Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Mental Health (NIMH) Office of Research on Women’s Health (ORWH)
Funding Opportunity Title	Competitive Revision Applications for Research on Neural Processes Underlying Sex Differences Related to Risk and Resilience for Mental Illness (P50)
Activity Code	P50 Specialized Center
Announcement Type	New
Related Notices	February 3, 2012 - See Notice NOT-MH-12-016. Frequently Asked Questions (FAQs) for this RFA have been developed.
Funding Opportunity Announcement (FOA) Number	RFA-MH-13-022
Companion FOA	RFA-MH-13-020, R01 Research Project Grant RFA-MH-13-021, R21 Exploratory/Developmental Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.242
FOA Purpose	This Funding Opportunity Announcement (FOA) seeks to support basic and translational research on the neurobiology of sex differences. Specifically, NIMH and ORWH solicit revision applications (formerly called competitive supplement applications) that explicitly test hypotheses regarding neural mechanisms underlying sex differences relevant to mental health. Applications should articulate a strong rationale for how the proposed project will significantly advance our understanding of the etiology and/or underlying pathophysiology of mental disorders in males and females. This FOA is limited to revision applications to currently active NIMH-supported P50 grants. Revision applications will provide funds for 1) recruiting additional subjects to provide enough power to address hypotheses about sex differences or 2) thorough analyses of pre-existing data where sex specific analyses were not initially included, and power is sufficient.

Posted Date	December 13, 2011
Letter of Intent Due Date	February 13, 2012
Application Due Date(s)	March 13, 2012
AIDS Application Due Date(s)	Not applicable
Scientific Merit Review	July 2012
Advisory Council Review	October 2012
Earliest Start Date(s)	January 2013
Expiration Date	March 14, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institute of Mental Health (NIMH) and Office of Research on Women's Health (ORWH), National Institutes of Health, seeks to support basic and translational research on the neurobiology of sex differences. Specifically, NIMH is encouraging revision applications to augment currently active NIMH Specialized Center (P50) grants. Revision applications should explicitly test hypotheses regarding neural mechanisms underlying sex differences relevant to mental health. Applications should articulate a strong rationale for how the proposed project will significantly advance our understanding of the etiology and/or underlying pathophysiology of mental disorders in males and females.

Research supported by this initiative will aim to understand how interactions among sex chromosomes, steroid hormones and environment shape sexually dimorphic neural pathways and behavior. Research projects funded under this FOA will aim to advance our understanding of how sexual dimorphisms influence clinical symptoms and age of onset of mental disorders. Periods of developmental divergence between the sexes, periods of rapid developmental change, and periods during which environmental influences are particularly strong present an opportunity for understanding sex-specific neurodevelopmental trajectories. As a result, studies testing developmental questions are strongly encouraged under this funding opportunity. Genetic variants with known associations to mental illness offer an opportunity to explore how genetic risk is linked to changes in brain function and circuitry. Sex differences in the prevalence and symptom profiles of mental disorders suggest sex differences in genetic risk. Therefore, studies investigating sex differences in genotype association or gene expression are encouraged under this funding opportunity. Applications investigating sex-specific gene associations in existing samples would be appropriate for this FOA, if the proposed questions were not part of the original planned analyses or specific aims of the parent study. Revision applications may focus exclusively on one sex if the intent is to supplement parent projects in which the chosen sex was under-represented or excluded, with the provision that the additional subjects must provide sufficient statistical power to test specific aims regarding sex differences.

Background

The NIMH has defined four overarching objectives in a Strategic Plan designed to carry out our mission of transforming the understanding and treatment of mental illnesses through basic and clinical research. Two Strategic Objectives are directly addressed by this FOA. The first, to promote discovery in the brain and behavioral sciences to fuel research on the causes of mental disorders, is met through basic, translational and clinical research that investigates genetic, neurobiological, behavioral, environmental and experiential factors in the etiology of disorders. The second objective focuses on understanding where, when and how to intervene by charting the trajectories of mental disorders over the lifespan in an effort to identify appropriate points of intervention to hasten recovery or prevent onset of illness.

An individual’s sex can influence susceptibility, prevalence, and age of onset for psychiatric disorders. Disorders that emerge early in development, such as autism, ADHD, Tourette Syndrome, and early-onset schizophrenia, tend to be more prevalent in males. Disorders with onset in adolescence or adulthood, such as major depression, anxiety disorders, and eating disorders, are more prevalent in females. Despite these clear epidemiological trends, very little is known about the precise timing, neural circuitry, or mechanisms underlying the expression of sex differences in mental disorders.

