It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) 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. 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 the 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

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals.More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

Recent studies indicate that there are 5.3 million adults over the age of 20 in the United States diagnosed with Autism Spectrum Disorders (ASD) and that about a half million youth with ASD will enter adulthood over the next decade. In recognition of the need for evidence-based ASD services across the lifespan, the Interagency Autism Coordinating Committee (IACC) Strategic Plan for ASD has articulated research objectives for adult and transition-age youth services across multiple domains. In response to the IACC strategic plan, NIMH previously issued two requests for applications (RFAs; RFA-MH-17-200 and RFA-MH-17-205). Applicants to this career enhancement award are encouraged to review these two RFAs for more information pertaining to NIMH research priorities in services research for transition-age youth and adults with ASD.

Among the growing number of studies developing and testing the effectiveness of services for people with Autism Spectrum Disorders (ASD), the vast majority have focused on children. Because the impairments associated with the core deficits of ASD typically last into adulthood, research focused on developing effective services for adults and transition-age youth with ASD is also needed. Adults with ASD are less likely to receive various types of services and more likely to have more and different needs for services than children. More investigators are needed to conduct research that provides an evidence base for policy makers, service systems, payors and other stakeholders involved in responding to the need for a range of empirically supported, effective, high-quality, cost-effective services among adults and transition-age youth with ASD.

The goal of this K18 initiative is to enhance research workforce capacity as rapidly as possible by supporting a program that will help established investigators in related or complementary fields to gain research expertise in ASD services for adults or transition-age youth. The purpose of enhancing workforce capacity is to increase the number and breadth of areas covered by funded NIMH Research Project Grants (RPGs) that address service needs related to the health and functioning of adults and transition-age youth with ASD.

The objective of this Career Enhancement Award for Experienced Investigators (K18) is to provide support for experienced scientists who either wish to broaden their scientific capabilities or to make changes in their research careers by acquiring new research skills or knowledge. The purpose of this Funding Opportunity Announcement (FOA) is to provide such investigators with support for an intensive period of mentored research experience to acquire new research capabilities in services for adults or transition-age youth with Autism Spectrum Disorders. In addition to preparing the awardee to apply for independent funding to conduct research on services for transition-age youth or adults with ASD, it is expected that this initiative will also lead to new research collaborations that could be competitive for future NIMH funding.

Applicants are expected to identify one or more research mentors with relevant expertise in applicant knowledge-gap areas. The mentor(s) must be established, well-qualified, and willing to support the applicant's short-term research career development experience. The candidate and the proposed mentor(s) should not already have established, longstanding collaborations at the time of the application. Candidates are expected to either establish new collaborative arrangements or strengthen and enhance relatively new or developing collaborations on a research project on services for transition-age youth and adults with ASD.

Examples of novel skill combinations that might result from the mentored training include, but are not limited to:

• training in transition-age/adult development and service needs for researchers with expertise in services for young children with ASD
• services research training for investigators with other types of of ASD research expertise
• training in ASD for candidates with a record of productivity in adult or transition-age youth mental health services research

This relatively short-term (12 to 24 months), intensive period of mentored research experience should expand the investigator's current expertise and lead to new knowledge and skills related to services research for transition-age youth or adults with ASD. The research career enhancement experience may be conducted in a different department within the candidate's home institution or in a different institutional setting from the location where the candidate holds his or her primary appointment. The research experience proposed must have the potential to substantially augment the research capabilities of the candidate at their institution and provide new research opportunities and benefits that would not be achievable through a collaborative research grant with the mentor(s). The research career enhancement experience should be tailored to the individual needs and level of experience of the candidate. The career enhancement plan should include (1) a didactic academic enrichment plan, e.g., coursework, seminars, journal clubs, etc., and (2) a small-scale research project focused on services for transition-age youth or adults with ASD. The research project is expected to expand the candidate's direct experience with individuals and services systems for the new age or diagnostic group.

