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

Core Center of Excellence Grants are intended to bring together investigators currently funded by NIH or other Federal or non-Federal sources to enhance the effectiveness of existing research and also extend the focus of research to substance use/misuse and addiction. A Core Center of Excellence should support innovation and be on the cutting edge of science. Incremental work should not be the focus of Center Activities. It is expected that research activities will cross a variety of disciplines to bring multiple perspectives and approaches to bear on significant problems. The Center should reflect thematic integration so that the Center does not support a collection of independent research projects. Multidisciplinary interactions in the Center are expected to have a synergistic effect that results in greater depth, breadth, quality of research and productivity beyond what is possible among individual research projects.

The applicant may propose pooling of existing core resources and request additional support for developing a shared research infrastructure. The research infrastructure support may include, for example, administrative coordination, subject recruitment, equipment, laboratories, statistical analysis, quality control, and database management. It should be made clear how this Center support would enhance a minimum of 3 separate federally funded research project grants at any time, with at least 2 distinct Program Directors/Principal Investigators PD(s)/PI(s) and result in programmatic coherence, synergy and integration. Applicants must demonstrate the potential for the continuation of funding of participating research project grants, and there must be at least two years of funding left for each grant identified at the time of submission. Funds may be requested for pilot research projects.

A NIDA P30 Core Center of Excellence grant must contain an administrative core and one or more research support cores, providing centralized resources and facilities for funded research projects that will be directed to new research in substance use/misuse and addiction. These may include, but are not limited to, genetics, proteomics, medication development, molecular, cellular, organ, system, developmental, behavioral, clinical, treatment, social, epidemiology, prevention, health services and AIDS. A Core Center must also contain a core to support pilot projects.

In addition, NIDA P30 research Centers are expected to serve as national research resources in the substance use/misuse research field. They are expected to attract established and promising investigators into substance use/misuse research, as well as for community outreach to enhance effective dissemination of research findings. In addition, the Center is also expected to provide research opportunities and experiences to new investigators.

Special Considerations

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at http://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see http://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding- for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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.
• o 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

Office of Extramural Policy and Review
NATIONAL INSTITUTES OF HEALTH

NIDA/DER/OEPR

3WFN 9th floor MSC 6021

301 NORTH STONESTREET AVE

BETHESDA MD 20892

The letter of intent should be sent to: [email protected]

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

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.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Research Support Cores: required
• Pilot Research Project Core: required

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.

Facilities & Other Resources: The application must document availability of appropriate and adequate facilities dedicated to the conduct of administrative, shared resource, and research activities. While all members of the Center need not be located physically in facilities controlled exclusively by the Center, there must be a clearly identifiable physical location which insures adequate administrative oversight for the Center and associated core units that are providing shared resources. Describe the types and quality of shared laboratory and clinical facilities.

Other Attachments: The following information must be loaded as separate PDF attachments. The filename provided for each attachment will be the name used for the bookmark in the application image.

Center Organizational Structure. Applicants must include a diagram of the organizational structure of the Center. This diagram should demonstrate how the interactions among the Center components will achieve the stated goals of the Center. The diagram should be attached as a PDF, titled "Center Organizational Structure" In addition, .

Table of Research Core Utilization. A table must be provided that indicates the percentage use of each core relative to the individual projects, if Research Cores are included in the application. The table should be attached as a PDF, titled "Table of Research Core Utilization".

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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.

The PD/PI (Center Director) should be an outstanding, productive, senior researcher, as documented by scientific achievements, publications, patents, honors, and track record of leading large groups and similar indices of stature. The Center Director should have the ability to lead administrative and operational aspects of the Center, as noted by administrative skills, achievements, and planned activities and there should be evidence of ability to develop or maintain a role for the Center as a national resource.

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 and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Concisely state how the goals and objectives of the NIDA Core Center of Excellence will enhance the research base; include potential impact, any areas of special interest, and any research ideas, disease entities, and target populations to be studied.

