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)
Office of Dietary Supplements (ODS)

Funding Opportunity Title

Center for Advancing Natural Products Innovation and Technology (U41)

Activity Code

U41 Biotechnology Resource Cooperative Agreements

Announcement Type

New

Related Notices

  • March 20, 2014 - See Notice NOT-AT-14-003. Notice of Pre-Application Webinar.

Funding Opportunity Announcement (FOA) Number

RFA-AT-14-006

Companion Funding Opportunity

RFA-OD-14-001, P50 Specialized Center

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) is soliciting applications to establish a national Center for Advancing Natural Product Innovation and Technology (CANPIT).  The goal of this initiative is to improve upon and strengthen technologies and methods used in natural products research.  The CANPIT, supported through the U41 cooperative agreement funding mechanism, is expected to overcome existing research limitations by developing and/or adapting cutting edge, innovative approaches and technologies that will have significant impact on the chemical and biological investigation of natural products.  Importantly, the CANPIT is expected to serve a leadership role; coordinating intellectual scientific discourse and disseminating assembled methodology and best practices to the natural product research community. This FOA is being released in conjunction with the ODS Botanical Dietary Supplement Research Centers Program (see companion FOA, RFA-OD-14-001).  Applicants applying under this CANPIT FOA are encouraged to collaborate with the Botanical Dietary Supplement Research Centers, and other NCCAM, ODS, and NIH supported grantees through CANPIT Technology Demonstration Projects (TDPs).    

Key Dates
Posted Date

December 5, 2013

Open Date (Earliest Submission Date)

May 27, 2014 

Letter of Intent Due Date(s)

May 27, 2014

Application Due Date(s)

June 27, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2014

Advisory Council Review

January 2015

Earliest Start Date

March 2015

Expiration Date

June 28, 2014

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


Background

Natural products have a long and impressive history as sources of medicine and as important biological research tools.  Despite this remarkable track record, pharmaceutical, government and academic investments have steadily declined over the past two decades.  This shift is often attributed, in part, to persistent technological challenges that have not been adequately addressed.  Many of the techniques for studying complex mixtures of natural products have remained largely unchanged for many years and have not taken full advantage of innovative advances in biological and chemical methodology.  To move the field forward, there must be a renewed emphasis on overcoming methodological and technological hurdles that hinder advances in natural products research.  This CANPIT FOA will support efforts to meet this challenge.

This FOA shares many features with, and is modeled in part on, the Biotechnology Resource Center Programs at NIGMS (http://www.nigms.nih.gov/About/Overview/BBCB/BiomedicalTechnology/BiomedicalTechnologyResearchCenters.html) and NIBIB (http://www.nibib.nih.gov/research/featured-programs/biomedical-technology-resource-centers).  Investigators are encouraged to use these Programs as resources in preparing their CANPIT application.

Objectives

This initiative is intended to energize the research community to overcome methodological and technological obstacles facing natural products research.  This FOA also requires applicants to take a leadership role in natural products research.  A successful CANPIT is expected to consolidate, develop and disseminate technologies, methodologies and approaches that will improve upon, and ultimately change the landscape of natural products research.  Such advances can only be achieved through a synergistic interaction between experts in relevant technologies and natural product researchers, both within the CANPIT itself and in collaboration with other leading investigators. 

The CANPIT is also expected to provide intellectual leadership by coordinating workshops, think tanks, and working groups with other natural products experts.  The CANPIT is expected to identify and articulate the needs of the research community and develop and disseminate directories, wikis, review articles, best practices, or other resources to the broader natural products research community.  Through these efforts, the CANPIT is expected to consolidate existing knowledge and technology, combine it with the innovative methodology emerging from the CANPIT, and export these innovative approaches to the community, thereby achieving a broader impact on natural product research than would otherwise be possible.

This CANPIT FOA is being released in parallel with the Botanical Dietary Supplement Research Centers (BDSRC) FOA (RFA-OD-14-001).  The BDSRC initiative shares some objectives with this FOA by supporting the development of improved technologies to increase our understanding of how botanical mixtures impact health and wellness.  This Program is part of a diverse portfolio of projects focused on natural product research supported by NCCAM and ODS.  A list of currently funded NCCAM Centers can be found on our website athttp://nccam.nih.gov/research/centers.  Collectively, these natural products researchers can play a key role in identify challenging technological problems associated with research on complex mixtures and may serve as important collaborators with the CANPIT.   As such, it is expected that the efforts of the CANPIT will be coordinated, in part, with existing ODS and NCCAM projects.  However, the CANPIT is not required to limit itself to collaborating only with NCCAM and ODS funded projects when seeking research partners.