Scale and Scope of the Research Project

This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development. Accordingly, examples of research projects include, but are not limited to:

Pilot studies in preparation for full scale R01 research on services for transition-age youth with ASD that will develop and test:

• Provider and systems-level strategies to ensure coordinated, continuous care during transition to adult services (e.g., interventions to increase provider attention to transition planning, strategies to develop cross-system collaboration, novel financing strategies to bridge from child and adult service systems).
• Approaches for enabling providers to tailor transition strategies to an individual's intellectual abilities, health and housing needs and key functional skills to eliminate disparities in the receipt of services and improve outcomes.
• Strategies for optimizing collaboration among education and other service systems (e.g., vocational rehabilitation, health care system, Social Security Administration, Medicaid, state-level agencies, independent living programs, etc.) to enable optimal independence and functioning.
• Approaches to reduce and prevent disparities in postsecondary education, functioning, health care access, and independent living, including disparities based on socioeconomic status, race or ethnicity, intellectual ability, or functional impairment.
• Strategies to prevent lapses in acquired skills and behaviors and to interrupt negative trajectories, including preventing or ameliorating contact with the criminal justice system, treating and managing comorbid medical and/or psychiatric disorders, reducing victimization, and improving housing outcomes.

Pilot studies in preparation for full scale R01 research on services for adults with ASD that will develop and test the effectiveness of:

• Specific services interventions (e.g., housing models; social- and independence-skills development programs; educational, vocational and employment programs and supports, etc.) for improving functional and behavioral outcomes among adults with ASD.
• Novel, existing, or adapted service delivery/coordination models in optimizing functional and health outcomes, independence, individual stability and continuity of care, and reducing disparities in access and utilization of services by adults with ASD.
• Combining and/or sequencing services (e.g., housing services, rehabilitation or compensatory strategies, individual or family support models, systems navigator models, etc.) in generalizing improvement in functioning and reducing negative outcomes (e.g., contacts with law enforcement; victimization; poor outcomes for comorbid conditions; unemployment, underemployment or social isolation; substance use, etc.)
• Provider- and systems-level strategies in facilitating receipt of services and coordination and continuity of care for adults with ASD (e.g., provider-targeted interventions to increase clinician attention to the universe of needs, organizational level interventions to develop cross-system collaboration among various aspects of the adult service systems, novel financing strategies to expand access to services).
• Strategies for identifying, treating and managing comorbid mental and/or physical disorders in adults with ASD.
• Strategies to identify undiagnosed ASD disorders in adulthood and engage those identified in services and supports in order to improve stability, behavioral and functional outcomes.
• Strategies to support individuals and families in accessing and navigating complex multi-sector systems of care, including increasing capacity to find or effectively advocate for services and to create informal supports and services for adults with ASD.

It is important that applicants conducting services intervention research develop their research plans to be consistent with the NIMH emphasis on an experimental therapeutics approach to intervention development and testing. The structure and budgetary constraints associated with this career enhancement award will limit the scope of the research that can be achieved. Applicants will need to address the feasibility of completing their project within these constraints. Prospective applicants are encouraged to contact the Scientific/Research Contact for additional guidance.

NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015).

NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders. By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies. NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response. NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions.

Note: This FOA is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA (RFA-MH-19-100).

Protection of Human Subjects: Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application's Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.)

On Thursday, August 9, 2018 at 12PM EDT the NIMH will conduct a one-time, pre-application technical assistance webinar for this funding opportunity announcement, "NIMH Career Enhancement Award to Advance Autism Services Research for Adults and Transition-Age Youth." The intent of the webinar is to provide an overview of the FOA and to address questions pertinent to preparing an application. Participation in the webinar, although encouraged, is optional and is not required for application submission. You must register to view this webinar via this link:

https://www.eventbrite.com/preview?eid=46610909485 . Once your registration is completed, you will receive a confirmation email with instructions for joining the session. Prospective applicants are encouraged to submit their questions or comments regarding the FOA to Nicole North (Nikki.North@nih.gov) at least 48 hours prior to the scheduled webinar. Please indicate "ASD Webinar" in the subject line of your email. The webinar link will be sent out to registered participants the day before, August 8th.

See Section VIII. Other Information for award authorities and regulations.

NIH grant policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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 not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and 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. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Candidates for this award must have a research or health-professional doctoral degree. This award is intended for well-established investigators who have records of independent, peer-reviewed Federal or private research grant funding.

Eligible candidates are independent investigators with currently funded independent research at any faculty rank or level, from the research assistant professor to the senior faculty level, who have shown clear evidence of productivity and research excellence in the field of their training, and who propose to expand their research capability, with the goal of making significant contributions to research on services for transition-age youth or adults with ASD. Candidates may be at the rank of Assistant, Associate or full Professor and will be required to have active, independent research grant support at the time of application. Investigators funded under this FOA will be expected to continue involvement in their ongoing research programs and propose to expand their research capability, with the goal of making significant contributions to research on services for transition-age youth or adults with ASD.