Research Strategy: Describe how the NIDA Core Center of Excellence will serve its research base, including the required significance, innovation, and approach. Include an overview of the scientific focus of the ongoing research projects in the research base of the Core in sufficient detail to allow reviewers to judge the extent and the interrelationships of ongoing research. There should be a clear integration of the Center and it's components -Cores and Projects- around an overarching theme that integrates and focuses the Center, as well as the presence of an essential relationship of each research project and core component to the theme. How Center members interact, the quality and productivity of the research programs, demonstrated or potential interdisciplinary collaborations, and how establishment of a Core Center will further extend, stimulate and provide added dimensions to the current research activities are all important considerations. The qualifying research projects have been through peer review, establishing the quality of the individual funded projects, so important aspects will be: (1) interactions and interrelationships of the research efforts; (2) uses and benefits of core services; and (3) plans to continue/develop productive collaboration among Core investigators. Documentation of a collaborative environment may be included (listing co-authored publications from PDs/PIs). It is suggested that each of these activities be presented under separate subheadings in the Research Strategy.

Explain how each core support will enhance ongoing research projects beyond currently available resources, promote collaborative research and/or attract new investigators to the field, provide enhanced or increased efficiency of services, and/or offer services that are new, unique or otherwise unavailable on individual grants. Describe how each individual core fit in and contribute to the innovation of the overall Core Center. Discuss the relevance and inter the separately funded ongoing research projects to the central theme of the Core Center of Excellence. Explain how meaningful collaborations are going to be established between the Core Center and the greater substance abuse research community to make the Center a national resource. In addition, describe innovative ways the Core Center will communicate, allocate resources to promote new cross-departmental or multi-disciplinary collaborations, or integrate activity across basic and clinical fields.

Discuss how the translational components are designed to enhance potential collaborations leading to public health advances. If present, describe how translational components are well designed to enhance potential collaborations leading to public health advances.

No single core should be used more than 50% of the time by a single PD/PI. If a proposed core is not to be used 100% of the time by all of the investigators associated with the Center explain why.

Provide a table of the ongoing research projects that will interact with the Center. The required minimum number of qualifying research projects in the research base of a Core Center is three, and each must have at least two years of support remaining at the submission date of the P30 application. Use columns for the PD/PI’s last name, the PD/PI’s % effort on the project, the funding source e.g., R01 DA999999, the project end date (not just the current year of support), the annual direct cost, and the project title. Use one row for each project (a PD/PI holding more than one grant will appear on more than one row), and wrapping text within columns is allowed. For listed qualifying projects that are not funded by NIDA, add a justification sentence at the bottom of the table for each, stating how it relates to NIDA’s mission areas. If relevant, a second table may be included for Additional Funded Projects planning some use of Core facilities.

Preliminary Studies/Progress Report: This part of the Research Strategy is especially important for renewals or revisions; for new applications, this section may be shorter and may include examples of previous/ongoing services/techniques that have provided increased productivity within the research environment. Renewal applications use this section to document the impact the NIDA Core Center of Excellence has had on research accomplishments, shared resources, new collaborations, and other outcomes enabled by the core as well as providing services as a national resource. Provide information on core usage and other benefits to the scientific research enterprise and note any specific problems in core administration and management.

For Renewal Applications Only: Renewal applications must document progress in the Approach part of the Research Strategy section. A Progress Report should describe the impact of the Center, including evidence of PD/PI interactions with each other and recruitment of additional investigators to the substance abuse field. A Renewal application should also include: a summary of major accomplishments that can be attributed to the Core Center program, clearly emphasizing accomplishments beyond those possible from the existing support to the individual grants in the research base. Include the significance of the resources contributed by the Research Support Cores to the projects in the research base; provide evidence that the Core Center shared resources effectively and efficiently and of the extent of core use by individual PD/PIs in the research base; describe the effectiveness of the Core Center in facilitating collaborations or helping to attract investigators to substance abuse research. Any data-sharing activities undertaken as part of the Core activities should be described and any other information that is considered directly attributable to the use and conduct of the Core Center.

It is especially important that a renewal propose innovative work for the new funding period. Changes in the Specific Aims, including termination of Research Components or Cores, should be described and justified and major findings presented with clear descriptions of the importance of these findings to advances in the field. The application should also address any significant organizational changes and provide a summary of the career development opportunities and mentoring provided to junior investigators as well as results of education and dissemination activities. Centers that conduct clinical trials must also provide a summary of results and conclusions based on the clinical trials supported by the Center.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. NIDA Centers are supported both for their expected crucial scientific accomplishments and for their role as vital resources to the research community. In order to maximize the impact of their work, they are expected to make their data, their methodologies and their findings available in a timely manner to other researchers and those who have a legitimate purpose for the access. In most instances, the data sharing is expected to extend beyond that of one's own Center to the research community. This sharing can be accomplished in many ways, including posting findings on the Center's website or using archival services. Data sharing plans are expected to be provided, consistent with achieving the goals of the program. A plan for development and dissemination of assessments and methodologies and a general publication plan are also expected. The adequacy of the sharing plan will factor in programmatic decisions on whether to fund an application. Investigators are expected to provide Research Resource Identification (RRID) in any publication for any research resource supported by this FOA using http://scicrunch.org/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.

