Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Complementary and Alternative Medicine (NCCAM)

Funding Opportunity Title

Center of Excellence for Research on CAM (P01)

Activity Code

P01 Research Program Projects

Announcement Type

Reissue of PAR-12-151

Related Notices

  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PAR-13-220

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.213

Funding Opportunity Purpose

This funding opportunity announcement (FOA) encourages the submission of applications that propose to conduct research that is of high-priority to NCCAM that requires synergistic collaboration between outstanding scientists and the synthesis of multiple research approaches by multi-disciplinary research teams. The Center of Excellence for Research on CAM (CERC) program is designed to support research in which the funding of three or four synergistic, highly meritorious projects as a group offers significant scientific advantages over support of the same projects as individual research grants.  Each CERC must consist of, throughout the duration of the award, a minimum of three research projects, focused on basic, mechanistic, and/or translational research questions relevant to the research priorities described in the current NCCAM Strategic Plan.

Key Dates
Posted Date

May 2, 2013

Open Date (Earliest Submission Date)

August 25, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

September 25, 2013 and September 25, 2014, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

January 7, 2014 and January 7, 2015, by 5:00 PM local time of applicant organization.

Scientific Merit Review

February/March 2014 and  February/March 2015

Advisory Council Review

May 2014 and May 2015

Earliest Start Date

July 2014 and July 2015

Expiration Date

January 8, 2015

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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

Required Application Instructions

It is critical that applicants follow the 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

The purpose of NCCAM's Centers of Excellence for Research on CAM (CERC) (P01) program is to support multidisciplinary, synergistic, multi-project research programs that have strong potential to advance the mission of NCCAM and to increase understanding of the mechanisms of action, optimal application, safety, efficacy and/or effectiveness of integrative/complementary health practices and their roles in improving health and health care. The basic criteria for a CERC are as follows:

 1. A clearly defined, unifying central theme to which each project relates and to which each investigator contributes. The CERC is directed toward a range of scientific questions having a central research focus, in contrast to the more narrow thrust of the traditional research project grant (R01). Investigators are strongly encouraged to carefully review NCCAM's Strategic Plan (http://nccam.nih.gov/about/plans/2011), which describes its long-range goals and the areas of high research priority that should be of direct relevance for potential CERC applications.

2. The inter-relationships of projects and collaborations among investigators will yield synergy (i.e., results beyond those achievable if each project were to be pursued independently). A CERC should not simply be a collection of three or four R01-level projects; rather, the projects (and optional research cores) should be chosen and designed such that the data from each of the projects informs upon the other projects and results in greater scientific impact than would have occurred had the projects been run independently.

3. A program director/principal investigator (PD/PI) who is an established research scientist and who has the experience, ability, and time commitment to ensure quality control, effective administration, and integration of all components of the Center. This person should be an investigator with a strong track record (which includes peer-reviewed research publications) in one or more research areas directly relevant to the focus of the proposed CERC, as well as a strong record of successful leadership of large research enterprises. Multiple PD/PIs are allowed. Refer to the following NIH Web site for details about requirements and leadership plans: http://grants.nih.gov/grants/multi_pi/index.htm.

4. Leadership of each research project by an experienced investigator(s) with an established record of productivity and independent funding. The participation of experts in several disciplines or several areas of one discipline should greatly enhance the goals of the CERC. All investigators must contribute to, and share in, the responsibilities of fulfilling the program objectives. Generally, it would be inappropriate to have a postdoctoral fellow or junior faculty (e.g., early-stage investigator) as a project leader.

5. Three or four projects that are judged to have significant scientific merit, as well as being complementary and contributory to the central theme of the CERC. Although investigators are allowed to submit a given project as a separate R01 application and as part of the CERC for review in the same review cycle, this practice is not encouraged. However, if such a project were to receive impact  scores that merit funding of both the R01 and P01 applications, funding of the project in the CERC will take precedence, and the R01 application will be inactivated administratively.

6. An administrative core.

7. One or more research core facilities that provide services to at least two research projects.

Investigators who are considering pursuing a collaborative approach to a high priority research problem are strongly encouraged to contact NCCAM program staff early in the process to discuss a potential application. The discussion could include the choice of funding mechanism, relevance of the topic to NCCAM's strategic plan and research priorities, and the scope and approach of the project. If the requested budget exceeds $500,000 in any grant year, then pre-approval is required (see Section IV.6 Other Information. Requests of $500,000 or more for direct costs in any year).

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. However, NCCAM anticipates making approximately 2 - 3 awards yearly for the duration of this FOA.