PD/PIs who have been awarded a NIMH grant or contract with one or more specific aims related to ASD services research for adults and/or transition-age youth are not eligible for this funding opportunity.

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, and each is from a different candidate.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

At the time of award, the candidate must have a "full-time" appointment at the academic institution. Candidates are required to commit a minimum of 6 person months to a maximum of 9 person months professional effort on the K18. Candidates are expected to engage in other duties as part of the remaining percentage of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-09-036 for more details.

This award is intended for independent investigators at all career stages, but it requires the commitment of an experienced mentor from the proposed new discipline. The mentor should be recognized as an accomplished investigator in the proposed research training area. It is not a requirement that the proposed mentor receive his/her primary research funding from the NIH. The mentor should have evidence of successfully mentoring faculty and productive collaborations, and be committed both to the career enhancement of the candidate and to the direct supervision of the candidate's research. The mentor and/or candidate must document the availability of sufficient research support to conduct the proposed research, in excess of the research development funds provided through this award. Candidates may identify more than one mentor, i.e., a co-mentor or mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career enhancement program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate's research. The candidate must work with the mentor(s) in preparing the application.

The candidate must have independent, peer-reviewed research support from a Federal or non-Federal funder as PD/PI at the time of submitting the application. Training (T and D43), research education (R25, R90), fellowship (F32, F33), clinical trial or research project planning (R34), Pathways to Independence (K99/R00), or other career development (K) awards are not considered eligible research support for this FOA. It is not a requirement that the candidate receive his/her primary research funding from the NIH.

Institutional Environment

The applicant institution must have a strong, well-established record of research and career development activities, and at least one faculty member qualified to serve as a mentor in areas related or complementary to services for adults or transition-age youth with ASD.

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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 activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Email: nimhpeerreview@mail.nih.gov

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

Candidate

Research Plan

Other Candidate Information

Mentor, Co-Mentor, Consultant, Collaborators

Environment & Institutional Commitment to the Candidate

Other Research Plan Sections

Appendix

All instructions in the SF424 (R&R) Application Guide must be followed. with the following additional instructions:

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Candidate Information and Goals for Career Development

Candidate's Background

• Describe the candidate's commitment to a career as a research scientist in the area of autism services for adults or transition-age youth.
• Describe the candidate's research efforts and accomplishments to date as an independent investigator, including publications, prior research interests and involvement, and history of research support; and describe how these prior research experiences are complementary to and inform the proposed program in research on services for adults or transition-age youth with ASD.
• Present evidence of the candidate's potential to augment his/her research career and to ultimately advance scientific progress in research on services for adults or transition-age youth with ASD through this career enhancement plan.
• Present evidence of the candidate's ability to interact and collaborate with other scientists, particularly those from other disciplines.
• Describe the candidate's prior clinical trials training and clinical trials research efforts, prior research interests and clinical trials experience. Where candidates have limited clinic trials experience, the plan to build expertise in this area should be well-described.

Career Goals and Objectives

• Describe the candidate's career goals and objectives of this career enhancement program.
• Describe the candidate's research career trajectory to date and explain how it relates to the proposed research career development enhancement program.
• Justify the need for further career enhancement in order to achieve the candidate's future research goals.
• Demonstrate how the proposed career enhancement program and the research, educational and mentoring resources of the sponsoring laboratory and institution will further the stated research career goals.
• The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

Candidate's Plan for Career Development/Training Activities During Award Period

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. The candidate and mentor may propose a mentoring team (and/or an advisory committee).
• Describe the career development plan, tailoring it to the candidate's goals, prior experience and career level, as well as to the goal of this FOA.
• Provide a systematic plan for progression of career enhancement and research experiences for the period of the award and beyond, including a timeline for the phasing of the career enhancement and research activities.
• Explain how the career development plan will enhance the candidate's independent research career trajectory into autism services research for transition-age youth or adults, including a description of any cutting-edge research skills and conceptual knowledge that will be acquired during the career award period.
• Describe any clinical, administrative, teaching, mentoring or grant-related research commitments the applicant will maintain during the period of the award, and the arrangements to be made with the applicant institution and/or the host institution to ensure the requisite protected time for this award period.
• Describe how the candidate will continue to oversee their extant research activities while conducting the career enhancement award research.

