
independent of a mentor at the time of award, but be in the beginning stages of 
his/her research career (typically not more than five years from receipt of the 
doctorate or, if applicable, from the end of postdoctoral training).  If the 
applicant is in the final stages of training, s/he may apply, but no B/START award 
will be made to individuals still in training status.  The proposed Principal 
Investigator may not have been designated previously as Principal Investigator on 
any PHS-supported research or career grant (except a dissertation research grant) 
or have received similar support from another federal agency, e.g., the National 
Science Foundation.  However, previous funding as a trainee through the National 
Research Service Award (NRSA) program (i.e., Institutional Training Grant or 
Individual Fellowship), or through training support from another agency, is 
permissible.

Individuals from underrepresented racial and ethnic groups as well as individuals 
with disabilities are always encouraged to apply for NIH programs.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this PA and welcome the opportunity to answer 
questions from potential applicants.  Inquiries may fall into three areas:  
scientific/research, peer review, and financial or grants management issues:

o  Direct your questions about scientific/research issues to:

Mary Ellen Oliveri, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7220, MSC 9651
Bethesda, MD  20892-9651
Telephone:  (301) 443-3942
FAX:  (301) 443-9876
Email:  moliveri@nih.gov

Emeline M. Otey, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6186, MSC 9624
Bethesda, MD  20892-9625
Telephone:  (301) 443-3728
FAX:  (301) 443-4611
Email:  eotey@nih.gov

Enid Light, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD  20892-9635
Telephone:  (301) 443-1185
FAX:  (301) 594-6784
Email:  elight@nih.gov

o  Direct your questions about peer review issues to:

Michael Kozak, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9608
Bethesda, MD  20892-9608
Telephone:  (301) 443-1340
FAX:  (301) 594-0702
Email:  kozakm@mail.nih.gov

o  Direct your questions about financial or grants management matters to:

Ms. Carol J. Robinson
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda, MD  20892-9605
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3858
FAX:  (301) 443-6885
Email:  crobinso@mail.nih.gov

SUBMITTING AN APPLICATION

Prior to submitting an application, investigators are strongly encouraged to 
contact the program contacts listed under WHERE TO SEND INQUIRIES in order to 
assess the responsiveness of their proposed project to the mission of NIMH and to 
the goals of this PA.  Applications judged not to be responsive or not 
appropriately focused on mental-health-relevant behavioral processes and research 
questions (as addressed in PURPOSE and RESEARCH OBJECTIVES) may be returned to the 
applicant without review.

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet 
(D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier 
when applying for Federal grants or cooperative agreements. The DUNS number can be 
obtained by calling (866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of 
the face page of the PHS 398 form. The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.  
For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: 
GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES:  For B/STARTs, there is an exception to the standard 
deadlines as noted at: http://grants.nih.gov/grants/dates.htm.  In order to permit 
expedited funding, revised (amended) applications are due on the same dates as new 
applications (February 1, June 1, and October 1).  (As noted in MECHANISM OF 
SUPPORT, B/STARTs are allowed one revision only.)  

SPECIAL INSTRUCTIONS FOR A B/START APPLICATION:  All instructions for the PHS 398 
(rev. 5/2001) must be followed, with these exceptions:

o The title, “Behavioral Science Track Award for Rapid Transition (B/START),” and 
number of the program announcement (PAR-04-010) must be typed on line 2 of the face 
page of the application form and the YES box must be marked.

o  For revised (amended) applications, the Introduction to Revised Application must 
not exceed one page.

o  Sections a-d of the Research Plan must not exceed seven pages in total.

o  Appendix.  The appendix may include original, glossy photographs or color images 
provided that a photocopy (may be reduced in size) is also included within the page 
limits of the research plan.  No publications or other printed material, with the 
exception of pre-printed questionnaires or surveys, may be included in the 
appendix.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  B/START applications must be 
submitted in modular format.  The modular grant format simplifies the preparation 
of the budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the research 
grant application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular budgets.  Additional information on modular grants 
is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

For the B/START, applicants may request up to two modules (maximum of $50,000 
direct costs) for a period of one year.

SENDING AN APPLICATION TO THE NIH:  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 application applicants must simultaneously 
send two complete copies to:

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD  20892-9609
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-3367
FAX:  (301) 443-4720
Email:  jnoronha@mail.nih.gov

APPLICATION PROCESSING:  Applications must be mailed on or before the applicable 
receipt date (see APPLICATION RECEIPT DATES).  The Center for Scientific Review 
(CSR) will not accept any application in response to this PA 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 a 
substantial revision of an application already reviewed, but such application must 
include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 8 
weeks.

