and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health
(NIMH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
Title: Novel Interventions for Neurodevelopmental Disorders
(R34)
Announcement Type
New
Request For Applications (RFA) Number: RFA-MH-09-020
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 weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
93.242
Key Dates
Release/Posted Date: March 7, 2008
Opening Date: May 17, 2008 (Earliest date an application may be submitted
to Grants.gov)
Letters of Intent Receipt Date(s): May
16, 2008
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 Submission/Receipt Date(s): June 17, 2008
Peer Review Date(s): October
2008
Council Review Date(s): January
2009
Earliest Anticipated Start Date(s): April
2009
Additional Information To Be
Available Date (Activation Date): Not Applicable
Expiration Date: June
18, 2008
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. Submission, 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 Contact(s)
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
Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to provide support for the development of novel efficacious interventions for neurodevelopmental disorders with the aim of improving various domains of functioning that are impaired across disorders and are altering developmental trajectories. It provides resources for evaluating the feasibility, tolerability, acceptability and safety of novel approaches, and for obtaining the preliminary data needed to support the development of a larger-scale clinical trial.The goal is to develop new treatment approaches with the potential for widespread, cost-effective application. Also of interest are innovative and theoretically sound intervention approaches that are currently in clinical use but which have not been adequately evaluated for safety and efficacy. Given that treatments are frequently symptom-focused, it is hoped that the development of novel approaches will offer potential for application for a given domain of functioning or impairment across disorders. Research to be supported under this FOA may include technical development, proof of principle projects, pilot studies, exploratory studies, and small scale efficacy trials, which may provide preliminary data, new methods, new treatment targets, and/or a foundation with which to pursue larger trials supported by subsequent grant application mechanisms such as the R01.
Background
For the purposes of this FOA, "neurodevelopmental disorders" are mental disorders that have their onset during the developmental period. These include, but are not limited to, autism spectrum disorders, childhood-onset schizophrenia, pediatric bipolar disorder, attention-deficit hyperactivity disorder (ADHD), Tourette syndrome, child- and adolescent-onset obsessive-compulsive disorder, and neurodevelopmental disorders with a known etiologic basis that have been associated with psychiatric symptomatology, such as Fragile X and velocardiofacial syndrome (22q deletion syndrome). In contrast to adult-onset disorders, neurodevelopmental disorders interfere with early skill acquisition and hold potential for eliciting a cascade of events with dire consequences for brain and behavioral development. Early deficits that impact attention, learning, social interaction, emotion regulation and other domains of functioning as well as additional symptoms characterizing the disorder, such as anxiety, obsessions, repetitive behaviors, or psychotic symptoms, are not only impairing in themselves, but may preclude normal environmental experiences. This may in turn further perturb experience-dependent brain organization. It is hoped that interventions directed toward normalizing functioning during childhood will maximize adaptive neuroplastic influences, while minimizing maladaptive neuroplastic effects. Thus, there is interest in assessing the impact of interventions at different levels, including both the level of clinical symptoms, and in parallel, the effects on underlying neurobiological aspects.
These disorders are characterized by phenotypic heterogeneity, high comorbidity and shared deficits/impairments. Not all children with a particular diagnosis manifest the same profile of symptoms and impairments, and these symptoms and impairments may well be shared across disorders. Examples include the frequent presence of attentional deficits and frank ADHD, debilitating anxiety, and obsessive-compulsive symptoms across disorders. Given the symptom overlap, high comorbidity, and fact that treatments tend to be symptom-focused, interventions developed for one disorder are frequently useful in treating children with other disorders.
Nosology in child and adolescent psychiatry and psychiatry in general is based on behavioral symptoms, rather than an comprehensive understanding of etiology or neurobiology. As a result, our current treatments are symptom-focused. Unraveling the pathophysiology of these complex disorders presents an enormous challenge, as it is likely that many, if not most, of these disorders involve cumulative and interactive effects of many genes with environmental determinants (e.g., perinatal exposures to infections with a pathogen such as HIV-1 or other agents) whose effects may vary with age. Nonetheless, based on the ability of the experience to influence brain development, it is believed that a variety of treatment approaches may synergistically impact both brain and behavioral development.
Most prevalent among the empirically supported treatments are pharmacologic and psychotherapeutic approaches. Medications most frequently are tested first in adults, then tried in children. Such an approach serves to decrease risks of adverse effects, but may also minimize opportunities for considering developmental neurobiology in pediatric drug development. Psychosocial approaches may include family therapy, behavioral management, cognitive-behavior therapy of various forms (e.g., exposure and response prevention) and multi-system interventions. Relatively less explored are nonpharmacologic physiological treatment approaches, cognitive training, nontraditional cognitive- and cognitive-behavioral treatment approaches, and approaches that use new technology to allow the rapid assessment of behaviors and adaptation of therapeutic modules to match an individual's needs. The emphasis of this FOA is on innovation and pursuing projects that hold promise for developing new approaches. It is understood that, as is often the case in research, a high level of innovation may entail higher risks of failing to find useful applications.
Research Scope
This funding opportunity is intended to stimulate the development of novel efficacious therapies targeted at one or more domains of functioning and impairment in neurodevelopmental disorders. These include, but are not limited to, executive functions such as attention, cognitive control and working memory, organizational skills and planning, mood and emotion regulation, social perception and cognition, and social interest and motivation, as well as positive symptoms such as anxiety, obsessions, repetitive behaviors, and psychosis.
Investigators should target one or more domains of functioning in a particular diagnostic group and address in their applications the rationale and potential for generalization of the novel treatment approach (with or without modification) to other disorders. Safety, compliance, or feasibility issues will, in some cases, favor the initial study of older subjects, e.g., adolescents, adults. Given the chronicity of these disorders, these age groups are, in themselves, appropriate candidates for study and new therapies. However, applications involving older subjects should discuss/touch on the implications of targeting their particular age group for broader applicability and/or eventually extending the treatment research downward in age.