Award Budget

Application budgets are not limited but it is strongly recommended that applicants not request a budget of more than $1,250,000 in direct costs per year. These costs are exclusive of subcontract facilities and administrative costs.

Award Project Period

The maximum project period for these awards is 5 years. Starting with new and renewal P01 grants funded in fiscal year 2013, only one more renewal will be allowed.  

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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 not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) and component Project Leads that are not yet registered in eRA Commons must work with their institutional officials to register. Also, institutional officials at the applicant organization should ensure that the eRA Commons account for the contact PD/PI is affiliated with their organization.

eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

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

Eligible Individuals (Program Director/Principal Investigator)

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.   

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

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

2. Content and Form of Application Submission

It is critical that applicants follow the 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.

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

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core

6

Core (Use for Research Cores)

6

Project

12


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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF 424 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

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

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

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.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application. In the Biographical Sketches include a concise description of how the Center PDs/PIs have the following: (a) track record(s) of consistently producing highly significant research publications in one or more of the research areas proposed for the Center; (b) track record(s) demonstrating the ability to effectively and productively manage a large, interdisciplinary project in the proposed research area(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.

Budget (Overall)

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.

PHS 398 Research Plan  (Overall)

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

Specific Aims: Describe the specific aims for the Center as a whole.

Research Strategy: Provide information on the Center as a whole.  Discuss synergy of the components of the Center. Describe the institutional commitment by each participating institution, and describe prior productive collaborations of the research team(s). Describe the track records of the teams and investigators that provide evidence of a strong collaborative environment for the proposed Center

For renewal applications only, include a progress report that summarizes the aims and accomplishments of the Center during the prior funding period. See the SF424 instructions for details about what to include in the progress report. If a project from the prior funding period is being discontinued, explain in the overall progress report.

If the center involves clinical research, concisely describe overall plans for: 1) protection of human subjects from research risks; 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed; and, 3) the data in support of feasibility of recruiting sufficient participants from the proposed population(s) to achieve the stated objectives.   

Progress Report Publication List: For renewal applications, provide a list of all publications that arose from Center during the prior funding period. It is encouraged that this be arranged as a table in which publications are organized based on the following categories: a) overall Center (for publications that were not clearly related to a given Project); b) each Project; c) each Core (as appropriate). 

Letters of Support: Attach letters of support relevant to the center as a whole (e.g., letters of institutional support).  Letters of support relevant to specific projects or cores should be attached in the relevant Project or Core research plans.

Multiple PD/PI Leadership Plan:  If the Center will be directed by multiple PDs/PIs, a leadership plan should be included.

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

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

Administrative Core

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

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

Project Narrative:  Do not complete.

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

List all performance sites that apply to the specific component.

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

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

The Program Director/Principal Investigator (PD/PI) is the Center Director and head of the Administrative Core. The Director is responsible for the organization, scientific and administrative leadership of the CERC and is expected to devote substantial effort to the Center.

Budget (Administrative Core)

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

The Administrative Core may include limited funds for program enrichment activities such as seminars and research workshops. Funds from the center grant cannot be allocated for web site development or maintenance, newsletters, consumer information or outreach activities.

Support for the EAC must be explicitly budgeted in the Administrative Core. If it is anticipated that the EAC committee will include individuals who require travel expenses, these costs should be reflected in the administrative budget.

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

PHS 398 Research Plan  (Administrative Core)

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

Specific Aims: Describe the specific aims for the Administrative Core.

Research Strategy: The organization of the Administrative Core should encompass a support structure sufficient to ensure accomplishment of the following: coordinate the research mission, monitor timeline for achieving research milestones; coordinate and integrate Center activities; implement a plan for regular evaluation of scientific progress; interact with advisory groups (as appropriate); work with the applicant institution to enhance the visibility and effectiveness of the center as a focus for CAM research.  There should be a clear, detailed plan for managing the Center's research and administration, ensuring appropriate prioritization of research, needed course corrections and problem identification and resolution, and effective sharing of resources, that conveys a high likelihood of effective, productive management of the Center as whole 

The Administrative Core includes two advisory groups. An External Advisory Committee (EAC) will provide oversight and assist the Center Director in making scientific and administrative decisions. An Internal Steering Committee (ISC) composed of the Research Project and Core Leaders will meet regularly with the Center Director to assess research progress and determine if research goals are being met.