To ensure that the CANPIT continues to meet NCCAM and ODS programmatic needs throughout its funding period, NCCAM will use the U41 cooperative agreement mechanism.  Under this mechanism, program staff will be involved in the CANPIT to help coordinate activities and interactions with the BDSRC and other grantees, and monitor progress to help meet the needs of the natural product research community. 

Specific Areas of Research Interest

This initiative is focused on the consolidation, development and distribution of technologies for the chemical and biological investigation of complex natural products.  Improvements are needed in many areas of natural product research.  Applicants should strive to address as many of these challenges as possible in their applications.  Examples of needed technological advances that would be appropriate for this FOA include, but are not limited to:

The tools for natural product characterization are distinct from tools geared towards the improvement of their expression, yield, potency, etc.  The following topic areas would not be appropriate for this initiative.  Specific research projects proposing development of these technologies will be considered unresponsive to this FOA and will not be reviewed.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

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.

Issuing IC and partner components intend to commit up to $2,000,000, for fiscal year 2015.  Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $750,000 in Direct Costs, but must reflect the actual needs of the proposed project.

Award Project Period

Support may be requested for up to five years.   

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

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.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

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.

The PD/PI must be Director of the Administration and Management component, but does not have to be a Project Leader of one of the awarded Technology Research and Development Projects.  For multiple PD/PI applications, one of the PDs/PIs must direct the Administrative Core.  PDs/PIs are advised that peer reviewers will assess whether there is appropriate commitment of effort to the Center by the PDs/PIs.

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.

Letter of Intent

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:

The letter of intent should be sent to:

D. Craig Hopp, Ph.D.
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Blvd, Suite 401
Bethesda, MD 20892
Telephone: 301-496-5825
Email: hoppdc@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

6

Admin Core (Use for Administration and Management component)

6

Project (Use for each Technology Research & Development project)

12

Coord and Dissemin (Use for the Coordination and Dissemination component)

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 SF424 (R&R) 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.

Other Attachments: The following attachment is required in the Overall Component.

Technology Demonstration Project Summary: Technology Demonstration Projects (TDPs) are research projects not directly funded through the CANPIT but that will collaborate with, utilize and benefit from the Center’s TR&D projects.  Details about the TDPs are provided in the TR&D project sections. 

This section should provide an overview of the TDPs, describing the challenging problems they address and the iterative push-pull relationship between the TR&D projects and the TDPs.  Utilization of the Center resources and collaborations should be described in the context of the Center as a whole.  The overall process for selection, retention and termination of TDPs should be described.

A table listing all the TDPs should be attached. Each entry in the table should include:

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.

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)

Specific Aims:  Describe the long range objectives of the proposed CANPIT.  

Research Strategy:  The CANPIT is expected to assume a leadership position within the natural products research community.  Applicants should describe the long term objectives of the CANPIT including how the proposed technology addresses existing bottlenecks or challenges and its anticipated impact on natural product research.  Plans for coordinating and integrating input from the natural product research community should be broadly outlined.  Strategies for promoting awareness of existing methodology and sharing new technologies and methods as broadly as possible should be summarized. 

This section should describe the broad objectives of the Center and the potential impact on the natural product research field.  Describe the relationship between the individual TR&D projects and their relevance to the overall theme and objectives of the program.  The application should provide an overview of the Center’s components (Technology Research and Development projects, Technology Demonstration Projects, Coordination and Dissemination; see below) and a conceptual framework for their integration.  This section should include preliminary data that is broadly supportive of the technological approaches proposed. 

It is expected that the TR&D projects will be related to each other and that the description of these projects will show synergy among them.  Applicants should elaborate on how the proposed activities of the CANPIT are synergistic rather than a collection of independent projects.  How will the overall impact of the CANPIT activities exceed the sum of the individual components?  Describe the complementary nature of the TR&D projects.  

Letters of Support:  Attach letters of support relevant to the Center as a whole (e.g., letters of institutional support).  Letters of support from other key personnel should be attached in the research plans of the relevant application component.  Letters of support from collaborators related to Technology Demonstration Projects should be included with the description of those projects.  A letter of institutional commitment from the Dean or another official of similar rank must be included.  Letters of institutional support should demonstrate the breadth and depth of commitment to the CANPIT.  If the application is a consortium including multiple institutions, similar letters of support from each of the participating institutions must be included.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a leadership plan must be attached.  A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team should be described, and should include communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts.  The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other contributors.  If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan.  In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

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

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.   

