It is critical that applicants follow the Multi-Project (M) 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

Purpose

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through research, paving the way for prevention, recovery, and cure. Mental disorders affect approximately 15-20 percent of the U.S. population annually. These disorders include schizophrenia, bipolar disorder, anxiety, depression, autism spectrum disorders, obsessive compulsive disorder, post-traumatic stress disorder, attention deficit disorder, and eating disorders - many of which begin early in life and are conceptualized as developmental in origin. Tremendous strides have been made in recent years towards understanding the microenvironment (genetic and epigenetic variation, molecules, and signaling pathways), brain systems (cells, circuits, and networks) and environmental factors involved in cognitive and affective processes as well as the underlying mechanisms that may be disrupted in mental disorders. While exciting advances continue within specific disciplines, there is a growing need for collaborative research programs at the level of basic neuroscience or at translational levels that extend across traditional disciplinary boundaries.

This Funding Opportunity Announcement (FOA) encourages applications for Conte Centers for Basic Neuroscience or Translational Mental Health Research. The purpose of these Centers is to support interdisciplinary teams of researchers engaged in novel, creative, and integrated experimental approaches to address high-risk, high-impact scientific questions that will significantly advance the state of the science in brain and behavioral research to ultimately provide the foundation for understanding mental disorders and/or transform the understanding and treatment of mental illnesses. Conte Centers exemplify a collaborative, cutting-edge, interdisciplinary research program conducted at multiple levels of analysis that may include genes, cells, synapses, circuits, behavior and/or disease states, in model systems or humans, and from the prenatal period throughout the lifespan. It is also expected that Conte Centers will develop data and other research resources and make them widely available to the scientific community.

Successful centers address a well-defined and unified scientific hypothesis or problem. Center projects may address any aspect of basic neuroscience or genomic approaches supported by NIMH. Center projects may also include translational integration of neuroscience to address clinical questions in humans to identify the etiology, pathophysiology, developmental trajectory, potential biomarkers and/or the mechanistic substrates of interventions with the goal of eventual prevention, treatment, and cure of mental disorders across the lifespan. Discovery-based as well as technology development components in support of the primary scientific question are welcomed. The Conte Center program is intended to support research that demonstrates an extraordinary level of synergy, integration, and potential impact on our understanding of basic brain mechanisms and/or the pathophysiology, progression, and treatment of mental disorders. The program is intended only for projects that could not be achieved using other research project grant mechanisms. Support through the Center program is provided both for individual research projects and for cores that are critical for the integration across Center components. Centers must be conceptualized within an interdisciplinary framework, incorporate well-integrated programs of cutting-edge research, and provide plans for rapid, widespread sharing of the resulting data, methods, and resources to the community. A strong vision of how the Center will advance the field beyond the goals of the individual projects is essential for successful applications. The Conte Centers program also provides an opportunity to establish interdisciplinary basic neuroscience or translational research experiences for students and postdoctoral fellows.

Scope of Research

The primary purpose of each Conte Center is to support a multidisciplinary team of leading basic neuroscience, translational neuroscience, and/or clinical neuroscience researchers engaged in a highly integrated and focused program directed at a well-defined and unified scientific question (hypothesis) or problem. The institute seeks both basic neuroscience Conte Centers as well as translational Conte Centers. A Conte Center need not include both basic neuroscience and translational research foci. The Conte Centers program continues to seek highly meritorious applications across the full spectrum of basic and translational research supported by the NIMH. Conte Centers should comprise a collaborative, cutting-edge, multidisciplinary research program conducted at multiple levels of analysis that would be difficult to undertake within the confines of a single laboratory or a small-scale collaboration.

The NIMH Strategic Plan was developed to inspire and support research that takes advantage of these recent technological advances and opportunities, and to bring into sharper focus questions and perspectives that will transform the diagnosis, treatment, and prevention of mental disorders. NIMH also encourages projects that address the fundamental mechanisms that cut across current diagnostic categories as outlined in the Research Domain Criteria (RDoC) project.

