NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the instructions in the Multi-Project Instructions for 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

Autism spectrum disorders (ASD) are complex neurodevelopmental disorders with early childhood onset. The prevalence of ASD may be increasing, and ASD is more common than previously thought. These disorders, for which there is presently no cure and only limited treatments, generally have lifelong effects.

The NIH historically has supported a vast array of projects in autism research. Beginning in 1997, the Collaborative Programs of Excellence in Autism (CPEA) focused on research related to the possible causes of autism, including genetic, immunological, and environmental factors. The CPEA program resulted from a congressionally mandated conference on the State of the Science in Autism. The attendees identified gaps in the understanding of autism and articulated directions for future research. Both NICHD and NIDCD sponsored the CPEA program. As a result of the efforts of researchers affiliated with the CPEA, data now exist on the genetics and phenotypic characteristics of the largest group of well-diagnosed persons with autism in the world. After the establishment of the CPEA Centers program, Congress enacted the Children's Health Act of 2000. This legislation mandated the establishment of a new autism research program. In response, the five Institutes of the NIH Autism Coordinating Committee (NIH-ACC; represented by NICHD, NIDCD, NIEHS, NIMH, and NINDS) implemented the STAART (Studies to Advance Autism Research and Treatment) program in 2002. Each of the eight STAART centers contributed to the autism research base in the areas of causes, diagnosis, early detection, prevention, and treatment. In 2007, consolidation of funding from the CPEA and STAART programs resulted in autism centers and networks called the Autism Centers of Excellence or ACE program. In FY 2007 and 2008, five centers and six networks were funded. In 2012 and 2013, three centers and eight networks were funded.

In response to the urgent public health significance of ASD, Congress passed the Combating Autism Act (CAA) of 2006. Through this Act, Congress intended to accelerate the pace, and improve the coordination of scientific discovery in ASD research. With the Autism Collaboration, Accountability, Research, Education and Support, or Autism CARES Act of 2014, Congress authorized the continuation of important investments in research, prevalence monitoring and services for both children and adults on the autism spectrum. This FOA is intended to build on the research progress and momentum of the past decade by funding research on innovative interventions and services for individuals with ASD across the lifespan, as well as cutting-edge research on the neurobiological basis and phenotypic characteristics of ASD that might lead to the identification of novel intervention strategies.

NIH will consider centers as well as networks in response to the ACE initiative. This FOA invites applications for ACE Centers supported by the P50 mechanism. A companion FOA (RFA-HD-17-008) invites applications for ACE Networks supported by the R01 mechanism.

This FOA invites applications for ACE Centers. An ACE Center must support major multidisciplinary research programs, consisting of interdependent and interrelated research projects. Meaningful and committed interactions among the disciplines must be evident. Projects may share materials, results, data, patient populations, or methodologies. Results of one project may well affect the understanding and interpretation of data from another project and thereby influence the nature of the research performed in one or more of the other projects. In addition, each project must have goals and objectives that focus on the common unifying theme that integrates the projects.

The intent is to fund research that will address important gaps in ASD research and that takes advantage of cutting edge technologies and methods for understanding the developmental trajectories, underlying mechanisms, biological pathways or signatures in ASD, including syndromic or monogenetic disorders with ASD (as long as the research can lead to a better understanding of the broader ASDs).

An ACE Center must include at least one research project related to the identification and evaluation of interventions and/or services research.

Intervention Projects

• Studies to evaluate dose, safety, tolerability, or some preliminary indication of efficacy such as the effect on a biomarker.
• Innovative and newly developed intervention strategies to improve outcomes and quality of life throughout the lifespan across all levels of abilities.

Services Projects

• Studies to understand how specific types of services, organizational processes and structures, financing mechanisms and evolving technologies and policies affect access to and delivery of services to people with ASD.
• Studies on adults that include strategies that enable post-secondary education, supported employment, health care and community integration.