PEER REVIEW PROCESS

B/START applications are evaluated for scientific and technical merit by 
appropriate reviewers selected by NIMH in accordance with NIH peer review 
procedures.

REVIEW CRITERIA

The B/START award is a mechanism for pilot or preliminary research conducted by 
investigators new to the grant process.  Because of the restricted length of the 
research plan, a B/START application will not have the same level of detail or 
extensive discussion found in R01 applications.  Accordingly, reviewers should 
evaluate the overall conceptual framework, general approach to the problem, and 
promise of the application, placing less emphasis on methodological details and 
other indicators traditionally used in evaluating scientific merit.  Supportive 
preliminary data are not required.

Reviewers will evaluate the following aspects of B/START applications:

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

Reviewers will address and consider each of these criteria in assigning an 
application’s overall score, weighting them as appropriate for each application.  
An application does not need to be strong in all categories to be judged worthy of 
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?

(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?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, the following will 
be considered in the determination of scientific merit and the priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human subjects 
and protections from research risk relating to their participation in the proposed 
research will be assessed. (See criteria included in the section on Federal 
Citations, below).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  The adequacy of plans to 
include subjects from both genders, all racial and ethnic groups (and subgroups), 
and children as appropriate for the scientific goals of the research will be 
assessed.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals are to be 
used in the project, the five items described under Section f of the PHS 398 
research grant application instructions (rev. 5/2001) will be assessed.

ADDITIONAL CONSIDERATIONS

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

AWARD CRITERIA

The following will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review
o  Appropriateness to the goals of the B/START program
o  Availability of funds
o  Program priority

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that applications 
and proposals involving human subjects must be evaluated with reference to the 
risks to the subjects, the adequacy of protection against these risks, the 
potential benefits of the research to the subjects and others, and the importance 
of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for all 
types of clinical trials, including physiologic, toxicity, and dose-finding studies 
(phase I), efficacy studies (phase II), efficacy, effectiveness and comparative 
trials (phase III).  The establishment of data and safety monitoring boards (DSMBs) 
is required for multi-site clinical trials involving interventions that entail 
potential risk to the participants (NIH Policy for Data and Safety Monitoring, NIH 
Guide for Grants and Contracts, June 12, 1998:  
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  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 clinical research projects unless a clear and 
compelling 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 "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts on 
October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates:  the use of an NIH definition of clinical research; 
updated racial and ethnic categories in compliance with the new OMB standards; 
clarification of language governing NIH-defined Phase III clinical trials 
consistent with the new PHS Form 398; and updated roles and responsibilities of NIH 
staff and the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that:  a) all applications or proposals and/or 
protocols must 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) investigators must report annual accrual and 
progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic 
group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  The 
NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH policy 
requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects.  
You will find this policy announcement in the NIH Guide for Grants and Contracts 
Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only research 
using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry 
will be eligible for Federal funding (see http://escr.nih.gov).  It is the 
responsibility of the applicant to provide, in the project description and 
elsewhere in the application as appropriate, the official NIH identifier(s)for the 
hESC line(s)to be used in the proposed research.  Applications that do not provide 
this information will be returned without review.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The Office 
of Management and Budget (OMB) Circular A-110 has been revised to provide public 
access to research data through the Freedom of Information Act (FOIA) under some 
circumstances.  Data that are (1) first produced in a project that is supported in 
whole or in part with Federal funds and (2) cited publicly and officially by a 
Federal agency in support of an action that has the force and effect of law (i.e., 
a regulation) may be accessed through FOIA.  It is important for applicants to 
understand the basic scope of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public archive, 
which can provide protections for the data and manage the distribution for an 
indefinite period of time.  If so, the application should include a description of 
the archiving plan in the study design and include information about this in the 
budget justification section of the application.  In addition, applicants should 
think about how to structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modifications to the 
“Standards for Privacy of Individually Identifiable Health Information,” the 
“Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal regulation under 
the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that 
governs the protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR).  Those who 
must comply with the Privacy Rule (classified under the Rule as “covered entities”) 
must do so by April 14, 2003 (with the exception of small health plans which have 
an extra year to comply).

Decisions about applicability and implementation of the Privacy Rule reside with 
the researcher and his/her institution.  The OCR website (http://www.hhs.gov/ocr) 
provides information on the Privacy Rule, including a complete Regulation Text and 
a set of decision tools on “Am I a covered entity?”  Information on the impact of 
the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts can be found 
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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.  Furthermore, we caution reviewers that 
their anonymity may be compromised when they directly access an Internet site.

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 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.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health Systems 
Agency review.  Awards are made under the authorization of Sections 301 and 405 of 
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All awards are subject to the 
terms and conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace 
and discourage the 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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