II. Pre-Application Procedures

A. Communication With NCCAM Staff

Early communication between the potential applicant group and an NCCAM program officer is critical for the development of a successful P01 application. These discussions are strongly encouraged to begin a minimum of 5 months before submitting the application and may include the choice of funding mechanism for the proposed science, relevance of the topic to the NCCAM mission, scope and approach of the project and cores, and organization of the application. Information about NCCAM research priorities and program contact information is available on the NCCAM Web site.

B. Permission Process in Order To Submit a P01 Grant Application

NIH requires that all applications (both new and competing renewal) requesting more than $500,000 in direct costs in any year obtain permission from the appropriate institute or center before the application can be accepted for review. Given the large budgetary commitment to a CERC, NCCAM reviews these requests based on their relevance to high-priority research areas established by NCCAM.

A written "request for permission" is due at least 8 weeks prior to the application receipt date. However, NCCAM strongly encourages investigators to submit the request for permission much earlier in the cycle (e.g., 5 months prior to the receipt date); this can significantly aid the PI in the subsequent development of the full application itself. 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 program director who is the point of contact for the application.

The "request for permission to apply" should contain:

1. Overall CERC title; proposed submission date, start date, duration, and timeline
2. Project description (abstract)
3. Summary of the overall center that includes the unifying scientific theme, background, rationale, significance of the application, and overview of the scientific design. A statement should be included on how the synergy and interrelatedness among the projects and cores will move the field forward and how this area addresses the priority research areas identified by NCCAM. If the application is a renewal, the summary should provide specific examples of accomplishments of the projects (5 pages)
4. Specific aims for each individual project and core (1 page each), including:
   
   1. For any proposed human subjects research: estimated sample size and its rationale, estimate of study population availability, as well as general statistical assumptions for the study design and analysis
   2. For any proposed natural product-based research: description of the products (e.g., source/manufacturer, genus, species, strain, and isomers to be used) and if the product would be delivered to human subjects, summary of the current investigational new drug (IND) status and related plans.
5. Biosketches (including other research support) of all the project and core leaders
6. Draft budget
7. For renewals: specific examples of collaboration during the prior award (e.g., how work in one project has catalyzed research progress in other projects and how results, expertise, and resources are shared between projects and cores) and a list of publications that derived from the P01 grant.

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?
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 at least three discrete projects and a core that serves 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.