Priorities for other research projects include, but are not limited to:

• Identification of risk and protective factors (e.g., environmental chemicals and/or their interplay with other factors such as: genetics, immune or mitochondrial abnormalities, diet and nutrition, medications, viruses) and their associated developmental windows that contribute to the development of ASD.
• Identification of biological signatures for autism and their relevance to prediction of treatment response and outcomes.
• Research aimed at understanding the underlying mechanisms, biological pathways or signatures in syndromic or monogenetic disorders with autism is also encouraged as long as the research can lead to a better understanding of the broader ASDs.
• Projects focused on understudied populations (e.g. adults or youth transitioning to adulthood, females, individuals from racial and ethnic minorities, individuals with intellectual disabilities, individuals who are minimally verbal) and in those with comorbid conditions.

The minimal structural requirements of an ACE Center under this FOA are:

• Research Project(s) -- An ACE Center must have a minimum of three and maximum of five research projects that include at least one research project related to interventions and/or services research. Other projects may address one of the above priority areas. Such projects may also include pilot projects. Those applying for a Type 2 renewal of an ACE Center are encouraged to form new collaborations with investigators.
• Administrative Core -- An ACE Center must include an Administrative Core that promotes an environment of communication and collaboration between investigators. The Administrative Core will establish a Center Advisory Committee including external scientific and lay members. The Center Advisory Committee will provide input and perspective about the proposed ACE Center activities, design of research projects, and impact of research results. The Center Advisory Committee should meet approximately once a year virtually or in person, and brief reports of the proceedings of the meeting and recommendations of the Committee should be included in the annual progress reports of the ACE network.
• Dissemination and Outreach -- An ACE Center must disseminate research knowledge and information and provide educational and awareness experiences to relevant audiences including students, families, and researchers who wish to pursue ASD research to enhance clinical research and practice. Examples of activities that would address this important aspect of the Center could include a designated grand rounds series on the Center's theme, collaborative case conference sessions, development of a website for the scientific and lay communities that includes tutorials and fact sheets, and development of laboratory-based learning experiences. Seminars and workshops designed for the scientific and lay communities are also appropriate. The ACE Centers are expected to play leadership roles in disseminating research findings to the community. Involvement of junior and established researchers who are new to the field of autism is encouraged. Recruitment of investigators from underrepresented racial and ethnic groups and disadvantaged backgrounds is also encouraged. Each ACE center must promote two-way communication between the investigators and the community of individuals with autism and caregivers. The purpose of the partnership is to lay the groundwork for successful recruitment and retention of study subjects. In addition, this partnership should inform investigators about patient concerns and feasibility of future studies in this population (such as risk/benefit determination, burden of visits and procedures, etc.) and inform the patient community about current research avenues and plans for future studies.

The minimal data collection requirements of an ACE Center under this FOA are:

All Center studies must include collection of data using the following forms or a justification of why the forms are not appropriate. These are widely accepted and NIH -established common data elements for autism research. Additional modifications to these forms may occur periodically.

• ACE Subject Medical History (https://ndar.nih.gov/ndar_data_dictionary.html?short_name=ace_subjmedhist01)
• ACE Family Medical History(https://ndar.nih.gov/ndar_data_dictionary.html?short_name=ace_fammedhist01)
• Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS-2), for use according to their published manuals
• Vineland Adaptive Behavior Scales, Second Edition
• An IQ or developmental assessment measure that includes both nonverbal and verbal components and results in standardized scores for both
• ACE Subject Physical Exam (where applicable to the purpose of a study) (https://ndar.nih.gov/ndar_data_dictionary.html?short_name=ace_physexam01)
• ACE Genomics Genetic Test (where applicable to the purpose of a study) (https://ndar.nih.gov/ndar_data_dictionary.html?short_name=gen_genetic_test01)

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

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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 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 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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Center Director:

The application must name one of the PD(s)/PI(s) as the overall Center Director. While Multiple PD/PIs are allowed, multiple Center Directors are not permitted.

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the 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).