While the final administrative structure of the Center will be left to the discretion of the Center Director, experience demonstrates that effective development of a Center program requires interaction among the director, research project and core leaders, advisory groups, appropriate institutional administrative personnel, and NIH program staff. The Center Director may include a Project Manager/Specialist in the Administrative Core.

External Advisory Committee (EAC):  The Administrative Core will establish a scientific advisory board to review and provide guidance on Center activities. In addition to evaluating scientific progress of the Center, the EAC should periodically comment and report on Center operations to ensure that resources, especially core resources are devoted to the most scientifically worthy projects.

EAC members and the committee chair will be appointed by the Center Director in consultation with NCCAM; members may serve on a rotating basis. The Center Director will serve on the EAC in an ex-officio capacity only. The EAC should consist of at least three to six members in addition to the Center Director. EAC members may be employees of the grantee institution, participating institutions, or from outside institutions, but they cannot participate directly in the research of the Center.  If an EAC member becomes directly involved in the research of the Center, the resulting committee vacancy must be reported to NIH program staff and a replacement sought in a timely manner.

Applicants should not identify potential EAC members in their application. While description of EAC activities should be included in the application, potential members of the Board should NOT be contacted, named, or selected until an award has been made.  This stipulation will allow a wider pool of potential reviewers of the applications.

In addition to specifying the type of expertise needed, the applicant should also describe the process by which EAC members will be selected. The EAC should be established within three months of the start of the first budget period and meet once before the end of that period. Thereafter, the EAC shall meet at least once a year. Minutes of all (i.e., scheduled and ad hoc) EAC meetings must be kept. Minutes of the regularly scheduled meetings shall be sent to NIH staff within 30 days and also be included in the annual progress report..

Internal Steering Committee (ISC):  The ISC will meet regularly to assess research progress, resolve problems, evaluate utilization of core resources, and consider new research opportunities. Regular meetings of the ISC are intended to facilitate internal communication, cooperation, and interdisciplinary collaboration among Center investigators. The applicant should provide a plan for ISC meetings.

Administrative Core Progress (renewal applications only):  A progress report must be provided for the administrative core in renewal applications. Provide the beginning and ending dates of the most recent award period. Summarize the specific aims of the core during this period and the importance of the accomplished activities. Provide justifications for major changes in the core.

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

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

Research Core

When preparing your application in ASSIST, use Component Type ‘CORE.’

Research cores are not required, but one or more such cores are allowed, and any proposed core must be used by at least two 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 Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research 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.

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

Budget (Research 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 Core)

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

Specific Aims: Describe the specific aims for the Research Core.

Research Strategy: The Research Cores provide infrastructure and result in increased productivity contributing to synergy of the research effort as a whole. If a Research Core is included, then it must be utilized by a minimum of two research projects. It is expected that leaders of the research cores will participate in developing the conceptual framework for the research conducted by the center. 

While the Research Core(s) may function primarily as a service entity, core scientists are often involved in conducting original and developmental research. For example, proteomics and mass spectrometry cores may develop new methods and innovative procedures essential to advancing the research of the center. 

Core resources should not duplicate resources already available to Center investigators. However, fee-for-service core components (i.e., Center use of existing facilities) are acceptable with adequate justification.

For renewal applications, discuss progress in this Core during the prior funding period, and the rationale for changes.

Progress Report Publication List:  Include a list of publications that arose from this Core during the prior funding period.

Letters of Support:  Include letters of support relevant to the core only

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

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

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:

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 include.

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)

Budget (Project)

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 (Project)

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

Specific Aims: Describe the specific aims for the Project.

Research Strategy: Describe the research strategy for the project. Even though it is required that the three or four research projects included in the CERC be synergistic, this section should focus on this specific Project and not the potential synergy between this Project and the other projects and/or cores.  Synergy should be discussed in the Overall component.

For renewal applications, include a Progress Report that discusses the progress in this Project during the prior funding period, and the rationale for significant changes that may have occurred during the prior funding period.

Progress Report Publication List:  Include a list of publications that arose from this Project, during the prior funding period.

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

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

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.   

6. Other Submission Requirements and Information

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 Applying Electronically.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff 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.

Although a written "Request for Permission" is due at least 6 weeks prior to the application due date, NCCAM strongly encourages investigators to submit the request for permission much earlier in the cycle (e.g., 3 - 5 months prior to the application due date). This can significantly aid the investigators in the subsequent development of the application itself. NCCAM reviews pre-approval on a rolling basis and typically will inform investigators within 4 weeks of submission of the pre-approval request whether they will be allowed to submit an application. The request can be sent as a single attachment (PDF) to an e-mail (this is the preferred method) or by regular mail to the NCCAM Scientific/Research Contact listed in Section VII. Agency Contacts.