Administration and Management

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 (Administration and Management)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administration and Management)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administration and Management)

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) (Administration and Management)

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 (Administration and Management)

Budget (Administration and Management)

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

Travel:  Funds should be requested as consultant costs to support the travel expenses of the External Advisory Committee (EAC) members to attend the annual onsite EAC meeting.  The funds for the EAC meeting will be restricted for this purpose and may not be re-budgeted without prior approval by Program Staff.  Additionally, there is an annual meeting of the affiliated Botanical Dietary Supplement Research Centers.  It is expected that the PD/PI and at least one other Project Leader or Senior personnel attend this meeting.  Funds to support travel to this meeting should be requested in the 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          (Administration and Management)

Specific Aims:  State concisely the goals of this component.    

Research Strategy:   Describe the organizational structure and staff responsibilities of the CANPIT.  Describe how the PD/PI and the proposed Center staff will be organized with respect to the Center components: Technology R&D Projects, Technology Demonstration Projects, Coordination and Dissemination, and general Center administration.  Describe the scientific and technical expertise of the staff that will operate, maintain, and develop the Center capabilities specifying their distribution of effort across their areas of responsibility.  Describe CANPIT Operating Procedures.  Describe criteria and methods for prioritizing and selecting Technology Demonstration Projects (TDPs).

The CANPIT must have an External Advisory Committee (EAC).  This group is appointed by the PD/PI in consultation with Program Staff and advises the PD/PI on future directions for the Center and in setting priorities for allocation of Center facilities.  Please refer to the Cooperative Agreement Terms and Conditions of Award section for details regarding establishment of the EAC with NCCAM and ODS staff involvement.  Potential EAC members should not be contacted or appointed prior to submission and should not be named in the application.  However, the scientific disciplines of anticipated committee members should be described.  The EAC members and the chair should be from outside the host institution.  The committee chair should be knowledgeable about the Center's technology and the science it serves.  Other committee membership should be balanced among scientists knowledgeable about the Center’s technology, experts in its application to natural product research problems and users of the technology.  The committee's role in advising on addition, termination and management of TDPs for the CANPIT should be presented.  The EAC should meet at least annually and prepare a written report of its recommendations.  This report must be supplied as part of the CANPIT Annual Progress Report.

Letters of Support: Do not include letters of support here.  Letters of support from TDP collaborators and institutions should be included with the associated TR&D Project component.

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.

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.   

Planned Enrollment Report  (Administration and Management)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Administration and Management)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Technology Research & Development (TR&D) Projects

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

A separate TR&D Project Component should be prepared for each TR&D project.

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

SF424 (R&R) Cover (TR&D)

Complete only the following fields:

PHS 398 Cover Page Supplement (TR&D Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (TR&D Projects)

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.

Other Attachments: The following attachment is required in the TR&D Project Component.

Technology Demonstration Projects Description: A one page summary describing each TDP should be included as an attachment to the TR&D project with which it is affiliated.  Since a TDP may drive more than one TR&D it is possible that a TDP summary may be attached to more than one TR&D project.  Applications should have at least one TDP for each TR&D project.  No more than ten TDPs may be proposed for a CANPIT.  Each TDP will be evaluated on the basis of how it advances and stimulates CANPIT technological development.  It is expected that all of the TDPs will have been peer reviewed and externally funded. 

The description of each TDP should begin with the following header information:

(1) Collaborating investigator’s name

(2) The institution of the collaborating investigator

(3) Description of the external project including

Development of new natural product research tools is most effective when pursued in the context of challenging problems that drive the technology forward.  TR&D projects are most effective when they respond to, and are integrated with, the needs of the natural products community.  To encourage synergistic interaction, Technology Demonstration Projects (TDPs) will serve as test-beds for TR&D projects.  A TDP should be collaborative in nature, with Center personnel working jointly with investigators from outside the Center.  The selected natural product research projects should present substantial technical challenges that are difficult to solve with current approaches.  Projects should present the opportunity for an iterative push-pull relationship to develop between TR&D and the TDPs, advancing both the technology and the natural products projects.  The relationship between TR&D projects and each TDP must be clearly defined.

