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National Center for Complementary and Integrative Health

NCCIH Policy: Applications for Centers of Excellence for Research on Complementary and Integrative Health (P01) Over $500,000 in Direct Costs in Any Year

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A. Purpose

This document describes the National Center for Complementary and Integrative Health (NCCIH) policy requiring documented approval from NCCIH before investigator-initiated P01 applications can be submitted.

B. Scope

This policy applies specifically to investigator-initiated new, renewal (competing continuation), resubmission (amended), or revision (competing supplement) P01 applications requesting $500,000 or more in direct costs in any one year. First-tier consortium or contractual facilities and administrative (F&A) costs do not count against the direct cost threshold.

Prospective applicants should refer to Section IV (Application and Submission Information) of the current funding opportunity announcement (FOA) for detailed information about the required components of a P01 application package. This document describes the procedure required for researchers to request NCCIH’s permission to apply.

C. Process

To obtain NCCIH permission to submit a P01 application, a potential applicant must:

  • Discuss the proposed Center of Excellence for Research on Complementary and Integrative Health (CERCIH) application with NCCIH program staff 4 to 6 months prior to the planned application receipt date.
  • Submit a letter of request for permission to apply to NCCIH at least 6 weeks prior to the planned application receipt date.

Contact Program Staff

This communication is the first step in requesting approval to submit a P01 application. It is a discussion between an NCCIH Program Director and the principal investigator (PI) and key personnel of a proposed CERCIH. To adequately prepare for this discussion, the PI should provide the relevant NCCIH Program Director with a 2 to 3 page summary of the concept for the CERCIH. This communication with NCCIH staff: (1) ensures that NCCIH receives applications that are scientifically aligned with NCCIH’s mission and strategic vision, and (2) enables NCCIH to consider the budgetary impact of supporting such a project.

Letter of Request for Permission To Apply

The prospective applicant(s) will be notified via email if they are being invited to submit a letter of request for permission to apply (RPA). This RPA serves as the formal request from the PI seeking permission to submit a CERCIH application. In the event NCCIH determines the proposed application does not fit with the goals and objectives of the CERCIH Program, the PI will be provided feedback as to why the proposal was not a good fit and what other options are available to support the proposed work. For NCCIH to make an informed decision about whether permission will be given to apply, the RPA should be approximately 8 to 12 pages in length and include or address the following:

  • The title of the proposed project
  • The submitting organization or institution
  • The anticipated application receipt date
  • The key personnel (the eRA Commons user ID must be included for the PI or contact PI)
  • Specific aims of the any subprojects
  • The significance of the proposed research
  • The relevance of the research to the NCCIH mission and strategic plan
  • How the research would significantly advance the field rather than producing incremental progress
  • How the proposed research is consistent with the relevant funding opportunity announcement and budget guidelines
  • Justification for why the proposed projects need to be conducted in parallel within the constraints of the CERCIH paradigm rather than as separate, stand-alone projects (e.g., funded by R01 grants)
  • Likelihood of synergy arising from or occurring between the projects and optional research core[s]
  • Outline of preliminary evidence that supports the feasibility of the proposed studies
  • The direct costs, subcontract F&A (if any), and total costs for each year of the proposed project using one of the two tables provided via the following link (funds and value of goods or services provided by third-party contributors* must also be included): $500K Budget Tables (40KB Word doc)

The Letter of Request should describe the specific aims of each proposed research project or core. The projects should each be hypothesis driven and unified by an overarching hypothesis for the entire Center. Investigators must also describe how the proposed research would likely achieve synergy among the multiple projects, which is an essential aspect of CERCIH grants. For the purpose of the CERCIH FOA, “synergy” is referring to a combined effect that is greater than simply the sum of the parts, and that just having a central theme, while necessary, is not sufficient to establish synergy. Further, projects may be well “integrated” as a whole, but still not achieve synergy. Applicants should describe how each project is necessary to test the overall hypothesis. Of note, the CERCIH program will not accept applications that propose clinical trials of efficacy or effectiveness as the primary outcome in any of the projects.