This FOA is intended to support research in the earliest stages of treatment development. Applicants should explicate a clear conceptual link between relevant psychological or behavioral factors, the intervention components being proposed (including a description of the mechanism of action by which these components are hypothesized to have an effect), and their relationship to the outcomes that are being targeted. Research to be supported under this FOA may include pilot studies, exploratory studies, and small scale efficacy trials, which may provide preliminary data, new methods, new treatment targets, and/or a foundation with which to pursue larger trials supported by subsequent grant application mechanisms such as the R01. Research aims may include, but are not limited to, determination of dosing levels and duration; side effects and safety monitoring; demonstration that outcome measures have appropriate sensitivity to change in the target population; demonstration of feasibility (implementing the intervention and study procedures, evaluating attrition); and determination of sample sizes needed for larger trials.
Examples of types of applications that would fit the goals of this FOA include, but are not limited to:
Alternative and complementary treatment approaches will likely be better suited for submission to the National Center for Complementary and Alternative Medicine (NCCAM) and thus would not be considered responsive to this FOA. These approaches include mind-body techniques (e.g., meditation, mental healing, art therapy), vitamins and other dietary supplements, and manipulative and body-based practices (e.g., chiropractic manipulation, massage).
See Section
VIII, Other Information - Required Federal Citations, for policies
related to this announcement.
Section II. Award Information
1. Mechanism of Support
This Funding Opportunity Announcement (FOA) will use the NIMH Clinical
Exploratory/Developmental Research Grant (R34) 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 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.
Foreign applicants must complete and submit budget requests using the Research & Related Budget component.
2. Funds Available
The NIMH intends to commit approximately $2,500,000 in total costs in FY09 to support four to eight grants in response to this FOA and the companion R21/R33 FOA. The total project period for an application submitted in response to this funding opportunity may not exceed three years. Direct costs are limited to $450,000 over an R34 3-year period, with no more than $225,000 in direct costs allowed 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 NIMH provides support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
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
You may submit an application(s) if your institution/organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (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.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
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
Applicant organizations may submit more than
one application, provided each application is scientifically distinct. Resubmission
applications are not permitted in response to this FOA. R34
grant support is for new projects only; competing renewal applications will
not be accepted.
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, 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 eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
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 PD/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 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
301-710-0267, Email: [email protected].
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. There are fields within the SF424 (R&R) application components that, 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 is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include 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
Foreign Organizations (Non-domestic (non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
See Section IV.3.A for
details.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date: May 17, 2008 (Earliest date an application may be submitted
to Grants.gov)
Letters of Intent Receipt Date(s): May
16, 2008
Application Submission/Receipt Date(s): June
17, 2008
Peer Review Date(s): October
2008
Council Review Date(s): January
2009
Earliest Anticipated Start Date(s): April
2009
3.A.1. Letter of Intent
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:
Judy Rumsey, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6180, MSC 9617
Bethesda, MD 20892-9617
Telephone: (301) 443-9264
Fax:
(301) 480-4415
Email: [email protected]
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/Apply 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 [email protected] 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
submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application
is not submitted by the receipt 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: are necessary to conduct
the project, and 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 award.
The incurrence of pre-award costs in anticipation
of a new or renewal 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/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
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. 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:
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.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Indicate how the proposed project has specific relevance to the mission and objectives of the IC and has the potential for significantly advancing the health sciences in the United States.
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
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 NIMH in
accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH supported research
are to advance our understanding of biological systems, to improve the
control of disease, and to enhance health. In their written critiques,
reviewers will be asked to comment on each of the following criteria 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 an application does not need to be strong
in all categories to be judged likely to have major scientific impact
and thus deserve a high priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative
but is essential to move a field forward.
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? Does the intervention strategy fill an important need
or gap in our armamentarium of interventions for neurodevelopmental disorders? Does
the therapeutic approach hold promise for altering developmental trajectories? Does
the proposed therapy hold promise for application or extension to multiple
disorders? Does the approach offer potential for having a high clinical
impact, e.g., by stimulating new, even groundbreaking, treatment approaches
or dramatically improving patient functioning?
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? Do the study aims accomplish the prerequisites
for conducting a larger (e.g., R01) study that more definitively tests
the efficacy of the intervention? For applications designating multiple PDs/PIs, does
the Leadership Plan ensure that there will be sufficient coordination
and communication among the PDs/PIs? Are the administrative plans
for the management of the research project appropriate, including plans
for resolving conflicts?
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?
Investigators: Are the PD/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? Does the PD/PI(s) and investigative team bring complementary
and integrated expertise to the project (if applicable)?
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?
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 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 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.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
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/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.
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
When multiple years are involved, awardees will
be required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required
in the NIH
Grants Policy Statement.
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,
peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Judy Rumsey, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6180, MSC 9617
Bethesda, MD 20892-9617
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-9264
FAX: (301) 480-4415
Email: [email protected]
For inquiries regarding HIV-1 related research:
Pim Brouwers, Ph.D.
Division
of AIDS & Health
and Behavior Research
National Institute of Mental
Health
6001 Executive Boulevard, Room 6216,
MSC 9619
Bethesda, MD 20892-9619
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-4526
FAX:
(301) 443-6000
Email:
[email protected]
2. Peer Review Contacts:
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: [email protected]
3. Financial or Grants Management
Contacts:
Joy Knipple
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9659
Bethesda, MD 20892-9659
Telephone: 301-443-8811
FAX: 301-480-1956
Email: [email protected]
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 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 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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