Potential applicants are also encouraged to consult the report of the National Advisory Mental Health Council (NAMHC) Genomics Workgroup, which makes recommendations for areas of opportunity in genomics research to understand the genetic etiology of mental health disorders. Applicants should also consult NOT-MH-18-058 Notice of Information: NIMH’s Interest in Areas of Stress Biology Research which clarifies NIMH’s interest in the most rigorous approaches to understanding the impact of stressors on brain and behavior.

The Conte Centers program provides a mechanism for maximizing the potential for scientific synthesis and discovery across levels of analyses from genes and molecular signaling through systems level integration and behavior in humans and model systems across the lifespan. Thus, the Conte Centers program provides a unique opportunity to address one or more of the strategies and priorities outlined in the NIMH Strategic Plan and the related NAMHC reports.

Some general characteristics of Conte Centers are listed below:

• Conte Center applications should be driven by the timeliness and richness of opportunities. They should integrate research projects across levels of scientific analysis. These levels of analysis can be tightly focused; for example, Centers that propose a series of basic science projects using different model systems, approaches and methods, exploring different facets of related fundamental knowledge would be appropriate. Centers can also extend across a much wider range in levels of inquiry and span genetics, basic neuroscience, basic behavior and/or translational topics. Potential applicants are strongly encouraged to discuss their research concept and approach with the appropriate NIMH contact before developing their applications to ascertain that their concept is well aligned with NIMH interests and priorities and the goals of the Conte Centers program [see section VII Agency Contacts].
• Conte Centers are encouraged to include exploratory, discovery focused, or high-risk projects that add value to the Center and increase the potential for fundamental new discoveries toward understanding brain mechanisms directing the development and expression of behaviors including pathophysiology across the lifespan.
• Exploratory projects using patient populations to test biomarkers or interventions developed/identified elsewhere within the Conte Center may be included in a Conte Center application only if they fully conform with NIMH policies for clinical trials (see: http://www.nimh.nih.gov/funding/clinical-trials-for-researchers/index.shtml).
• Conte Centers may include technology development as an element, but not as the primary focus of the Center. When technology development is an integral part of the scientific goals, it should be proposed as a project. When technology development is part of a standard service provided to support Center projects, it should be proposed as a Research Support Core.
• Conte Centers should include three or more research projects and an administrative core. Additional core(s) to provide research support functions, including animal, analytical, data management, diagnostic, recruitment, informatics, etc. are optional.
• Centers may comprise projects and cores at a single institution or at multiple institutions. Collaborations between laboratories using state-of-the-art, scientifically rigorous methods are encouraged, even if this means that the investigators are geographically distributed. Plans for the synergistic integration of projects and cores within a Center, whether at a single institution or geographically distributed, should be well developed.

In addition to considering the strengths and weaknesses of the scientific premise that form the basis for the questions asked, the application should be constructed to enhance reproducibility through scientific rigor, consideration of sex and other relevant biological variables, and incorporation of authentication of key biological and/or chemical resources (see: http://grants.nih.gov/reproducibility/index.htm).

Applicants are strongly encouraged to consult appropriate NIMH Scientific/Research staff, starting with the conceptualization process, to ascertain a good alignment of their planned Center goals with program priorities [see section VII Agency Contacts].

The NIMH has interest in well-balanced Conte Centers that incorporate contributions from a diverse pool of highly qualified investigators.

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.

Student and Postdoctoral Research Experiences

It is expected that research opportunities and experiences for students and postdoctoral fellows supported by a Conte Center will be closely coordinated with existing formal research training programs at the participating institution(s). As part of the Administrative Core, the Conte Center should provide opportunities for individuals to become engaged in the innovative interdisciplinary collaborative interactions driving the Center's research objectives and to obtain a broad, multidisciplinary perspective in the Conte Center research area.

Communication and Outreach

As part of the Administrative Core, Conte Centers are encouraged to include a communications element that includes a website and public outreach and dissemination activities. Encouraged outreach activities may include Conte Center-focused partnerships with local school systems, science museums or related institutions. These activities may involve participation of Conte Center investigators in special lectures or laboratory demonstrations as part of ongoing outreach programs, such as Brain Awareness Week, National DNA Day, and the NIMH Outreach Partnership Program (http://www.nimh.nih.gov/outreach/partnership-program/index.shtml). Visits from classroom groups would also be appropriate to include as an outreach activity.