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

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 Center Director 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.

In developing the budget, applicants should take into account funds currently available through existing collaborating grants and explain how these funds might be reconfigure d to maximize efficient resource utilization. The Center is intended to provide reasonable support for activities clearly related to the specialized research needs of the Center.

It is expected that the Center director will commit at least 2.4 person months effort to Center administration including the Administrative 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.

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

Specific Aims: Concisely describe the goals and objectives of the Administrative Core Center

Research Strategy: The Administrative Core is expected to have a scientifically and administratively qualified Center Director with responsibility for the scientific, administrative, budgetary, and operational aspects of the Center. Describe how the Center Director will be responsible for overall coordination and development of the Center with the responsibility to provide leadership essential to the success of the Center program, to ensure interaction and collaboration among scientists conducting research, to monitor ongoing research and identify (with the assistance of colleagues) research and educational activities to be expanded or decreased and needs for additional resources or reallocation of resources.

Describe how the Administrative Core will have appropriate and effective administrative and organizational capabilities to support multidisciplinary research, to foster synergy, and to support planning and evaluation activities. Describe how administrative and organizational arrangements should promote joint planning and evaluation activities as well as collaborations and interactions within, between and among programmatic elements of the center. This should include: (a) an overall programmatic structure that effectively promotes scientific interactions, provides for internal quality control of research and publications, generation of future grant applications, and also takes maximum advantage of the Center’s substance use/misuse research capability (the description of these attributes is particularly important when there are multiple participating institutions in the Center); (b) an administrative organization that has clear lines of authority, is managed efficiently and cost effectively, and enables effective use and leverage of resources; (c) the use of an external advisory structure that is charged to provide appropriate and objective advice and evaluation, as needed, to the Center Director; (d) an internal advisory, decision-making, and priority setting process to support the activities of the Center; and (e) appropriate criteria and processes for determining and sustaining individual participation in the Center based on productivity, research direction, and overall contribution.

Describe how the administration of the NIDA Core Center will enhance the research base activities, including the required significance, innovation, and approach. The PD(s)/PI(s) provide scientific and administrative leadership for the Center and must have demonstrated ability to coordinate, integrate, and provide guidance in establishing multi-faceted research programs. Describe the administrative framework to manage the NIDA Core Center and each core, including the roles of the Center Director(s) and Research Support Core Directors, the lines of authority and relationship to appropriate institutional officials, how access and utilization of services will be prioritized, how potential disputes will be resolved, and how periodic evaluations will be used to improve the services. Describe how the proposed Administrative Core will foster developing close interactions among the Administrative Core Center Director(s), Research Support Core Directors, the PD/PIs of the funded projects utilizing the core, and appropriate institutional administrative personnel. In addition, describe Enrichment Program activities, such as use of seminars, visiting scientists, workshops and use of consultants, that might contribute to the objectives of the NIDA Core Center of Excellence.

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

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

Appendix:

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

Research Support Core

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

A Research Support Core can be a laboratory, a facility, a service, or other shared resource that supports other Center components in their activities. Research Support Cores are expected to support at least two federally funded Research Projects and each Research Support Core should be clearly described in terms of the services and resources to be provided to other Center components and research projects.

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.

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.

Budget (Research Support Core)

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

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

PHS 398 Research Plan (Research Support Core)

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

Specific Aims: Concisely describe how this Research Support Core will provide new services to the individual ongoing grants beyond what is currently available, and/or increase effectiveness by sharing expertise or centralizing labor-intensive tasks, how it will encourage and facilitate collaborative work, or promote public health advances. Include impact beyond the qualifying users, if applicable to other users of the core.

Research Strategy: Issues to be addressed include quality control, procedures for selecting projects that use the Core, cost effectiveness, and increased efficiency. Training in complex techniques and methods should be described if they are functions of the proposed cores. Core components are intended to enhance opportunities for investigators at the Center to include new technologies that broaden their research initiatives. While research per se is not an essential part of a scientific core, quality assurance activities that evaluate its operations and are directed at problem identification and improvement of core functioning are appropriate.