A PD/PI may submit only one application, either an ACE Center or an ACE Network. This does not exclude multiple applications from a single institution, provided each application is submitted by a different PD/PI.

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the Multi-Project Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

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:

Maribeth Champoux, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-594-3163
Email: Maribeth.Champoux@nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Research Project	12
Administrative Core	6
Dissem Outreach Core: Use for Dissemination and Outreach Core	6
Other Core	6

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Research Projects: 3 required, 5 maximum; an ACE Center must include at least one research project related to interventions and/or services research.
• Administrative Core: required, 1 maximum
• Dissemination and Outreach Core: required, 1 maximum
• Other Core(s): Optional; 2 maximum

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Facilities and Other Resources: Provide adescription of space and physical resources for the Center.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: Provide a summary of the specific aims of the Center Overall.

Research Strategy: In the Research Strategy Section, provide an overview of the center including the following information.

Purpose of the Program - Discuss the overall P50 Center’s objectives and general plans for the proposed grant period.

Administrative Structure - Include information on the support and commitment of the parent institution for the program, the authority of the PD/PI. External advisory committees are permitted and applicants may describe the overall purpose. Describe the organizational framework and provide an organizational chart.

Research Program - Discuss the overall research program, highlighting its central theme. Describe the relationship between the Projects and Cores and their synergistic relationship to the central theme. Describe the impact that the proposed research will have on understanding the developmental, trajectory, pathophysiology, and broader understanding of ASD.

Description of Assurances and Collaborative Agreements - Provide an overview and rationale for any collaborative and cooperative endeavors or subcontracts. Letters of Assurance/Agreement for these arrangements are included below.

Summary of preliminary studies or progress - If this a renewal, include a detailed summary of progress to-date, scientific contributions to the field, and major research milestones achieved, including recruitment status.

Letters of Support: Provide Letters of Support/Assurance for the Center Overall. Letters of Support specific for individual components should be placed in those sections of the application.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Sharing Human Data via the National Database for Autism Research:
  
  In order to advance autism research as broadly and effectively as possible, investigators funded under this FOA who are collecting data from humans are expected to share those data among ASD researchers through a broadly accessible repository addressing the needs of the autism research community, e.g., via the National Database for Autism Research (NDAR; http://ndar.nih.gov). Fulfilling this expectation by the awardee will be among the terms and conditions of the award. Established by the NIH, NDAR, for example, is a secure bioinformatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDAR links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this FOA would be able to use these technologies to submit data to NDAR. To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDAR web site provides two tools to help investigators develop appropriate strategies: 1) the NDAR Data Sharing Checklist (http://ndar.nih.gov/ndarpublicweb/Documents/NDAR_Data-Sharing_Checklist_10152009.pdf) -- A list of critical steps in the data submission process, including informed consent language and GUID generation; and 2) the NDAR Data Submission Planning Cost and Effort Model (http://ndar.nih.gov/ndarpublicweb/Documents/NDAR_Data_Submission_Costs.xls) -- A customizable Excel worksheet that includes tasks and hours for the Principal Investigator and Data Manager. Investigators are expected to certify the quality of all data generated by grants funded under this FOA prior to submission to the repository and to review their data for accuracy after submission. Submission of descriptive data is expected semi-annually (every January 15 and July 15); submission of all other experimental data is expected after the primary objectives of the grant have been met (the primary objectives of a grant will be determined in consultation with the investigator’s Program Officer prior to award). For reference, the NDAR Data Sharing Policy (http://ndar.nih.gov/ndarpublicweb/policies.go) is available for review on the NDAR web site. NDAR staff will work with investigators to help them submit data types other than phenotypic, genetic, or imaging. For answers to frequently asked questions and how to contact the NDAR Manager, please see: http://ndar.nih.gov.
• Genetics and other Data Sharing in the ACE Program

The rapid dissemination of data and biomaterials is of increasing importance to the NIH for advancing research. The mission of the NIH and a goal of NIH policies are to promote discoveries to improve the health care and treatment of people, which is a mission that should be shared by the research community. The expedient sharing of data and biomaterials collected under scientific studies facilitates that mission. The NIH supports several databases through the NCBI, and the NIMH supports a repository for biospecimens of interest to mental health (http://nimhgenetics.org) to enable rapid sharing of data and biospecimens. These resources offer centralized sources of curated materials that are widely accessible to investigators in the international scientific community.