Website

Conte Centers are encouraged to develop and maintain a website targeted to a broad audience that describes the Conte Center and the implications of research supported by the Center towards advancing our understanding of the biology of mental disorders.

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 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)
• Eligible Agencies of the Federal Government
• 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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.

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).

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST 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.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, 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.

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: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core (use for Administrative Core)	6 pages
Project	6 pages
Research Core (use for Research Support Core)	6 pages

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
• Administrative Core: Required, maximum of 1
• Projects: Required, minimum of 3
• Research Support Core: Optional, maximum of 3

When preparing your application, 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.

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.

Center Director (PD/PI) must have a demonstrated capability to organize, administer, and direct the Center. A Center Director must demonstrate leadership in the area of science proposed, have a strong record of high impact scientific achievements, and head at least one of the research projects and the administrative core.

Each proposed Center Director must commit a minimum of 3 person months per year overall to the Center and be a leader on one of the projects and of the administrative core. The 3 person months should be a total of the Center Director's efforts on his/her project(s) and core(s).

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.

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims: Provide a concise description of the overall Center aims. Outline how the projects and core(s) will contribute to attaining the Center objectives.

Research Strategy: The Research Strategy should begin with a brief overview of the center describing the scientific problems being addressed, the integration of the Center components, and why these components are essential for accomplishing the goals of the overall Center. The overview should be targeted to a broad audience and be concise. The overview should include:

1. Goals, relevant background and significance and a description of the impact of the science proposed in relation to the state-of-the-art of the field. This section should also include an explanation of how the work proposed is innovative.

2. Value added by an interdisciplinary Centers approach. This section should address why the proposed research justifies a Center and should include a description of the contribution of each of the projects and cores in achieving the Center’s major objectives, a description of how the Center as a whole will benefit from interdisciplinary interactions, an explanation of why this work cannot be accomplished by a cluster of R01s, and why the whole is significantly better than the sum of its parts.

3. For the basic neuroscience centers, an explanation of the timeliness and the potential importance and relevance of the proposed research to advancing our understanding of the fundamental mechanisms of brain development, function, gene regulation, or behavior; or preclinical approaches to treatment development, or computational approaches to understanding these mechanisms. For the translational centers, an explanation of how the proposed work integrates component projects (basic, preclinical or clinical) with translational concepts to advance our understanding of disease etiology and/or treatment of mental health disorders. Disorders of interest to NIMH include depression, bipolar disorder, post-traumatic stress disorder, anxiety, schizophrenia, obsessive compulsive disorder, autism spectrum disorders, and other developmental disorders. NIMH is particularly interested in understanding fundamental brain changes that occur during sensitive periods of brain development and periods of increased vulnerability to psychopathology.

4. If a scientific project or core involves risk, applicants should explain how the degree of risk will be counterbalanced by the benefits to be gained and how these benefits will impact the science in relation to the state-of-the-art of the field. Applicants should also explain potential threats (if any) to data integrity and how these threats might affect the feasibility of the proposed research.

5. In this section applicants should address the strengths and weaknesses of the scientific premise forming the basis of their questions, enhancing reproducibility through rigor, sex and other relevant biological variables, and the authentication of key biological and/or chemical resources (see: http://grants.nih.gov/reproducibility/index.htm).

The Research Strategy should also include:

1. Preliminary Data: This section should include evidence for feasibility and preliminary findings and/or progress made during the previous funding period. This section should also present very clear evidence that the research team has been/will be able to work together effectively to accomplish the research proposed in the projects.

2. Center Approach: This section should describe the working scientific and logistical design, as well as the resource support necessary to implement the research, demonstrating how the Center mechanism will serve to enhance the individual projects proposed. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included. Institutional support, if any, should be described in this section.