Describe how the Research Support Core facilities or services will enhance research activities of the projects using this core and add benefits to the research accomplishments; include the required significance, innovation and approach. Include how the Research Support Core will provide increased or innovative capabilities; facilitate increased productivity or effectiveness through sharing expertise or centralizing labor-intensive tasks; and/or foster collaborative or new research directions, including bridging basic and clinical goals or attracting new investigators into an area. Each proposed technique or service in the Research Support Core, and its current status of staffing, should be described in enough detail to allow a comprehensive evaluation. Existing methodologies already in use may be described briefly; methodologies new to the institution need to be described in greater detail and strategies delineated for successful implementation. Include any developmental methods for research or training, if proposed. If applicable, include sections on quality control. It is critical to document benefits of the core’s activities to the existing research base.

Include plans for administration, organization and proposed management of the Research Support Core. Administrative organization is a critical part of the application. Include plans to implement core services, prioritize investigator use among projects competing for core use, and how potential disputes will be resolved. If the core is used to train investigators in special techniques, describe the nature and extent of this training and the qualifications of core personnel to provide and oversee this training. Specifically address the strategies for integrating the resources of the Research Support Cores with resources already provided to the research base. Describe how this integration of resources expands the capability of the research base.

Letters of Support: Include letters of support if appropriate.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan and Resource Sharing Plan. NIDA Centers are supported both for their expected crucial scientific accomplishments and for their role as vital resources to the research community. In order to maximize the impact of their work, they are expected to make their data, their methodologies and their findings available in a timely manner to other researchers and those who have a legitimate purpose for the access. In most instances, the data sharing is expected to extend beyond that of one's own Center to the research community. This sharing can be accomplished in many ways, including posting findings on the Center's website or using archival services. Data sharing plans are expected to be provided, consistent with achieving the goals of the program. A plan for development and dissemination of assessments and methodologies and a general publication plan are also expected. The extent to which a NIDA Center is a resource to the field by developing and sharing data, methodologies and findings is a major factor in the potential value of a Center and is therefore an important factor in the decision by NIDA program to fund a Center application. All components and project are expected to adhere to Data and Resource Sharing Plan. To facilitate replication of studies and validation of reagents investigators are expected to provide Research Resource Identification (RRID) in any publication for any research resource supported by this FOA using http://scicrunch.org/resources

Appendix: 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 NIH-defined human subjects research, clinical research, and/or 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: All instructions in the SF424 (R&R) Application Guide must be followed.

Pilot Research Project Core

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 (Pilot Research Project 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 (Pilot Research Project Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Research Project Core)

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

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

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

Project /Performance Site Location(s) (Pilot Research Project 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 (Pilot Research Project 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.

Budget (Pilot Research Project Core)

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

A Pilot Research Project Core may not have an annual budget exceeding 10% direct costs of the annual budget for the NIDA Core Center.

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 (Pilot Research Project Core)

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

Specific Aims: Specific Aims are required

Research Strategy: Applicants may propose and request funding in the first year for specific, already conceptualized pilot projects and also for pilot projects to be added in subsequent years of the project. Applications requesting support for pilot projects must describe a process for within-Center scientific review of new pilot projects to be initiated in future years of the project and a process for evaluation of ongoing pilot projects for adequate progress. The application may also describe each pilot project proposed for the initial year of support. Pilot projects presented in the application will be reviewed as part of the assessment of scientific and technical merit of the application. Applicants are encourage to provide examples of the kinds of pilot projects the Center might initiate in the future as a result of its internal within-Center review process. Pilot projects may be used for new, early stage or independent investigators and should represent new projects to develop and explore new activities or directions or take advantage of special opportunities. Pilot projects may be research and development pilots, feasibility studies, or other pilot work broadly defined as foundation work for further research. Pilot projects may not be used to supplement or prolong ongoing research and should not be used as bridge funds when other research support is no longer available.

Applicants should explain how Pilot projects will recruit Early-Stage Investigators and established investigators new to substance abuse research or permit established investigators to change research direction.

The support of individual pilot project studies is typically of relatively short duration (e.g., 1-2 years), depending upon the nature of the research.