Investigators applying for awards under this FOA are encouraged to deposit data and biospecimens in NIH designated databases and appropriate repositories. However, depending on the nature of the data or biomaterials, there may not be an appropriate NIH supported resource for deposition. In such cases, alternative venues for data sharing can be considered. The sharing of data through NIH resources would not necessarily be exclusive and the data could be additionally shared through other investigator suggested venues.

It is expected that the investigator’s data sharing plan will specify the following elements: (1) description of what data will be collected including clinical data, diagnostic data, and physiological measurements such as MRI, (2) description of what biospecimens will be collected, (3) description of the data that will be derived from the biospecimens such as genotyping, sequence, metabolomic measures, proteomic measures, etc., (4) what data and/or biospecimens will be made available for deposit in databases or in a repository accessible to the research community, (5) a timetable for deposition of the data and/or biomaterials, and a specified time interval after which those data and materials can be released to the research community.

Guidelines have evolved from extensive discussion within NIH Program staff, consultations with human genetics researchers and advocacy members, recommendations from the Genetics Workgroup of the National Advisory Mental Health Council (NAMHC), and requirements of the National Database for Autism Research recommending shortened timelines for data deposition and reduced proprietary periods before the data is released to the research community. The deposition of data is encouraged to occur at intervals throughout the period of the award and not be detained until the end of the award period. Similarly, the proprietary period for data release is encouraged to be short to facilitate rapid data release. Adherence to shortened time intervals for data deposition and release is highly desirable. This is expected to result in all data being released to the scientific community no later than the end of the award period, even if a competing renewal application is submitted. More rapid sharing is strongly encouraged. Requests for exemptions or extensions will require compelling justification and will be fully evaluated through peer review and by program staff.

In consultation with NIH’s Office of the General Counsel, the National Human Genome Research Institute's Ethical, Legal, and Social Implications Research Program and the Department of Health and Human Services' Office for Human Research Protections, a model consent form has been developed for use in human genetic research at: https://www.nimhgenetics.org/documents/NIMH%20Human%20Genetics%20Initiative%20Consent.pdf. This model consent may serve as a template that is subject to modification and/or approval by local institutional review boards. It is expected that the applicant’s approved consent form addresses the following:

-Disclosure that any applicable biomaterials (DNA and cell lines), clinical data, and genotyping information will be stored at a central data management/ laboratory facility as part of an international resource of data and biomaterials distributed for the genetic analysis of autism and related disorders;

-Assurance that such data will be provided to a central facility without personal identifiers;

-Disclosure that analyses of these data will be conducted by other scientists currently not included within the current research team; and

-Disclosure that there is no plan to provide subjects with any financial benefits from commercial products derived from the data.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

When preparing your application in ASSIST, use Component Type Research Project.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Project Leads must commit a total minimum effort of 1.8 person-months per year to each Project. Multiple Project Leads are allowed for individual Projects. If there are multiple Project Leads, their combined effort must total at least 1.8 person-months per year.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Provide a description of specific aims for the Research Project.

Research Strategy: Follow the instructions in the SF424 Application Guide. In addition, the Research Strategy section should address the following items.

• Describe the relationship of the Project to the overall theme of the Center and the interactions with other Research Projects.
• Describe the Research Project's use of Core services, including why the services are needed and the advantages and cost effectiveness of Core unit usage for the project.
• Describe the impact that the proposed research will have on understanding the developmental, trajectory, pathophysiology, and broader understanding of ASD.

Consortium/contractual Arrangements: Describe and justify any consortium/contractual arrangements involved with the Project.