*Proposed third-party support: A letter notifying NCCIH about any proposed third-party support, the estimated commitment level, and possible contingency plans in the event that the third-party support is terminated during the research project should be submitted by the PI at the same time as the letter of request. This letter is non-binding and is for planning purposes only. If NCCIH decides to fund the application, prior to the Notice of Award NCCIH will request that the grant applicant’s Authorized Organization Representative (AOR) submit a formal Third-Party Contribution Agreement signed by the third party’s AOR. In addition, NCCIH funding of an application with third-party support may be contingent on securing co-funding from those sources.

Criteria for NCCIH’s Decision

NCCIH considers the following criteria in determining whether to give permission to apply:

  • Relevance to NCCIH: Importance of the central theme to the NCCIH mission and strategic plan. Will the proposed research significantly advance the mission of NCCIH?
  • Programmatic priority: Is the proposed set of projects in an area that has been determined to be a high priority for NCCIH?
  • Programmatic balance: How does the proposed research relate to currently funded research by NCCIH and by the investigative team? Is the proposed work an incremental advance to other work supported by NCCIH or is it truly innovative and will significantly advance the field?
  • Activity Code: Is the proposed work appropriate for activity code (i.e., funding mechanism) and FOA guidelines, and are the proposed annual costs reasonable?
  • Likelihood of synergy arising from or occurring between the projects and optional research core[s]
  • Is there a strong rationale and justification for why the proposed projects need to be conducted in parallel within the constraints of the CERCIH paradigm? Have the investigators provided justification for why the projects could not be conducted as separate, stand-alone projects (e.g., funded by R01 grants)?

Notification of NCCIH’s Decision

Within 3 to 4 weeks of receipt of the letter of request, NCCIH will notify the applicant in writing about its decision (or request additional information on the proposed application). The PI will receive a letter indicating that NCCIH has given permission to submit the application and the maximum budget that will be allowed in the application.

Please note: Giving permission to submit an application does not guarantee that NCCIH will fund the application or that it will fund the application at the requested levels, regardless of the outcome of peer review.

Submitting the Application

To facilitate the receipt of the application, applicants must include a cover letter with the application that identifies the NCCIH program staff member(s) with whom they have been in contact regarding the application. The second page of the cover letter should be the documentation from NCCIH granting permission to submit the P01 application. If the Subtotal Direct Cost on the cover page of the application exceeds the amount NCCIH agreed to accept, the application may be withdrawn or not awarded.

Instructions for Resubmission (Amended) Applications

NCCIH’s decision to give permission to apply for a specific receipt date automatically allows applicants to submit a single amended application (i.e., an “A1” application), provided that:

  • The submission of the A1 application occurs within 37 months of the original receipt date for the initial new (A0) application, in accordance with NOT-OD-10-140
  • The sites and subcontracts of the A1 application are the same as the original application
  • The originally proposed scope remains unchanged
  • The total direct costs per year do not exceed the amount NCCIH originally agreed to accept (excluding increases in PI salaries due to changes to the NIH salary cap).

Contingent on meeting the requirements above, an applicant intending to submit an amended (A1) application does not need to submit another letter of request. However, NCCIH requests that every applicant intending to submit an A1 application first submit a letter of intent so that NCCIH can plan for the receipt, referral, and review of the A1 application. See the “Note” below for specific instructions.

If a resubmission (A1) application does not meet all the conditions above, the applicant must initiate a new round of discussions with NCCIH staff and submit a new RPA. Changes that would require restarting the request for permission to apply process might include changes in projects or cores as well as their specific aims or their leaders.