Research Plan Section

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy

• The structure and budgetary constraints associated with this career enhancement award will limit the scope of the research that can be achieved. Applicants will need to address the feasibility of completing their project within these constraints.
• A sound research project that is consistent with the candidate's level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate the quality of the candidate's research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
• The application must also describe the relationship between the mentor's research and the candidate's proposed research plan.
• If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.
• Although it is not expected that the description of the research would be as detailed as an application for an investigator-initiated research grant (e.g., R01), enough information should be provided to permit an evaluation of the scientific merit of the candidate's research activities and mentored research training.
• The mentor and/or candidate must document the availability of sufficient research support to conduct the proposed research, in excess of the research development funds provided through this award.
• Consistent with NIMH's experimental therapeutics approach (http://www.nimh.nih.gov/about/director/2012/experimental-medicine.shtml), the research plan should explicitly address whether an intervention engages the mechanism(s) presumed to underlie the intervention effects (the mechanism that accounts for changes in clinical/functional outcomes, changes in patient or provider behavior, etc.). Include the following: (1) a conceptual framework that clearly identifies the target(s)/mechanism(s) of the intervention being tested and the empirical evidence linking the target(s)/mechanism(s) to the clinical symptoms, functional deficits, or patient-, provider- or system-level behaviors/processes that the intervention seeks to improve; (2) plans for assessing engagement of the target(s)/mechanism(s) using valid measures that are as direct and objective as is feasible in the effectiveness context, including the specific measures, the assessment schedule, and the justification for the assessment strategy (e.g., evidence regarding the validity and feasibility of the proposed measures in the effectiveness context); and (3) analytic strategies that will be used to examine whether the intervention engages the target(s) and to conduct a preliminary examination of whether intervention-induced changes in the target(s) are associated with clinical benefit, as appropriate in a pilot trial.
• Appropriately-scaled studies might test whether a novel intervention engages and alters the hypothesized mechanism of action or proximal target; or pilot a novel intervention, where there is already evidence of target engagement, for an evaluation of feasibility and acceptability of the intervention in a patient population, as well as an evaluation of the relationship between change in the targeted mechanism and change in functional or clinical status, for example.
• For research projects that involve supplemental data collection to on-going studies, address the following: current status of the parent study, including enrollment, to date; the anticipated number of data points that can be captured with the proposed ancillary assessments; and the plan for and potential utility of additional analyses using the new data that will be collected (e.g., utility for piloting data collection procedures, for generating hypotheses, or for informing larger scale, more definitive studies that will be pursued in the future).
• Applicants proposing a clinical trial, ancillary or feasibility study should describe the planned analyses and statistical approach and how the expected analytical approach is suited to the available resources, proposed study design, scope of the project, and methods used to assign trial participants and deliver interventions.
• If proposing a feasibility study, to begin to address a clinical question, provide justification why this is warranted and how it will contribute to the overall goals of the research project including planning and preliminary data for future, larger scale clinical trials.
• Describe the proposed timelines for the proposed clinical trial, feasibility or ancillary study, including any potential challenges and solutions (e.g., enrollment shortfalls or inability to attribute causal inference to the results of an intervention when performing a small feasibility study).
• Describe how the proposed clinical trial or ancillary study will test the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy (This would not apply to a feasibility study).

Training in the Responsible Conduct of Research

• All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Plans and Statements of Mentor and Co-mentor(s)

• The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
• The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators.
• Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
• The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate's research, publications, and progression towards independence in ASD services research for adults or transition-age youth during the award period.
• Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
• The mentor must agree to provide annual evaluations of the candidate's progress as required in the annual progress report.
• The mentor or mentoring team must provide evidence of expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary or feasibility study and help him/her to meet timelines.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants do not need to provide their biographical sketches unless also listed as senior/key personnel. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.
• Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches.

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Description of Institutional Environment

• The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
• Describe the sponsoring institution's scientific environment and how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
• Describe the resources and facilities that will be available to the candidate, including any clinical trial-related resources, such as specialized administrative, data coordinating, enrollment, and laboratory/testing support. If applicable, include a description of the resources and facilities available at international sites.

Institutional Commitment to the Candidate's Research Career Development

• The sponsoring institution must provide a statement of commitment to the candidate's continuing development as a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
• If the candidate will train primarily at an institution other than the home institution, the home institution must provide assurances that the candidate will be relieved of responsibilities at the home institution as needed, so that the candidate will be able to commit the requested level of effort to this career enhancement award.
• Provide assurances that the candidate will be able to devote the required effort to activities under this award.The remaining effort should be devoted to activities related to the development of the candidate's career as an independent scientist.
• Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
• Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.