Letters of Support: Include pertinent letters of assurance and collaboration for the Research Project. For off-site projects, justification should be provided for the project's location, and plans for interaction and cooperation with the other components of the program should be addressed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Research Project)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Administrative Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field. Multiple Core Leads are allowed for Cores.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

The application must name one of the PD(s)/PI(s) as the overall Center Director. Multiple Center Directors are not permitted.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

The Center Director must commit a minimum effort of 2.4 person-months per year overall to the Center. This commitment could come from combined effort to the Center overall and from effort toward specific Projects or Cores.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Research Strategy: The Research Strategy section must provide a description of the following items.

• Purpose of the Core
• Organization of the Core and relationship to other components of the Center
• Staffing (Professional and Support)
• Services provided to other Core units and Research Projects
• The decision-making process for use of Core services and plans for cost-effectiveness and quality control.
• Management plan for the overall center, within-center data sharing, and proposed publication plan to be implemented across the center
• Advisory Committee - The Administrative Core must establish a Center Advisory Committee including external scientific and lay members. For new applications, describe the types of individuals who will be appointed to the committee, but specific individuals should not be named. For renewal applications, members of prior advisory committees should be named.

Letters of Support: Include any letters of support/assurance specific to this component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. This core is responsible for the Inclusion Enrollment Report that reflects total enrollment across all projects.

When preparing your application in ASSIST, use Component Type Dissem-Outreach Core

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

SF424 (R&R) Cover (Dissemination and Outreach Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Dissemination and Outreach Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Dissemination and Outreach Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Dissemination and Outreach Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Dissemination and Outreach Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field. Multiple Core Leads are allowed.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Dissemination and Outreach Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Dissemination and Outreach Core)

Specific Aims: Provide a description of specific aims for the Dissemination and Outreach Core.

Research Strategy: The Research Strategy section must provide a description of the following items.

• Purpose and objectives of the Core
• Organization
• Staffing (Professional and Support)
• Plans for translating and disseminating research-based findings to the broader scientific and practitioner communities; include detailed information about the intended audience, dissemination aims, and implementation plans to achieve these aims.
• Plans to promote two-way communication between the investigators and the community of individuals with autism and caregivers, ensure successful recruitment and retention of study participants, inform investigators about community concerns and feasibility of future studies in this population (such as risk/benefit determination, burden of visits and procedures, etc.) and share with the community current research avenues and plans for future studies.
• Plans for including graduate students, post-doctoral fellows, and/or early stage investigators in the scientific studies proposed in the application; the plan should at minimum include information about project staff who would be involved in coordinating the activities, and a description of research activities available to participants.
• Plans to involve junior and established researchers who are new to the field of ASD; plans to recruit investigators from underrepresented racial and ethnic groups and disadvantaged backgrounds.

Letters of Support: Include any letters of support/assurance specific to this component.

Resource Sharing Plan:

A Resource Sharing Plan is not needed for this Core.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Dissemination and Outreach Core)

Not Applicable

When preparing your application in ASSIST, use Component Type Other Core

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

SF424 (R&R) Cover (Other Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Other Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Other Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Other Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Other Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field. Multiple Core Leads are allowed.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Other Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Other Core)

Specific Aims: Describe specific aims for the Core.

Research Strategy: The Research Strategy section should provide a description of the following items:

• Objectives of the Core
• Administration of the core
• Staffing (Professional and Support)
• Services provide a description of the services to be provided by the core and the expected impact on productivity and quality
• Usage: Indicate past and/or current usage (e.g., assays performed, animals supplied, etc.) and list projects proposed for Core usage
• The decision-making process for use of Core services and plans for cost-effectiveness and quality control.

Letters of Support: Include any letters of support/assurance specific to this component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Other Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: https://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

For this particular announcement, please note the following:

Given the multi-component structure of the specialized P50 Center grants, special review criteria for the overall project will be considered as part of the overall scoring. These additional review criteria focus on the nature of the integration and synergy across research projects and cores. The overall score will also include the specific strengths of the individual projects and cores. Criteria for projects and cores are described in sections following criteria for the overall Center.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center 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 Center that by its nature is not innovative may be essential to advance a field.