Note: NIH policy requires documented NCCIH permission for every submission of an application with subtotal direct costs equal to or exceeding $500,000 in any one year, and NCCIH staff members need to take administrative actions so the Center for Scientific Review can accept a resubmission (A1) application for peer review. Therefore, applicants must inform NCCIH staff about the intended receipt date to which they plan to submit the resubmission (A1) application. The most effective and preferred method to notify staff about the intended submission of an amended (A1) application is through a letter of intent to the appropriate program director, with a separate copy to the Director, Office of Scientific Review, at least 6 weeks prior to submitting any resubmission application. This letter should include:

  • Receipt date and NCCIH Advisory Council round for the intended submission
  • Descriptive title of proposed research
  • Name, address, and telephone number of the PI
  • Names of other key personnel
  • Participating institutions (highlight the name of the submitting institution)
  • Number and title of the FOA to which the application is responding
  • Prior grant application number
  • eRA Commons user ID of the PI or the contact PI

In the event the resubmission (A1) application is not awarded, applicants may submit a new (A0) P01 application with similar science, in accordance with the NIH application submission policy as stated in NIH Guide Notice NOT-OD-14-074. However, in this circumstance, the applicant must re-initiate the process to request NCCIH permission to apply by contacting NCCIH staff. This is required even if the new (A0) P01 application has the same science and budget as an earlier application.

D. Timing

Potential applicants are strongly encouraged to begin informal discussions with NCCIH scientific staff as early as possible in the process of planning their proposed P01 application. Typically, this would be 4 to 6 months prior to the application receipt deadline. Letters of request are reviewed on a rolling basis, so it is to the investigator’s benefit to submit the letter as early in the process as possible, and thus receive a decision as to whether they would be given permission to apply. This would maximize the time available for the investigator to craft the actual application. At a minimum, the letter of request must be received by NCCIH at least 6 weeks prior to application receipt date. Importantly, if the RPA is received on or about the 6-week deadline, a decision regarding approval or denial of the RPA likely will not be communicated until roughly 2 weeks prior to the receipt date deadline for the P01 application. Thus, it is highly advisable that RPA requests be submitted well in advance of the 6-week deadline to give applicants sufficient time to incorporate NCCIH comments into their application should the RPA be approved.

Important dates for the P01 application process are summarized in Table 1. Application receipt dates also can be found on the “Standard Due Dates” website at grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates. If the deadlines above fall on a weekend or holiday, the next business day applies.

For applications to be submitted for the AIDS receipt dates, the deadlines for the pre-submission milestones follow the standard schedule (i.e., the letter of request deadline is 6 weeks prior to submission date and the deadline for completing the staff consultation is 2 months prior to the AIDS receipt date).

Table 1. Important Dates for the P01 Application Process

Discussion With Program StaffSubmit RPAApplication Receipt Date
Before October 25By December 14January 25
Before February 25By April 13

May 25

Before June 25By August 14September 25

E. NCCIH Division of Extramural Research Director

All requests for permission to apply, subject to this policy, should be submitted (by email with the PDF document as an attachment) to the NCCIH Director of the Division of Extramural Research and copied to the relevant Branch Chief:

Emmeline Edwards, Ph.D.
Director, Division of Extramural Research
NCCIH
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Phone: 301-594-7102
Email: emmeline.edwards@nih.gov

Basic and Mechanistic Research Branch
Wen Chen, Ph.D.
Acting Chief, Basic and Mechanistic Research Branch
NCCIH
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
Phone: 301-451-3989
Email: wen.chen@nih.gov

Clinical Research Branch
Wendy Weber, N.D., Ph.D., M.P.H.
Chief, Clinical Research Branch
NCCIH
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
Phone: 301-402-1272
Email: wendy.weber@nih.gov

F. Frequently Asked Questions

Question 1: How are the NCCIH timelines for the letter of request and (resubmission application) letter of intent affected by applications eligible for submission under the NIH Policy on Late Submission of Grant Applications?

Answer 1: NCCIH expects applicants to adhere to the deadlines specified in this policy as they apply to the cycle for the Council to which an application is to be submitted. Given extenuating circumstances, staff members may grant latitude on these deadlines—not to exceed 2 weeks for applications submitted to standard receipt dates or 1 week for applications submitted to expedited receipt dates (e.g., AIDS receipt dates).

Question 2: How are the NCCIH timelines for the letter of request and (resubmission application) letter of intent affected by applications eligible for submission under the NIH Continuous Submission Policy?

Answer 2: Applications that are eligible for submission under the NIH continuous submission policy must still follow the timelines described.

G. References and Resources

Templates

(for inclusion in the required letter of request)

Policies and Guidance