The TDPs served by TR&D projects should be broad in scope and involve multiple funded natural product research projects.  The CANPIT is expected to be highly collaborative with, and responsive to, a user community whose members are primarily supported by the NIH.  Importantly, the CANPIT should make the establishment of TDPs with the affiliated Botanical Dietary Supplement Research Centers and other NCCAM and ODS supported grantees a high priority.  The CANPIT may also propose partnerships with other funded grantees working in this area as well. 

No support may be requested in the application for TDP activities conducted outside of the CANPIT.  Support for CANPIT staff conducting TDP-related work should be requested.  Purely technical collaborations focused on advancing some aspect of TR&D should be included within the relevant TR&D project.

It is expected that turnover in TDPs will occur during the project period.  A process for recruiting, selecting, and terminating TDPs should be presented.

Project /Performance Site Location(s) (TR&D Projects)

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 (TR&D Projects)

Budget (TR&D Projects)

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

Personnel: The budget should include a detailed justification for key personnel under this TR&D component. The person months for each member of the CANPIT staff related to this TR&D should be included here. Support for Center staff conducting TDP related work should be requested under this TR&D component.  Support for graduate students and postdoctoral fellows can be requested only if they are active participants in TR&D research Projects.  It is possible to have overlapped personnel under different components, as long as their total efforts do not exceed 100% under the entire CANPIT.

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          (TR&D Projects)

Specific Aims:   State concisely the goals of the TR&D project. 

Research Strategy: A major focus of the CANPIT is on the Technology Research and Development (TR&D) projects. The CANPIT TR&D projects must be a dynamically evolving research and development program in its own right.  The proposed projects should be at the cutting edge of a specified technological field, with a goal of increasing its utility in natural products research.

Each TR&D project must be presented in detail.   The Research Strategy should address the background and rationale for the project, its significance, specific aims, and methods. 

The application should describe how each project supports of the overall goals of the CANPIT.  An element of high risk (and potentially high payoff) may be present in one or more of the TR&D projects.  Investigators should present alternative approaches to solving technological problems in the event that their main conceptual thrust should prove unattainable.

Letters of Support: Letters of support from TR&D and TDP project collaborators and their institutions should be included here.

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.

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.   

Planned Enrollment Report  (TR&D Projects)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (TR&D Projects)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Coordination and Dissemination Component

When preparing your application in ASSIST, use Component Type ‘Coord and Dissemin’

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

SF424 (R&R) Cover (Coordination and Dissemination)

Complete only the following fields:

PHS 398 Cover Page Supplement (Coordination and Dissemination)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Coordination and Dissemination)

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) (Coordination and Dissemination)

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 (Coordination and Dissemination)

Budget (Coordination and Dissemination)

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          (Coordination and Dissemination)

Specific Aims:  State concisely the goals of the Coordination and Dissemination Plan. 

Research Strategy:  The CANPIT is envisioned to be a national leader in natural products research based on the critical mass of expertise gathered under the TR&D projects and associated partnerships and collaborations under the TDPs.  As such, the CANPIT should actively seek opportunities to leverage its leadership position by coordinating and integrating input from the natural product research community.  The CANPIT should strive to develop visible and readily accessible resources to ensure natural products researchers are using the most appropriate methods and approaches, and that they can readily locate public sector developers of cutting edge methods and technologies.  These activities may include, but are not limited to, the development of resource directories, wikis, review articles, best practices, or other products that address the needs of the broader natural products research community.  The CANPIT will also provide training and consultation to other researchers and aggressively disseminate knowledge gained and technology developed as a result of CANPIT activities. 

Coordination

The CANPIT should describe plans to work collaboratively with other experts in both technology development and natural products research and how it will establish best practices for natural products research.  This may be accomplished by organizing workshops, conferences, think tanks, etc. to better articulate the needs of the natural products community.  As part of this coordination, CANPIT investigators are expected to attend the annual meeting of the Botanical Dietary Supplement Research Centers.  Applicants should budget funds for these various coordination activities.  These efforts should lead to increased understanding of what needs are being met by current approaches and where challenges still exist that will require development of new technologies.

Furthermore, the CANPIT should describe the process by which they will consolidate this information and transform it into a readily accessible and searchable knowledge base for the research community.  This should include a description of the methodology to establish best practices for conducting high quality natural products research capable of meeting NIH or other federal funding standards.  Best practices may include (but are not limited to) optimal methods for:

Finally, the CANPIT application should describe a plan to develop algorithms or similar decision trees and flow charts to guide the natural products community on how these best practices, in combination with the technologies developed by the CANPIT, can be assembled into a methodological scaffold to tackle common challenges.  This scaffold may evolve over time based on new developments in the field.  This resource should also provide information on possible collaborators to contact for specific research needs. 