3. Timeline, Milestones, Evaluation Plan and Advisory Board: A graphic Overall Center Timeline and a descriptive Milestones section for the overall Center must be included in the Research Strategy section for the Overall Center. Milestones should be identified along the timeline. Milestones should be well described, quantifiable, and scientifically justified benchmarks at critical junctures as well as annual indicators of progress. This section should also include specific proof-of-concept test(s) along with any alternative strategies should any component efforts fail to perform as expected. This Overall Center Timeline is separate from the Study Timeline in section 2.7 of the PHS Human Subjects and Clinical Trials Form. The Overall Center Timeline should include the establishment of a to-be-named advisory board to be convened annually to assess progress and accomplishments, and to advise the Center. It is very important that potential advisory board members not be contacted or identified in advance (in the application) to minimize conflicts during the application review process and so that all individuals with appropriate scientific expertise remain eligible for consideration by NIMH review staff for the peer review panel that evaluates Conte Center applications. For new Conte Center applications, advisory board members should only be identified and convened after an application is funded. For renewal applications, the names of individuals who served as advisory board members during the previous 5 years should be listed. During the project period, the Center Director will be expected to refer to these milestones in annual progress reports.

Letters of Support: Include letters of support relevant to the overall center here. Letters detailing contributions to individual components should be placed in their respective individual Project or Core component. When multiple institutional sites are involved, a letter of support should be included that details the description of the cooperative administrative arrangements.

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, must address a Data Sharing Plan.

Appendix:

Only 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.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be 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 within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed with the following modification: Delayed Onset studies are not permitted for Conte Centers.

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

When preparing your application, use Component Type Admin Core.

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 Administrative Core 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.

Each proposed Center Director must commit a minimum effort of 3 person months per year overall to the Center and be a leader of one of the projects and of the administrative core. The 3 person months should be a total of the Center Director's efforts on his/her project(s) and core(s). The 3 person month requirement also applies to any individual listed as a PD/PI in a multiple PD/PI Center.

The Administrative Core Leader must commit a minimum effort of 1 person month per year to the core. If there are multiple leaders for the Administrative Core, the combined efforts of the identified Administrative Core Leaders must total 1 person month.

The Administrative core budget should include costs for:

• Data and resource sharing (personnel, materials, banking, analysis, and shipping costs)
• Investigator and advisory board travel
• Website
• Student and postdoctoral research experiences and outreach

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.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide a concise description of the goals of the Administrative Core.

Research Strategy: The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support multidisciplinary systems biology research, student and postdoctoral research infrastructure and outreach, to foster synergy, and to support planning and evaluation activities.

Highlight features of the Administrative Core that will enhance the collaborative effort, including optimizing communication, decision-making and sharing between the Project and/or Scientific Core teams.

Describe how each Project or Scientific Core (as applicable) will draw upon the Administrative Core and how it in turn will respond to Project or Research Support Core needs. The description of the Administrative Core should clearly indicate the facilities, resources, services and professional skills that the Core will provide. Moreover, information must be provided about how the collective operation of the Core will be achieved in a coherent manner.

Additional information is encouraged:

• Student and Postdoctoral Research Experiences: Plans for engaging students and postdoctorates in the interactive processes underlying the Conte Center program and objectives should be described here. This section should also describe how research experiences in the Conte Center will synergize with existing institutional training programs.
• Website: Plans for establishing and maintaining a Conte Center website targeted to a broad audience that describes the Conte Center and the implications of research supported by the Center for advancing our understanding of the biology of mental disorders should be described here. The website should also include information pertaining to the sharing of resources with the scientific community. This website is intended to be distributed to a variety of educated audiences with broad backgrounds and interests, such as the NIMH Outreach Partners (see: http://www.nimh.nih.gov/outreach/partnership-program/index.shtml). However, links to existing or draft Conte Center websites should not be included as these may pose a hazard to the anonymity of peer review.

Public Outreach/Dissemination Plan: Outreach and dissemination activities that will inform the public about Conte Center activities and enhance science literacy should be described in this section.

Letters of Support: Include letters of support relevant to the administrative core.

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:

Information on the sharing of all resources generated by Center activities should be consolidated and detailed in this section and include the following elements:

• Project management of resource sharing.
• Description of what specific resources will be shared (e.g., model organisms, reagents, tools, software, etc.)
• Schedule/timeline for availability of resources to other users.
• Persons who will have access to the resources (written as broadly as possible to the extent consistent with applicable laws, regulations, rules and policies).

Plan for post award disposition of resources.