Appendix

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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 submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Important Update: See NOT-OD-18-229 for updated review language for due dates on or after January 25, 2019.

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.

In addition, for applications involving clinical trials:

The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through K awards may be sufficient to support only small feasibility studies.

Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate's potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

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.

Candidate

• Has the candidate provided evidence of excellence as an independent principal investigator (PI), including a record of research support and high-quality and/or impactful peer-reviewed publications?
• Are the prior research experiences complementary to the proposed program in ASD services research for transition-age youth or adults?
• Does the candidate show evidence of a high level of commitment to acquiring competencies necessary to conduct research relevant to services for adults and transition-age youth with Autism Spectrum Disorders?
• Does the candidate have high potential for successfully augmenting his/her research career capabilities and becoming an outstanding contributor to the research field relevant to the proposed research enhancement experience?
• Is there evidence that the candidate has the ability to interact and collaborate with other scientists, particularly those from other disciplines?
• Is the plan realistic and feasible?
• Is there evidence of the need for further career enhancement to achieve the candidate's research goals in services for transition-age youth or adults with ASD?
• Does the candidate have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
• Does the candidate have training (or plans to receive training) in data management and statistics including those relevant to clinical trials?

Career Development Plan/Career Goals and Objectives

• Is the career development plan appropriate in its content, scope, duration, and phasing for the candidate's stated career development goals?
• Is there a high likelihood that the proposed program will contribute substantially to the research career enhancement of the candidate?
• Is an appropriate level of the candidate's professional effort to the career development plan documented in the application?
• Are the candidate's career goals and objectives well-aligned with the proposed research career development enhancement program?
• Is the career development plan well-tailored to the candidate's goals, prior experience and career level?
• Is there a systematic plan for progression of career enhancement and research experiences for the period of the award, including a timeline for the phasing of the career enhancement and research activities?
• Is there a evidence that the career development plan will expand the candidate's independent research career into autism services research for transition-age youth or adults?
• Is there evidence that the candidate will acquire state-of-the art research skills and conceptual knowledge during the career award period?
• Is the plan realistic and feasible?
• Is there a description about how the candidate will balance the time and effort needed to meet the goals of the career enhancement award and continue to oversee his or her extant research activities?

Research Plan

• Is the study design justified and relevant to the clinical and statistical hypothesis being tested? Are planned analyses and statistical approaches appropriate for the proposed study design and methods used to assign participants and deliver interventions?
• Is the trial feasible within the duration, structure, budgetary constraints associated with this career enhancement award?
• Has the mentor and/or candidate demonstrated the availability of sufficient research support to conduct the proposed research, in excess of the research development funds provided through this award?
• Is the research plan consistent with the candidate's level of research development and the objectives of his/her career development plan?
• Is enough information about the plan provided to permit an evaluation of the scientific merit of the candidate's research activities and mentored research training?
• Is the study consistent with NIMH's experimental therapeutics approach?
• Does the study include (1) a conceptual framework that clearly identifies the target(s)/mechanism(s) and the empirical evidence linking the target(s)/mechanism(s) to behaviors or processes that the intervention seeks to improve; (2) plans for assessing engagement of the target(s)/mechanism(s) using valid measures that are as direct and objective as is feasible, including the specific measures, the assessment schedule, and the justification for the assessment strategy; and (3) analytic strategies that will be used to examine whether the intervention engages the target(s) and to conduct a preliminary examination of whether intervention-induced changes in the target(s) are associated with clinical benefit, as appropriate in a pilot trial?
• Does the application describe the relationship between the mentor's research and the candidate's proposed research plan?
• If proposing an ancillary study to an ongoing clinical trial, is a description provided of its relationship to and distinction from the larger clinical trial?
• If a feasibility study is proposed, is justification provided on why this is warranted and how it will contribute the overall goals of the research project including planning and preliminary data for future, larger scale clinical trials?
• Does the proposed clinical trial or ancillary study that will test the safety, efficacy or effectiveness of an intervention have the potential, at a later stage of the research, to lead to a change in clinical practice, community behaviors or health care policy?
• Are the plans to standardize, assure quality of, and monitor adherence to, the clinical protocol and data collection or distribution guidelines appropriate?
• Are the scientific rationale and need for a clinical trial, feasibility or ancillary study well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
• Is the clinical trial or ancillary study necessary for testing the safety, efficacy or effectiveness of an intervention, or in the case of a feasibility study necessary to establish feasibility of a future clinical trial?
• For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
• Is the trial feasible within the structure and budgetary constraints associated with this career enhancement award?
• Has the mentor and/or candidate demonstrated the availability of sufficient research support to conduct the proposed research, in excess of the research development funds provided through this award?
• Is the research plan consistent with the candidate's level of research development and the objectives of his/her career development plan?
• Is enough information about the plan provided to permit an evaluation of the scientific merit of the candidate's research activities and mentored research training?
• Is the study consistent with NIMH's experimental therapeutics approach?
• Does the study include (1) a conceptual framework that clearly identifies the target(s)/mechanism(s) and the empirical evidence linking the target(s)/mechanism(s) to behaviors or processes that the intervention seeks to improve; (2) plans for assessing engagement of the target(s)/mechanism(s) using valid measures that are as direct and objective as is feasible, including the specific measures, the assessment schedule, and the justification for the assessment strategy; and (3) analytic strategies that will be used to examine whether the intervention engages the target(s) and to conduct a preliminary examination of whether intervention-induced changes in the target(s) are associated with clinical benefit, as appropriate in a pilot trial?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