Does the Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the Center 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? Will the ACE Center make an important contribution to the progress of autism research?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the proposed PD(s)/PI(s) have appropriate expertise to lead a multi-project center? Will new, junior faculty-level investigators be integrated within the structure of the ACE Center?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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? Will the environment of the ACE Center attract both established and junior investigators to autism research?

As applicable for the Center 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.

Center as an Integrated Effort Will there be coordination, interrelationships, cohesiveness, and synergy among the research projects and core components as they relate to the common theme of the center? Are the projects proposed multi-disciplinary in scope?

Are there clear advantages of conducting the proposed research as a center program rather than through separate research efforts? Will the research efforts taken together have more impact on the field than each separate project conducted in isolation? Will the research proposed in individual projects be enhanced by the center?

Are the mechanisms proposed for regular communication and coordination among investigators in the center? Are administrative structures in place for effective day-to-day management of the center, including arrangements for internal quality control of ongoing research?

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 Center 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.

Not Applicable

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable

As applicable for the Center 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.

Not Applicable

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 .

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.

Reviewers will provide an overall impact 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 Center 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? Is there a strong scientific premise for the project? 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? Will the proposed research advance the understanding of the developmental trajectory, pathophysiology, and broader understanding of ASD? Will the research project make an important contribution to the Center as a whole?

Investigator(s)

Are the Project Lead(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-Lead, 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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

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.

Vertebrate Animals

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.

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

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

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.

Applications from Foreign Organizations

Not Applicable

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) Genomic Data Sharing Plan.

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.

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.

Reviewers will assign an impact score based on the assessment of each Core independently in terms of the criteria below. Separate criterion scores will not be assigned for Cores.

All Cores

Are the qualifications, experience, and commitment of the core director and other core personnel appropriate? Will the quality of services provided enable center investigators to achieve their research goals? Is there cost effectiveness in the core; will there be quality control measures taken for core procedures? Is the proposed use of core services by the budgeted center projects appropriate?

Administrative Core

In addition to the above criteria, the Administrative Core will be evaluated on the following:

Is there an effective plan for selecting and utilizing an Advisory Committee? Does the Core Lead have experience in research administration? Is there a decision-making process within the proposed center for the evaluation of research productivity, for allocation of funds and for management of the resources? Is there an effective plan for center evaluation, including the use of any internal and external advisory groups?

Dissemination and Outreach Core

In addition to the above criteria, this core will be evaluated on the following:

Does the applicant describe an effective plan for Dissemination and Outreach activities? Is there a well-articulated plan for involvement of pre-doctoral, post-doctoral, and/or early career investigators in research projects and/or cores of the Center?

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by convened by the Center for Scientific Review, 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 of initial peer review will not be accepted for applications submitted in response to this FOA.

All new applications will initially be assigned to NICHD; renewal applications will be assigned to the institute that previously supported the project.

. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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.

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.

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.

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.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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.

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.

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.

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: https://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

Alice Kau, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: 301-496-1385
Email: kaua@mail.nih.gov

Judith Cooper, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: 301-496-5061
Email: Cooperj@nidcd.nih.gov

Cindy Lawler, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-316-4671
Email: lawler@niehs.nih.gov

Lisa Gilotty, PhD
National Institute of Mental Health (NIMH)
Phone: 301-443-3825
Email: gilottyl@mail.nih.gov

Laura A. Mamounas, PhD
National Institute of Neurological Disorders & Stroke (NINDS)
Phone: (301) 496-5745
Email: mamounas@ninds.nih.gov

Maribeth Champoux, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-594-3163
Email: Maribeth.Champoux@nih.gov

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-0909
Email: myersc@nidcd.nih.gov

Lisa Archer Edwards, M.B.A.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0751
Email: archer@niehs.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov

Jeannette Gordon
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-3813
Email: jgordon@mail.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.