Appendix:

Only 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 human subjects research, clinical research, and/or NIH-defined clinical trials 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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed with the following modification: Delayed Onset studies are not permitted for Conte Centers.

Project

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

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

SF424 (R&R) Cover (Project)

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 (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project)

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.

Application guide states that Project Narrative is required. However, it is only required for the Overall component.

Project /Performance Site Location(s) (Project)

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 (Project)

• 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.
• It is expected that each Research Project leader be at the forefront in the area of science proposed and have a successful record of bringing novel and significant projects to fruition as the principal investigator.
• The Center Director must be a leader of one of the projects

Budget (Project)

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

Leaders of a Project must commit a total minimum effort of 1.8 person months per year to each project. Multiple project leaders are allowed for Projects. If there are multiple leaders on a Project, the combined efforts of the identified project leaders must total 1.8 person months per year per Project.

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 (Project)

Introduction to Application: An Introduction is allowed for each component for resubmission applications.

Specific Aims: List the specific objectives of the proposed research.

Research Strategy:

Significance: Describe the overall goals and how the the science proposed in the project will advance the state-of-the-art of the field. This section should also explain the contribution of the project to the overall goals of the Center, how the project will interact with and benefit from other components of the Center and the appropriateness of the center approach and environment.

Innovation: Describe the unique and innovative contributions that will be made by this project. Explain how these contributions will synergize with the rest of the Center to achieve more than what could be achieved through an independent research project.

Approach: Describe the feasibility of the proposed experiments, the advantages of any new methodologies, the potential pitfalls, and alternative approaches for the project and how these might impact on progress in the overall Center.

Environment: Describe the scientific environment in the context of anticipated interactions between this project and other components of the Center and anticipated progress in the overall Center.

Letters of Support: Include letters of support relevant to the project.

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. All information on the sharing of resources should be consolidated in the Administrative Core.

Appendix: Only limited appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Investigator Brochure or Package Insert

The filename "Investigator Brochure or Package Insert.pdf" must be used for this attachment.

The Investigator Brochure or package insert may be attached for a clinical trial testing a drug or biologic.

PHS Human Subjects and Clinical Trials Information (Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Section 2 - Study Population Characteristics

2.7 Study Timeline

Applicants should include a section on Sample Subject Timeline. Address the time it will take for an individual participant to complete all study visits. When possible provide a brief snapshot of the protocol’s schedule of events capturing time points and planned activity at study visits. For example:

• Week 1 Screening/Baseline Visit (4 hours) - eligibility criteria, obtain informed consent, screening assessment(s), labs, etc.
• Week 2, 4, 6, 8, Study Visit(s) (3 hours) intervention(s), assessment(s), labs, scan(s) etc.;
• Week 12 and 18 Follow-up visits (3 hours) - assessment(s), labs, scan(s) etc.
• Week 24 End of study visit (2 hours) - assessment(s), labs, scan(s) etc.

Applicants should address Study Duration. Include the estimated time (in months) from when the study opens to enrollment until: (a) completion of data collection; and (b) final data analyses.

Applicants are required to provide detailed project performance and timeline objectives. This section must include an overview of the project timeline for the following general milestones, as applicable:

• Finalization of clinical protocol (with program agreement, if applicable)
• Registration of clinical trial in ClinicalTrials.gov
• Completion of regulatory approvals
• Enrollment of the first subject
• Enrollment and randomization, if applicable of 25%, 50%, 75% and 100% of the projected study population, including women, minorities across the full lifespan (as appropriate)
• Completion of data collection time period
• Completion of primary endpoint and secondary endpoint data analyses
• Completion of final study report
• Reporting of results in ClinicalTrials.gov.

These milestones will be negotiated at the time of the award, as appropriate.

Section 3 - Protection and Monitoring Plans

3.1 Protection of Human Subjects

The description of the study population should address demographic group, required health status, and geographic location.

Describe methods and systems to ensure data confidentiality and subject privacy.

3.3 Data and Safety Monitoring Plan

Describe the locations where the monitoring will occur (e.g., participating clinical sites, data center, clinical coordinating center) and what data will be reviewed.