The following criteria will be used in the administrative staff review of these requests:

1.  Relevance to NCCAM: How is the unifying central theme important to the NCCAM mission?

2.  Programmatic priority: How will the proposed research significantly advance the mission of NCCAM? Does it address an area of high research priority as described in the NCCAM Strategic Plan?

3.  Programmatic balance: How does the proposed research relate to currently funded research by NCCAM, by NIH at large, and by the investigative team?

4.  Grant mechanism: Are there three or four discrete, R01-level projects and if research cores are proposed, would the core(s) serve at least two projects? Is the proposed work appropriate for the P01 grant mechanism?

If NCCAM agrees to accept an application, a cover letter should be included with the application that identifies the NCCAM program staff who agreed to accept assignment of the application to NCCAM. NCCAM will also notify the NIH Division of Receipt and Referral of the willingness to accept the application.

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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

Overall Impact - Overall

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).

Scored Review Criteria - Overall

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.

Significance

Does the center address an important problem or a critical barrier to progress in the field? 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?   

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do(es) the Center PD(s)/PI(s) have: (a) track record(s) of consistently producing highly significant research publications in one or more of the research areas proposed for the Center; (b) track record(s) demonstrating the ability to effectively and productively manage a large, interdisciplinary project in the proposed research area(s)? 

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 
If the center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  Is there adequate data in support of feasibility of recruiting sufficient participants from the proposed population to achieve the stated objectives? 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of substantial institutional commitment on the part of each participating institution?  Is there evidence of prior productive collaboration of the research team (including in the P01 application)?  Are the application and investigator track records indicative of the establishment of a strong collaborative environment for the program project?        

Additional Review Criteria - Overall

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.

Synergy

In assigning the impact score for the application as a whole, although primary emphasis will be placed on scientific merit of the research projects, the assessment of scientific synergy (i.e., the extent to which the potential for scientific impact of the proposed CERC as a whole is deemed likely to be greater than the sum of its component research projects and cores) should contribute significantly to the overall score.

Each application will receive a merit descriptor (highly synergistic, synergistic, not synergistic) that reflects the degree of synergy of the proposed CERC.

In particular, program synergy will be evaluated on the extent to which the combined approaches to the research question proposed for the CERC are synergistic, and the integration and parallel pursuit of the projects and cores are likely to advance this research area to a greater extent than could be achieved without Center support. This will include the following:

Renewal - Progress Report

For renewal applications, the progress should be evaluated for accomplishment of objectives for each of the prior projects, research cores, and the Center overall. Have investigators clearly and concisely described, for each project, core, and Center overall the specific aims, whether they were achieved, and what peer-reviewed articles were published that present the data related to those specific aims? Were the data published in high-impact journals? Were the quality and quantity of publications resulting from the prior center grant appropriate for the research that was proposed?    

Review Criteria for Individual Research Projects

Reviewers will consider each of the review criteria below in the determination of scientific merit of each proposed research project, and give a separate numerical (1 to 9) score for each criterion, as well as an overall impact score for the project. A project does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the Project leader and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative, do the investigators have complementary and integrated expertise; are their leadership and research track records appropriate for the project?

Innovation

Does the proposed project challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  

Approach

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

If the project involves human subjects research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is there adequate data in support of feasibility of recruiting sufficient participants from the proposed population to achieve the stated objectives?

Environment

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

Review Criteria for Administrative Core

The Administrative Core, if included, will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects:

Are there adequate plans for use of an External Advisory Board and an Internal Steering Committee to provide scientific and managerial oversight?   

Review Criteria for Research Cores

Each Core will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects:

Additional Review Criteria - Overall, Administrative Core, Research Cores, and Projects

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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.

Renewals

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

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not 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.

Additional Review Considerations - Overall, Administrative Core, Research Cores, and Projects

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Applications will be assigned on the basis 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

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

2. Administrative and National Policy Requirements

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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

Scientific/Research Contact(s)

Partap S. Khalsa, DC, PhD, DABCO
Program Director, Division of Extramural Research
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-3462
Email: partap.khalsa@nih.gov

Peer Review Contact(s)

Dale Birkle Dreer, Ph.D.
Chief, Office of Scientific Review
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-451-6570
Email: birkled@mail.nih.gov

Financial/Grants Management Contact(s)

George Tucker, M.B.A.
Chief Grants Management Officer
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-9102
Email: gt35v@nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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 Parts 74 and 92.


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