Letters of Support: Include letters of support if appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan and Research Resource Sharing Plan. NIDA Centers are supported both for their expected crucial scientific accomplishments and for their role as vital resources to the research community. In order to maximize the impact of their work, they are expected to make their data, their methodologies and their findings available in a timely manner to other researchers and those who have a legitimate purpose for the access. In most instances, the data sharing is expected to extend beyond that of one's own Center to the research community. This sharing can be accomplished in many ways, including posting findings on the Center's website or using archival services. Data sharing plans are expected to be provided, consistent with achieving the goals of the program. A plan for development and dissemination of assessments and methodologies and a general publication plan are also expected. All components and project are expected to adhere to Data and Resource Sharing Plan.

Appendix: Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Pilot Research Project Core)

When involving NIH-defined human subjects research, clinical research, and/or 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: All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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

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

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

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

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: 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.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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.

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?

Specific to this FOA:

Is the proposed Center scientifically compelling? Is there a strong coordination and synergy among the proposed Cores towards achieving the scientific goals of the Center?

Does the proposed Center add value to the existing substance use research activities at the applicant institution(s)?

Are the proposed Cores and Project well integrated? Do the Center’s activities involve different scientific disciplines or subdisciplines and demonstrate substantial interaction among scientists from different disciplines or subdisciplines and different perspectives?

Does the proposed structure and organization of the Center enhance scientific communication, outreach, synergy, and training efforts?

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?

Specific to this FOA:

Does the proposed plan for the Center's leadership demonstrate sufficient scientific and managerial experience, leadership skills, and time commitment to achieve success of the Center? Are there plans for development and maintenance of an environment that promotes the conduct of the highest quality of research, innovation, and leadership?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, 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?

Specific to this FOA:

What is the level of innovation in plans for promoting multi-disciplinary collaborations within and across basic and clinical research fields? How do individual Cores contribute towards the innovation of the Center?

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 Core 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?

Specific for this FOA:

Additional Review Criteria - Administrative Core

Is the organizational structure and plans for coordination and development of the Center adequate for effectively managing its activities? Is a plan to prioritize, allocate and manage fiscal resources adequate? Are plans for promoting thematic integration of research activities well developed? Does the application provide sufficient detail about how success of individual Cores, Pilot Projects, and the Center will be evaluated?

Additional Review Criteria - Research Support Cores

Are the Research Support Cores well integrated? Does each of the proposed Research Support Core provides opportunities that are not otherwise available to the investigators? Are there adequate plans to evaluate allocation of resources, user prioritization, quality control and utilization of services? What is the likelihood of Research Support Cores fostering collaborative and/or new research directions and increasing research productivity?

Additional Review Criteria - Pilot Research Project Core

Are the proposed pilot projects appropriate for receiving support from the Center? Is the plan for evaluating the pilot projects well developed? Are appropriate plans in place for attracting new researchers to the field of substance use research using pilot projects?

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 approach 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?

Specific for this FOA:

Does the application include appropriate plans for leveraging and capitalizing on existing institutional resources to support the activities of the Center; for example, letters of support, space and resources to be allocated from the applicant institution, substantial commitment to the Center and appreciation of its goals and role in public health, especially in the substance use/misuse and addiction research field?

Are there appropriate and adequate facilities for administrative, research, and shared resources, including a clearly identifiable physical location for the Center, which assures necessary functions can occur?

What is the likelihood of this Center becoming a national scientific research resource for substance use research?

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.

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. In addition, for renewal applications:

• To what extent did the Pilot Research projects support investigators previously listed? To what extent have previously supported projects been successful?
• Have activities established the Center as a national resource?
• Have the benefits of the Center been documented in the forms of increased collaboration, new research directions, and cost savings?
• Are data provided to document the outcome of all pilot research projects completed in the last five years, including those that failed to lead to further funding?
• Have the cores provided new methods, techniques, and/or resources and developed ways to support investigators in new areas of research, as appropriate to the purpose of the Center and the research supported by the Center?
• Are the use, utility, quality control, and cost effectiveness of each core requested to continue as part of the Center documented? Are cores no longer needed appropriately being discontinued in response to the changing needs of Center investigators?
• Is there a significant list of publications arising from each core in renewal applications?
• Has the administrative structure proven effective? Has the enrichment program been effective?
• Does the renewal propose innovative work for the new funding period?

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

As applicable for the 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.

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

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 .

Authentication of Key Biological and/or Chemical Resources