Provide an overall description of the monitoring plan to ensure adherence to the protocol, and the quality and consistency of the study intervention(s), including fidelity monitoring for behavioral interventions. Include methods to monitor study intervention and system to record and manage exceptions and deviations. If applicable, describe monitoring of participating facilities such as labs or pharmacies for adequate handling and storage of investigational product(s) and study specimens. Include a description to assure that the investigational product(s) accountability and reconciliation are performed adequately during and at the end of the trial per applicable regulatory requirements.

Describe plans for handling any deficiencies that are uncovered and in cases of serious deficiencies the appropriate reporting to relevant authorities, including but not limited to the IRB of record, DSMB if one is assigned, FDA if applicable, institutional officials and the NIH.

Describe methods and systems for data collection (e.g., Case Report Forms/CRFs), data entry, data verification and data validation. Describe the data query process and frequencies and any planned mitigation strategies in the event of noncompliance.

Describe process for locking the final trial datasets and the planned procedures on data access and sharing, as appropriate.

Section 4 - Protocol Synopsis

4.1 Brief Summary

NIH recognizes the role of both effectiveness/pragmatic versus efficacy trials and understands that all elements will not apply to all trial types (e.g., frequent patient visits, 100% source data verification, frequent site monitoring) for example for large simple effectiveness trials. Applicants should ensure applicable elements are provided based on the type of trial planned (e.g., efficacy, effectiveness, randomized registry or pilot trials).

4.2 Study Design

4.2.c Interventions

If applicable provide a description of the dose frequency and type of administration of the intervention(s).

4.6 Will the study use an FDA-regulated intervention?

4.6.a If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status

If applicable, provide FDA info available on early feasibility studies.

Section 5 - Other Clinical Trial-related Attachments

5.1 Other Clinical Trial-related Attachments

The following additional Clinical Trial-related attachments are required for applications that include a clinical trial: "Common Data Elements Applicability" and "Clinical Protocol Schedule of Events."

Common Data Elements Applicability

Applicants are required to provide a description of their plans to consider applicability of Common Data Elements (CDEs). The filename "Common Data Elements Applicability.pdf" must be used for this attachment. If more than one set of CDEs are used, they should be combined in this attachment.

Investigators are encouraged to consult the Portal and to describe if NIH-supported CDEs will be used in the proposed clinical trial. If CDEs are not applicable, applicants are expected to explain why.

Applications that lack the 'Common Data Elements Applicability' attachment are considered incomplete and will not be peer reviewed.

Clinical Protocol Schedule of Events

The filename "Clinical Protocol Schedule of Events.pdf" must be used for this attachment. If more than one set of Clinical Protocol Schedules of Events are used, they should be combined in this attachment.

The clinical protocol schedule of events is to capture a snapshot of the time it takes for protocol procedures to be completed by an individual participant during the trial.

For example:

• Week 1 Screening/Baseline Visit (4 hours)- eligibility criteria, obtain informed consent, screening assessment(s), labs, etc.
• Week 2, 4, 6, 8, Study Visits (3 hours) intervention(s), assessment(s), labs, scan(s) etc.
• Week 12 and 18 Follow-up Visits (3 hours)- assessment(s), labs, scan(s) etc.
• Week 24 End of study visit (2 hours)- assessment(s), labs, scan(s) etc.

This document may be provided in a tabular format.

The following additional Clinical Trial-related attachment is optional for applications that include a clinical trial: " Material safety data sheet (MSDS)."

Material safety data sheet (MSDS)

The filename "Material safety data sheet (MSDS).pdf" must be used for this attachment. If more than one Material Safety data sheets are used, they should be combined in this attachment.

Labeling information or summary of safety information from prior studies may be attached for a clinical trial testing a significant risk investigational device for which an application for a new Investigational Device Exemption (IDE) will be submitted.

Delayed Onset Study

Delayed Onset studies are not permitted for Conte Centers.

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

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

SF424 (R&R) Cover (Research Support 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 (Research Support Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Support 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.

Facilities and Other Resources: The description of the Research Support Core should indicate how its facilities, resources, services, and professional skills will be leveraged to provide services to the proposed center.

Project /Performance Site Location(s) (Research Support 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 (Research Support 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.
• 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.
• It is expected that Research Support Core leaders demonstrate competence in the area of science proposed and have a record of interacting and working well with other investigators at their institution and elsewhere.

