Part I Overview Information


Department of Health and Human Services

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/)

Title:
  Biobehavioral Research Awards for Innovative New Scientists (BRAINS) (R01)

Announcement Type
New

Request for Applications (RFA) Number: RFA-MH-09-100

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release/Posted Date: October 30, 2008
Opening Date:  January 5, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 5, 2009
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s):  February 3, 2009
Peer Review Date(s):  May/June 2009
Council Review Date(s): August 2009
Earliest Anticipated Start Date(s):  September 30, 2009
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: February 4, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives


Section II. Award Information

1. Mechanism of Support

2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information

2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for recovery, prevention, and cure.  An essential element of this mission is the support and career promotion of the future generation of exceptionally talented and creative new scientists who will transform the understanding and treatment of mental illnesses and enable NIMH to fulfill its vision of a world in which mental illnesses are prevented and cured.  The NIMH supports a number of training and fellowship programs for pre and postdoctoral training, and mentored career development awards for faculty in the early stages of their career development.  However, even with these career development mechanisms in place, to fulfill its mission of assuring a cadre of productive, innovative mental health investigators for the future, NIMH needs to initiate further imaginative programs to identify and inspire the best new investigators and facilitate their establishing vibrant, independent research programs in areas relevant to the mission of the NIMH.

Research Goals and Scope

Increasing evidence suggests that mental disorders can be studied as developmental brain disorders.  As articulated in a recent Report of the National Advisory Mental Health Council’s Workgroup: Transformative Neurodevelopmental Research in Mental Illness, greater understanding of the developmental origins of mental illness offers hope that new diagnostic methods and better treatments will substantially reduce or eliminate illnesses such as anxiety, attention deficit hyperactivity disorder (ADHD), autism, bipolar illness, depression, and schizophrenia.  This report identified as an important impediment to progress the disciplinary and intellectual barriers between the current fields of developmental neurobiology, developmental psychobiology, developmental psychology, and developmental psychopathology.  Each of these disciplines offers important insights on the normal and abnormal development of brain and behavior, but too few individuals are trained to cross these disciplines to explore the neural basis of behavioral development or the impact of behavioral experience on the formation of neural circuits.

To answer this challenge NIMH seeks to support a cadre of early stage basic, translational, and clinical investigators who use theories and tools drawn from diverse disciplines including bioinformatics, neurogenetics, cellular and molecular biology, physiology, psychology, neurology, psychiatry, and developmental epidemiology and developmental psychopathology to offer innovative new approaches that can cross levels of analysis and elucidate the underlying mechanisms of normal and abnormal brain development.  Increasingly, the boundaries between basic, translational, and clinical research are being overcome by new discoveries.  As just one example, the discovery of candidate genes for schizophrenia and autism raises numerous questions about how these genetic variations alter cortical development.  Pursuing these questions will not only inform our fundamental understanding of the specification of neural systems, it may identify new opportunities for intervention.

In order to explain how the healthy brain develops, how neurodevelopmental processes go awry in mental illness, and how to realign these neurodevelopmental processes on healthy trajectories, it is important that NIMH invests in research that spans individual genes to cells to neural systems and finally to patients and involves a number of model systems (i.e., stem cells, cell lines, animals, and humans).  Moreover, a full understanding of the developmental trajectories of childhood-onset mental illnesses requires studies with developing organisms such as flies, fish, rodents or non-human primates depending on the question being addressed.  Fundamental neuroscience is critical to learning about new developmental processes at the molecular, cellular, and systems levels.  As mental illness is a human problem, non-human translational studies should be designed to inform understanding of human illness.

In order to identify outstanding basic, translational and clinical investigators at the formative stages of their careers and assist them in launching innovative research programs with the potential to transform our understanding of the underlying mechanisms of mental illness and translate basic developmental research to the clinic, the NIMH is establishing a new program of R01 research grants intended for early career researchers who have not received their first R01 research grant.  This competition is expected to be highly competitive, and only a limited number of grants will be awarded per year.