Sex differences have been largely overlooked in many research studies because of prevailing practices and biases in the field (Cahill, 2010; Nature, 2010; Office of Research on Women’s Health, 2010). Sex is often not considered in analyses, frequently due to a lack of power to address this question. Animal research studies frequently include only one sex in their experimental designs. Also lacking are theoretical models of disease that attempt to explain how neurobiological sex differences interact with other biological or environmental factors to confer risk and resilience for mental disorders. Moreover, because sex differences may be one factor underlying individual differences in response to treatments and interventions, research on sex differences related to the etiology of mental disorders may provide information fundamental to the development of personalized interventions.

Objectives

Sex differences are often driven by organizational effects during early brain development or activational effects related to variation in circulating hormone levels. A significant area of research concerns the precise timing of sex-specific genetic, epigenetic, and hormonal events during neurodevelopment. This FOA encourages applications that focus on interactions between such events and the resulting long-lasting sexual dimorphisms in cognitive, affective or social function. Research using animal and/or human subjects is encouraged.

One major objective of this initiative is to encourage researchers who have not previously focused on sex differences to include sex as a factor in their designs and analyses. Another major goal is to stimulate the development of conceptual frameworks that hypothesize how sex influences risk for mental illness. It is expected that findings from these investigations will enhance our ability to predict, diagnose, and intervene in mental disorders. Because the intent of this FOA is to foster new approaches emphasizing neuronal mechanisms rather than existing lines of investigation, the FOA emphasizes exploratory, high-risk, and potentially groundbreaking studies.

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

• Identification of sex-specific biomarkers (e.g., genomic, epigenomic, proteomic, neurophysiologic, neuroanatomical, and behavioral) for mental disorders that may illuminate sex-specific risk or protective processes.
• Cellular, molecular, and physiological studies to identify differences in microcircuitry, synaptic function, and susceptibility to sexually dimorphic modulation.
• Studies of sex differences in the modifiability of neuronal and circuit function across the lifespan, including clinically relevant perturbations.
• Studies examining how the prenatal environment interacts with postnatal experience to shape sex differences in behavior, brain structure and function.
• Studies examining the degree to which non-hormonal factors (e.g. neurotransmitters) may be sexually dimorphic or influence the development of sex differences in brain and behavior.
• State of the art techniques (e.g., induced pluripotent stem cells, optogenetics, or the four core genotype mouse model) to identify mechanisms contributing to sex differences in neurodevelopment and functional activation of relevant brain circuitry.
• The use of wild type or genetically-manipulated male and female animals to examine sex differences in brain structure and function, behavior, neuro/gliogenesis, and neuronal plasticity.
• Analysis of allele-specific expression differences in the development of sexually dimorphic physiologic and behavioral outcomes relevant to mental disorders.
• Brain imaging studies to identify relationships between sexual dimorphisms in brain structure, connectivity, or function and differences in cognition, affect, or social behavior.
• Behavioral and imaging studies of human patients with sex chromosomal aneuploidies.
• Studies using human post-mortem tissue to examine sex differences in gene transcription and expression in normative and pathological development.
• Studies of neural mechanisms of sex differences in the age of onset and clinical symptoms of mental disorders.
• Brain mechanisms contributing to sex differences in treatment effectiveness for mental disorders to inform future development of novel, personalized treatments.
• Secondary analyses of existing longitudinal imaging data-sets to address sex differences in brain development and connectivity patterns, especially in individuals at risk for mental disorders.

The description of the research project should include concrete indicators of progress and how these indicators will be used to inform the next phase of research on sex differences in mental health. Appropriate indicators may include, but are not limited to, recruitment schedules, interim data analyses, and/or a timeline for administrative and scientific accomplishments. Progress indicators should be included in each annual progress report and as part of the final report for the grant.

Although a formal data sharing plan is not required for applications submitted in response to this FOA, applicants are strongly encouraged to consider and should address data sharing in the application. Data collection, data description, and management procedures should be designed and piloted with future data sharing in mind (e.g., development of a data dictionary, data quality assurance procedures, and/or inclusion of relevant language in consent forms to allow future data sharing where appropriate).

Responsive applications must include both males and females, or provide evidence that exclusive focus on one sex is justified because the chosen sex was under-represented or excluded in the parent grant and the additional subjects will provide sufficient statistical power to test specific aims regarding sex differences. Specific aims must explicitly test hypotheses regarding sex differences. Hypotheses must address neural mechanisms and not focus solely on behavioral or epidemiological outcomes. Relevant applications must consider behaviors related to mental disorders and/or address how sexually dimorphic neural processes confer risk or impact resilience for mental disorders. Responsive applications are also required to articulate a strong rationale for how the proposed project will significantly advance our understanding of the etiology and/or underlying pathophysiology of mental disorders. The NIMH will decline applications that are not considered central to the NIMH mission and research priorities. Applications that focus on reproductive behaviors, aggression outside of the context of serious mental illness, or primary sensorimotor processing will not be considered responsive to this announcement. Applicants are strongly encouraged to consult the appropriate program official, listed in Section VII, to discuss the relevance of their proposed work to the NIMH mission as well as to ensure that proposed studies do not duplicate projects currently supported.