Budget (Research Support Core)

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

Leaders of Research Support Cores must commit a minimum effort of 1 person month per year to the Research Support Core. Multiple leaders are allowed for Research Support Cores. If there are multiple leaders, the efforts of the identified leaders must total 1 person month per year per core.

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 (Research Support Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide a concise description of the goals of the Research Support Core. Explain how the Research Support Core will contribute to attaining the Center objectives.

Research Strategy: A Research Support Core can be a laboratory, a facility, a service, or other shared resource that supports other Center components in their activities. Descriptions for the core should include a brief overview and a description of the services and resources to be provided to other Center components. This section should address how the core will contribute to the overall goals of the Center as well as which projects will be supported by the Research Support Core and the manner in which that support will be rendered by the core. Issues to be addressed include: quality control, procedures for selecting projects that use the Research Support Core, cost effectiveness, and increased efficiency. While scientific activities per se are not an essential part of a Research Support Core, quality assurance activities that evaluate its operations and are directed at problem identification and improvement of core functioning are appropriate.

Letters of Support: Include letters of support relevant to the Research Support Core.

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. All information about Resource Sharing Plans should be consolidated in the Administrative Core section of the application.

Appendix: Only limited appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Support Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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

Delayed Onset studies are not permitted for Conte Centers.

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: http://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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Use of Common Data Elements in NIH-funded Research

NIH encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g., genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

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.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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 the prior research that serves as the key support for the proposed project rigorous? 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?

Does a Basic Neuroscience Center application propose timely and compelling work for advancing our understanding of the fundamental mechanisms of brain development, function, gene regulation and/or behavior? Does a Translational Neuroscience Center application propose work that clearly integrates component projects (basic, preclinical or clinical) with translational concepts to advance our understanding of disease etiology and/or treatment of mental health disorders? Does the project cite prior relevant trials or systematic reviews that would help to justify why this trial is needed and inform its design?

In addition, for applications involving clinical trials:

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or those 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?

Has the proposed Center Director demonstrated capacity to organize, administer, and direct the Center? Does he/she have demonstrated leadership in the area of science proposed, and have a strong record of scientific achievements?

In addition, for applications involving clinical trials:

With regard to the proposed leadership for the Center, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating 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?

Does the application include an adequate explanation of how the work proposed is innovative? Does the application explain how the degree of risk will be counterbalanced by the benefits to be gained and how these benefits will impact the science in relation to the state-of-the-art of the field?

In addition, for applications involving clinical trials:

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Is an interdisciplinary Center approach necessary and suitable for the proposed work? Does the application adequately describe how the Center as a whole will benefit from interdisciplinary interactions, providing an explanation of why this work cannot be accomplished by a cluster of R01s, and why the whole is significantly better than the sum of its parts? Is there a clear, detailed plan for managing the Center's research and administration, fostering synergy, ensuring appropriate prioritization of research, needed course corrections and problem identification and resolution, that conveys a high likelihood of effective, productive management of the Center as a whole?

If there are potential threats to the data integrity of the proposed research, will these threats affect the feasibility of the proposed research?

Is the eligible population available?

In addition, for applications involving clinical trials:

Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)?

Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approaches appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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? If a Center is distributed across disparate sites, are there sufficient plans to facilitate communication and collaboration across the sites?

In addition, for applications involving clinical trials:

If proposed, 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 at the proposed site(s) or centers? Are the 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?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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 Components: Individual Center Components (Administrative Core, Projects, and Research Support Cores) will be assessed for relevant strengths and weaknesses in the context of the Overall Center but will not be given individual scores.