Research programs supported by this funding opportunity seek to promote career advancement of the most highly creative and promising new scientists who are committed to enabling NIMH to fulfill its vision of a world in which mental illnesses are prevented and cured, and bring innovative, ground-breaking, and potentially risky research initiatives and thinking to transform the understanding and treatment of mental illnesses.  High priority is placed on projects that use integrative research approaches to investigate the neurobehavioral mechanisms that contribute to mental disorders and elucidate the trajectories of both typical and atypical neurodevelopment and optimal periods for intervention.  Special emphasis is placed on multi-disciplinary (e.g., biological and behavioral) research approaches, utilizing humans and/or model organisms that address the following priorities:

The R01 applications in this program are distinguished from most other R01 research grants in that the applications:  1) incorporate a statement of career goals relevant to the mission of the NIMH, 2) include a discussion of previous research experience and achievements in addition to the research proposal, 3) include active participation of an external advisory committee, and 4) require demonstration of the commitment by the institution to actively support the research program development of the Principal Investigator.  In this inaugural year, research projects proposed in response to this Funding Opportunity Announcement (FOA) will be expected to have a defined impact on understanding the developmental origins, trajectories, and effective treatment of mental illness.

It is anticipated that the BRAINS program would be evaluated on a continuing basis by NIMH program staff, to assess the impact of the program on the portfolio of the NIMH, as well as on the progression of the awardees' careers.  Metrics to be used include, but are not limited to:  publications (both numbers and impact factors); academic promotion of Principal Investigators; awards; invited talks at national/international symposia; students and postdoctoral fellows trained in the Principal Investigator's laboratory; and honors received by Principal Investigators; committee service of Principal Investigators; and subsequent grant support awarded.  Principal Investigators of awarded BRAINS grants will be requested to provide information for the evaluation and any subsequent program evaluations for a period of up to ten years after the award.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Research Project Grant (R01) award mechanism.  The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide).  It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm)Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.

2. Funds Available

The NIMH intends to commit $5,000,000 in total costs to fund up to 6 new grants in FY 2009.  An applicant may request a project period of up to five years and budget for direct costs up to $1.625 million with no more than $400,000 in any single year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.  Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation.  See NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign institutions are not eligible to apply.

Only one application per school or college within a university will be accepted.  For example, within a university, one application can be submitted from each of the schools of medicine, public health, arts and sciences, etc. If more than one application from the same grantee entity is submitted, all will be withdrawn from the review process.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support.  Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

To be eligible for this award, applicants must have a Ph.D., M.D., or equivalent graduate degree.

This Funding Opportunity Announcement will not utilize the multiple PI/PD option

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewal applications are not permitted in response to this FOA.

Only one application per school or college within a university will be accepted.  For example, within a university, one application can be submitted from each of the schools of medicine, public health, arts and sciences, etc..

Eligible Principal Investigators are individuals with faculty appointments that are tenure track or professional equivalent and who have fewer than eight years of experience beyond their last terminal degree (e.g., Ph.D., M.D. or equivalent) at the time of application or, for clinical investigators, fewer than five years beyond their last internship, residency, or fellowship.  If the applicant is at an institution/organization that does not have a tenure track, he or she should hold an equivalent appointment.  Ineligible individuals include federal employees, current and former Principal Investigators on NIH research projects (R01), sub-projects of program projects (P01) or research components of Center Grants (P50), or equivalent research grant awards.  Those selected for the NIMH award may hold other early career awards, such as those from the McKnight Foundation, Pew Charitable Trust, or The Searle Foundation.  Applicants will be expected to devote at least 50% time and effort to the award and have a long-term commitment to mental health research.  Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Applicants must have a research career and a long-term commitment to a career in the diagnosis, treatment and prevention of mental illnesses consistent with the core mission areas of the NIMH.  The NIMH will decline applications not considered central to either the mission or the research priorities of the NIMH as part of the initial evaluation for responsiveness.  Applicants are encouraged to discuss their research plans with an NIMH Program Officer prior to submission to ensure eligibility.

Applicants may not simultaneously submit identical/essentially identical applications under both this FOA and another PHS funding opportunity announcement.  Investigators who have another scientifically distinct R01 application pending at the time of the BRAINS receipt deadline, i.e., submitted October or November 5, 2008 for review at May 2009 Council, are eligible to submit a BRAINS application for a different project.  However, since the BRAINS award is designed for new investigators who do not have R01 support, individuals who receive a fundable score and accept funding for the regular R01 prior to the award of the BRAINS grant are not eligible to receive the BRAINS award.  The individual may defer activation of the regular R01 until after selection of the BRAINS awardees has been made.  If his or her BRAINS application is not chosen for funding, he/she may activate the regular R01.  If the BRAINS application is chosen for funding, the applicant will have to decide which grant to accept, but may not accept both.