References

Cahill, L. (2010). Sex influences on brain and emotional memory: the burden of proof has shifted. Prog Brain Res, 186, 29-40).

Nature (2010). Putting Gender on the Agenda, 465, 665.

Office of Research on Women’s Health (2010). Strategic Plan for 2020, Vol II, 27-32 and 237-241.

Funding Instrument	Grant
Application Types Allowed	Revision P50 applications from investigators with active P50 research project awards issued by NIMH The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The NIMH and ORWH intend to commit approximately $3,700,000 in FY 2013 to fund up to 10 grants in response to this FOA and the companion announcements.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project. Applicants must submit a budget using the same budget format as was used for the parent award.
Award Project Period	The total project period for an application submitted in response to this FOA may not exceed two years. Applicants may request support for up to 2 years, not to exceed the remaining number of years on the parent grant.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

To be eligible, the parent award on which the revision application is based must be an active NIMH P50 at the time the revision application is submitted. The project period of the revision application may not extend beyond that of the parent award. If a no-cost extension is needed to complete the work to be proposed in the revision, the no-cost extension must be in place before the application is submitted.

For all revision applications, the Project Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must be the same as the PD(s)/PI(s) on the parent award. For revision applications to multiple PD(s)/PI(s) parent awards, the Contact PD(s)/PI(s) must be the PD(s)/PI(s0 listed on the parent award. A revision application does not allow a change in the Multiple PD(s)/PI(s) team nor a conversion from a single PD/PI to multiple PD(s)/PI(s).

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Stacia Friedman-Hill, PhD
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: 301-443-8458
Email: friedmans@mail.nih.gov

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

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

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Progress Indicators

The Research Strategy section should describe concrete indicators of progress toward the research project objectives. These can include specific and feasible measures of progress, potential data sources, and a timeline for major milestones. The measures included should assess the scientific accomplishments, both yearly and overall, of the research project. This should be included within the page limit of the Research Strategy. Progress indicators should be included in each annual progress report and as part of the final report of the grant.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

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 only as described in the NIH Grants Policy Statement.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applications should include a 1-page Introduction that describes the nature of the revision and how it will influence the specific aims, research design, and methods of the parent grant.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the study focus on neurobiological systems relevant to human mental disorders? Does the research project further the understanding of the neural mechanisms by which sex differences confer risk for or influence on resilience to mental illnesses? Will the research project lead to greater understanding of how interactions among sex chromosomes, steroid hormones, and environment shape sexually dimorphic neural pathways and behavior? Will the research project lead to identification/clarification of sexually-dimorphic points of vulnerability and developmental divergence? Does the research project address how sex differences in neurodevelopment confer vulnerability or protection in individuals at familial/genetic risk for mental disorders? Will this research facilitate improved understanding of how sexual dimorphisms influence the age of onset and clinical symptoms of mental disorders? Will the research project lay the foundation for future research to improve personalized prevention and interventions?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the application develop or test novel technologies that will facilitate the measurement or analysis of sex specific neural mechanisms such as techniques for visualization and manipulation of in vivo cellular function; novel methods for in vivo examination of epigenetic influences, especially in human brain tissue; new molecular and genetic approaches to study the effect of developmental stage, experience, and hormones?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the study have sufficient power to test hypotheses regarding sex differences? Does the study include both male and female subjects (humans or animals)? Is the evaluation plan well-defined, including (1) specific and feasible measures of progress, (2) adequate and available data sources, and (3) a timeline for major milestones?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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. More information is provided at Award Conditions and Information for NIH Grants.

Not Applicable.

When multiple years are involved, 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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Stacia Friedman-Hill, 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) 443-8458
Email: friedmans@mail.nih.gov

Janine Simmons, M.D., Ph.D
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7203, MSC 9645
Bethesda, MD 20892-9645
Telephone: (301) 443-1576
Email: simmonsj@mail.nih.gov

Lisa Begg, Dr.P.H., R.N.
Office of Research on Women's Health
National Institutes of Health
6707 Democracy Boulevard, Suite 400, MSC 5484
Bethesda, MD 20817
Telephone: (301) 496-7853
FAX: (301) 402-1798
Email: begg@od.nih.gov

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
Email: armstrda@mail.nih.gov

Rebecca Claycamp, MS, CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
Email: rclaycam@mail.nih.gov

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