• Are the qualifications of the mentor(s) in the area of the proposed research appropriate?
• Does the mentor(s) adequately address the candidate's potential and his/her strengths and areas needing improvement?
• Is there adequate description of the quality and extent of the mentor's proposed role in providing guidance and advice to the candidate?
• Is the mentor's description of the elements of the research career development activities, including formal course work adequate?
• Is there evidence of the mentor's, consultant's, and/or collaborator's previous experience in fostering the development of independent investigators?
• Is there evidence of the mentor's current research productivity and peer-reviewed support?
• If co-mentors are proposed, are the mentors' respective areas of expertise and responsibility of each well-described?
• If a co-mentoring model is proposed, is there a clear description of how co-mentors will coordinate the mentoring of the candidate?
• If any co-mentor is not located at the sponsoring institution, is there a statement that adequately describes the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings?
• Are there adequate plans for monitoring and evaluating the career development awardee's progress toward independence in research on services for transition-age youth or adults with ASD?
• Does the mentor or mentoring team have the expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet timelines?
• Do statements from collaborators/consultants clearly describe their roles and document the appropriate expertise in the proposed areas of consulting/collaboration?

Environment & Institutional Commitment to the Candidate

• Is there clear commitment from the institution(s) to ensure that the candidate will devote the requisite effort directly to the research career enhancement activities described in the application?
• Is there strong institutional commitment to fostering the candidate's advanced research career development? Are there unique features of the scientific environment of the institution(s) that will benefit the proposed research and career development plan (e.g., useful collaborative arrangements, special equipment or analytic methods, unique subject populations)?
• Are the resources and facilities available to the candidate adequate for the proposed career enhancement experience?
• If the candidate will train primarily at an institution other than the home institution, has the home institution provided assurances that the candidate will be relieved of responsibilities at the home institution as needed, so that he or she will be able to commit the requested level of effort to this career enhancement award?
• Has the applicant institution provided assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan?
• Are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
• Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate?
• If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

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 score, but will not give separate scores for these items.

Milestones

Are appropriate, evaluative milestones clearly defined for the aims associated? Are the milestones feasible and quantifiable with regard to specific aims and timeline? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Not Applicable

Not Applicable

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 score.

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant's career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow's instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

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).

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) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group 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 score.
• Will receive a written critique.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications 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/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Specific to applications proposing clinical trials, ancillary or feasibility studies

Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA.

For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials, or a new ancillary study to an ongoing clinical trial. By law (Title VIII, Section 801 of Public Law 110-85), the lead investigator must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Milestones: Future support of a study funded under this FOA is contingent upon adequate participant recruitment based on projected milestones.

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. More specifically, for K Awards, visit the Research Career Development ("K") Awardees section of the NIH Grants Policy Statement.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor's Report must include an annual evaluation statement of the candidate's progress.

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Lauren D. Hill, Ph.D
National Institute of Mental Health (NIMH)
Telephone: 301-443-2638
Email: hillla@mail.nih.gov

Nick Gaiano, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: nick.gaiano@nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tamara.kees@nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 75.