Applicants are expected to devote at least 50% time and effort to the grant.  However, should the PI be successful in obtaining funding through another R01 or similar award, during the tenure of this grant, the percent effort on the BRAINS award may be negotiated with the NIMH program staff down to no less than 30%.  In addition, the awardees' departments are encouraged to provide an additional 25-30% release time commencing clinical, teaching, and administrative duties in order to allow the awardee to devote a larger percentage of time to research efforts.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only.  These are different than any DUNS number and CCR registration used by an applicant organization.  Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more.  Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH.  Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional.  A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., “Special Instructions,” regarding appropriate required budget component)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: January 5, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 5, 2009
Application Due Date(s): February 3, 2009
Peer Review Date(s): May/June 2009
Council Review Date(s):  August 2009
Earliest Anticipated Start Date(s): September 30, 2009

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Kathleen C. Anderson, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
6001 Executive Blvd, Room 6189 MSC 9617
Bethesda, MD 20892-9617
Telephone: (301) 443-5944
FAX: (301) 480-4415
Email:  kanders1@mail.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp  and follow Steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED.

In order to expedite the review, applicants are requested to notify the NIMH Referral Office by email (NIMHReferral@mail.nih.gov) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions


All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see the NIH Grants Policy Statement).

6. Other Submission Requirements and Information

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

The Research Plan is limited to ten pages.  All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Future Goals and Objectives and Biography

Two narrative presentation sections entitled “Future Goals and Objectives” and “Biography,” respectively, should be included in the application as attachments (Item 11, under 4.4 Other Project Information Component. The “Future Goals and Objectives” section (one page maximum) should briefly describe the career track vision and long-term research interests/objectives of the Principal Investigator with emphasis on how these interests/objectives relate to the discovery of the developmental origins of mental illness. The “Biography” section (two page maximum) should describe the applicant's scientific development from graduate school, the postdoctoral experience(s), through the present faculty position. For each training/research experience, the applicant should describe his/her role in the laboratory or project and cite relevant publications that resulted from the experience.

Bibliography & References Cited:  Limited to one page and should be attached to the Other Project Information Component. Note that the ten page limit for the Research Plan does not include the Literature Cited section. 

Research Plan

The Research Plan is limited to ten pages.  Applicants should skip the Specific Aims, Background and Significance, and Preliminary Studies sections and include only the Research Design and Methods section. The pdf file for the Research Design and Methods section should include the following sections within the 10-page limit, in the following order, with the headings shown:

Preliminary data are allowed but not required. Bibliographic citations (references), figures, and illustrations may be included, but must fit within the 10-page limit.

Advisory Committee

The Principal Investigator is expected to form an external advisory committee. Names of Advisory Committee members should not be listed in the application.  This FOA uses the just-in-time concept for the External Advisory Committee members.  The application should indicate the areas of scientific expertise and anticipated input, and any critical considerations in the selection of members, at the time of submission.  The Advisory Committee is expected to meet at least annually to provide ongoing assessment of the progress of the research; to discuss future research goals, aims, and ideas; and to provide research career guidance to the awardee during the five years of the grant.

NIMH suggests an Advisory Committee structure such as the following:  At least three scientists, two of whom are external to the Department, (one external to the University or Institution).  One member should have research expertise similar to that of the Principal Investigator, and one should be an individual who is expert in human or clinical studies and who can provide input into the translation of the research.  Discussion of the Advisory Committee should be included as part of the Field 5, Research and Design and Methods Attachment of the Research Plan.

Institutional Support

The Chair of the Department where the Principal Investigator holds the primary academic appointment should provide a letter (attached as a letter of support in the PHS398 Research Plan Component of the SF424 application, Item 16) describing any tangible research support that has been committed to the Principal Investigator. This may include start up packages provided to the investigator, salary commitment, protected time for research, space and equipment allocations, core facilities that will be made available without charge-back, specialized training and mini-sabbatical experiences to promote career enhancement, etc. In addition, the letter should discuss the departmental commitment to protected research time for the applicant.  The department is encouraged to provide release time so that the applicant will be able to devote 75% of his/her professional effort to research (See Section III.3. Other Special Eligibility Criteria) The strength of the institutional commitment will be considered a factor in the review of the application.