Additional Review Criteria - Administrative Core:

• Is the Administrative Core leader(s) qualified and experienced in the administration of a large, multi-component research program?
• Do the proposed core leader(s) have demonstrated competence in the area of science proposed and have a record of interacting and working well with other investigators at their institution and elsewhere?
• Do the Core leaders clearly describe how the scientific cores will draw upon the Administrative Core and how it will in turn respond to scientific core needs? Do the Core leaders clearly indicate the facilities, resources, services and professional skills that the Core will provide and how the collective operation of the Core will be achieved in a coherent manner?
• Are the opportunities for students and postdoctorates likely to provide them with a good understanding of the collaborative interactions driving the Conte Center research program and a broad background in the Conte Center research area? Are the plans to integrate Conte Center trainees with ongoing institutional training activities at the participating institution(s) appropriate?
• If a public outreach and dissemination plan is proposed, is it of high quality, and likely to reach a broad and diverse audience, and likely to increase science literacy?
• Are there plans for establishing and maintaining a Conte Center website targeted to a broad audience that describes the Conte Center and the implications of research supported by the Center for advancing our understanding of the biology of mental disorders?

Additional Review Criteria - Projects

• Does each project make an important contribution to the Center as a whole?
• Is each project well integrated with the scientific objectives of the Center?
• For each project, is an explanation provided as to how the contributions of each project will synergize with the rest of the Center to achieve more than could be achieved through an independent research project?
• Are the conceptual design, methods, and analyses for each project adequately developed, well integrated, and well-reasoned?
• Is each of the proposed projects feasible? Do the projects take advantage of any new methodologies? Are potential pitfalls identified or alternative approaches for the project and how these might impact on progress in the overall Center? Are available resources identified and is a clear explanation provided regarding how these resources will contribute to the success of the overall goals of the center?
• Is each project original and innovative?
• Are the proposed Research Project Leader(s) at the forefront in the area of science proposed with a successful record of bringing novel and potentially high-risk projects to fruition as the principal investigator? Do the individual(s) bring complementary and integrated expertise to the overall Center?

Additional Review Criteria - Research Support Cores

• Do the proposed core leader(s) have demonstrated competence in the area of science proposed and have a record of interacting and working well with other investigators at their institution and elsewhere?
• Are the Research Support Cores appropriate and necessary for the proposed studies?
• Do the proposed plans address the qualifications, past performance (if applicable), and time commitments of the Research Support Core Leader(s)? Is there evidence that appropriate expertise will be available to carry out the functions proposed for each core?
• Are the conceptual designs, methods, and analyses adequately developed, well integrated, and well-reasoned?

Milestones

Are appropriate, evaluative milestones clearly defined for the aims? 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)?

Study Timeline

Specific to applications involving clinical trials

• 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 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 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 individuals of all ages (including children and older adults) 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.

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIMH 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.

Applications will be assigned on the bases of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . 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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that 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.

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. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" 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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that 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).

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The awardee institution will comply with the NIH Guidance on Changes That Involve Human Subjects In Active Awards and That Will Require Prior NIH Approval.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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.

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 https://www.hhs.gov/civil-rights/for-individuals/section-1557/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 https://www.hhs.gov/civil-rights/for-individuals/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.

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.

Recruitment Reporting and Trial Registration:

NIMH requires reporting of recruitment milestones for participants in all NIMH extramural-funded clinical research studies proposing to enroll 150 or more subjects per study, and all clinical trials, regardless of size (see http://grants.nih.gov/grants/guide/notice-files/NOT-MH-16-013.html). This expectation will be stated in the notice of grant award.

The NIMH expects trial registration and results reporting for all NIMH-supported clinical trials, regardless of whether or not they are subject to FDAAA (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html). This expectation will be stated in the notice of grant award.

In the annual progress reports and in the final progress report, Center Directors will be asked to provide the following:

A discussion of how the Center activities advanced the state of the field in ways that are not possible through a series of independent projects.

A brief summary of the progress of each component (individual projects and cores) in the context of the overall goals of the Center.

A summary of the novel scientific interactions that were fostered by the Center.

Conte Centers may receive an administrative site visit during the third year at the time of their annual advisory board meeting.

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.

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, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Basic Neuroscience Applications:

Susan Koester, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health (NIMH)
Telephone: 301-443-3563
Email: [email protected]
Translational Applications (Adult):

Steven J. Zalcman, M.D.
Division of Translational Research
National Institute of Mental Health (NIMH)
Telephone: 301-443-1692
Email: [email protected]

Translational Applications (Developmental):

Julia L. Zehr, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1617
Email: [email protected]

Nick Gaiano, Ph. D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: [email protected]

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.