If a previous postdoctoral or research mentor remains in the same Institution as the Principal Investigator, a letter (attached as a letter of support, in the PHS398 Research Plan Component of the SF424 application, Item 16) should be included in the application and outline the respective roles of the Principal Investigator and the research mentor in the design and conduct of the proposed research. The research mentor should also indicate how the proposed research program is expected to be independent from the research directions of his/her laboratory.

Budget

Applicants may request up to five years and up to $1.625 million in total direct costs to be allocated according the research needs of the Principal Investigator but not to exceed $400,000 in direct costs in any single year.  These funds will be for research-related expenses. The Principal Investigator is encouraged to budget sufficient travel costs to present the results of the research at a variety of high-caliber technical meetings, at least one of which is devoted directly to mental health research and is widely attended by other NIMH grantees. A portion of the budget could include travel for external members of the advisory committee to meet yearly, in (See Grants Policy Statement). In addition, the Principal Investigator should budget for travel to the NIH campus in Bethesda, MD each year in years 3-5 to present a seminar or participate in a research symposium.

The Principal Investigator is expected to devote a minimum of 50% effort per year to the grant for the full five-year period (Section III.3).

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Is the potential impact of the proposed research exceptional, in terms of the magnitude of the impact and the size of the community affected?  If the applicant is attempting to verify a novel hypothesis, is it critical, for the field, that the hypothesis be verified or disproved?  Is the work paradigm shifting or if no paradigm exists will this project create one?  If the proposed work is successful does it have the potential to transform our understanding of the developmental origins of mental illness and translate basic developmental research to the clinic in order to prevent onset, improve diagnostic accuracy, and create cures?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs? Is the logic of the approach compelling despite the lack of experimental details? Has this methodology or hypothesis been tested before? Are the proposed methods/approach exceptionally innovative, unconventional?  Do the proposed methods/approach differ from what other investigators have attempted to do? Does the information in the timeline inspire confidence that the PI will be able to document progress in each year of the award and either complete the project or demonstrate that it is not feasible, despite good-faith efforts, during the term of the award? If the approach involves a high degree of risk, has the applicant adequately explained what he/she will do if the approach is unsuccessful?

Innovation:  Is the project original and innovative?  For example:  Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?  Is the hypothesis and/or the proposed methodology unconventional and exceptionally innovative?

Investigators: Are the PD(s)/PI(s) and other key personnel 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? Do(es) the PD(s)/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? Do the past achievements of the PI suggest that the investigator is exceptionally innovative and likely to make paradigm-shifting, high-impact discoveries relevant to neurodevelopment? If the PI does not have a history of doing exceptionally innovative, high-impact research, does the logic of the experimental plan suggest that there is some likelihood of success? Can the potential of the investigator to make important research contributions be assessed on the investigator’s future goals and biography sections of the application?  Is there potential for the investigator to profoundly transform our understanding of the underlying mechanisms of mental illness and translate developmental research to the clinic in order to prevent onset, improve diagnostic accuracy, and create cures?

Environment:  Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?  Is the strength of the Institutional support to the career advancement of Principal Investigator evident?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

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 the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

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 the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R)
 
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R). 

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”

Prior to the funding decision process, the applicant will be requested to name the Advisory Committee members, and ask each potential member to provide a letter outlining his/her expected role and the expertise to be provided to the Principal Investigator’s research and career experiences.  However, the names of the committee members should not be included in the application.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

A copy the meeting report from the designated Chair of the Advisory Committee, provided to the NIMH as part of the annual progress report of the grant, will be used by the NIMH in assessing progress on the individual grants, as well as in evaluating the program as a whole.

Section VII. Agency Contacts


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

1. Scientific/Research Contact(s):

Kathleen C. Anderson, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6189, MSC 9617
Bethesda, MD 20892-9617
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-5944
FAX:  (301) 480-4415
Email:  kanders1@mail.nih.gov

2. Peer Review Contact(s):

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone:  (301) 443-3534
FAX: (301) 443-4720
Email:  armstrda@mail.nih.gov

3. Financial/Grants Management Contact(s):

Rebecca Clayclamp, CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room, 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
FAX:  (301) 443-6885
Email:  rclaycam@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) 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). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 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 funding opportunity 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.

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 clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 SF424 (R&R) application; 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. 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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available 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 (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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification 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 HHS Office for Civil Rights (OCR).

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. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 FOA 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. 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 Part 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 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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