Dissemination

A fundamental motivation for establishing the CANPIT program is to build on the best of current methodology and augment it with development, where needed, of cutting edge technology to break through barriers in natural product research.  The activities of a CANPIT need to meet this objective by promoting awareness of existing methodology and sharing new technologies and methods as broadly as possible.

Dissemination activities should have three overall objectives:  1) publicize the availability and utility of the resources developed through the coordination activities; 2) inform the scientific community about the technical capabilities and accomplishments of the CANPIT; 3) promote and enable the broader use of these technologies.  A variety of approaches can be proposed to meet these goals.  These approaches could include, but are not limited to, hands on or web-based training and tutorials, publishing articles, books, patents, newsletters, annual reports, or special issues of technical journals; issuing press releases; presenting research results at meetings; conducting workshops and conferences; distributing software products; transferring technologies to other laboratories directly; and licensing technologies to industry.

The technologies, methods, and software developed in the CANPIT are expected to be sophisticated and conceptually novel.  Training generally is necessary to facilitate use by scientists outside the CANPIT.  Furthermore, actively engaging the research community will allow for more rapid and efficient adoption of the new tools than simply through publication in appropriate journals.  Training, therefore, should be planned for and provided by the CANPIT.  Hence, sufficient resources must be allocated for training both specialists and non-specialists in order to make the best possible use of new tools.  Plans for training should be presented in the application, but no specific methods or activities are prescribed.  The choice of approaches should be informed by the special constraints and opportunities presented by the circumstances of the CANPIT. 

A robust web presence is required for the CANPIT.  Support from NCCAM and ODS should be acknowledged on that web site.  The web site should provide information about:

Letters of Support: Include here letters of support from key personnel and institutions involved in this component.  

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.

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.   

Planned Enrollment Report  (Coordination and Dissemination)

Not Applicable 

PHS 398 Cumulative Inclusion Enrollment Report (Coordination and Dissemination)

Not Applicable

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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed. 

In order to expedite review, applicants are requested to notify the NCCAM Referral Office by email at birkled@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 CANPIT 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.

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?  Is successful achievement of the Center's overall Specific Aims likely to significantly change the field of natural products research? 

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?  Have the Center PD(s)/PI(s) demonstrated the ability to effectively and productively manage a large, multi-component, transdisciplinary research project in the proposed research area(s)?  Does the applicant demonstrate a willingness to take on a leadership role in the natural products research community?

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?  Does the Center show evidence of new technology development or innovative applications of existing methodology to address long standing natural products research challenges?

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 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 children, justified in terms of the scientific goals and research strategy proposed?  

Does the applicant demonstrate a commitment to ongoing interaction with the natural products research community?  Are their efforts likely to result in utilization of the assembled resources and technologies?  Is there synergy between the TR&D projects and the technology demonstration projects?

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?  Are the application and investigator track records indicative of the establishment of a strong collaborative environment? 

Scored Review Criteria for TR&D Projects

Each TR&D project will receive a separate overall impact score.

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.

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, or technologies that drive this field?  Is the technology dynamically evolving, state-of-the-art, an important area for research and development in its own right, and likely to address existing bottlenecks or challenges in natural product research?  Does the proposed technology have the potential to significantly change the field of natural products research?  Is there synergy between the TR&D project and the associated TDPs in advancing the technology?  Do the TDPs motivate further research and development in the TR&D Projects, in other words, is there a significant push-pull relationship between the TDPs and related TR&Ds?  Do the TDPs provide significant, real world, applications of the CANPIT technologies to challenging natural products research problems?  

Investigator(s)

Are the PD(s)/PI(s), collaborators, 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 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 the TDPs include an appropriate number of Collaborators from outside the applicant institution?

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?  Will the TR&D result in new knowledge or capabilities for end-users?  How is this project unique?  Is the technology already broadly available?   

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?  Is the approach for the TDPs well-reasoned and appropriate?  Are there plans for transition, retention and selections of the TDPs?

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?   Are the resources for the TDPs available and used appropriately?

Coordination and Dissemination Review Criteria

The Coordination and Dissemination component is scored as a whole regardless of the number of activities subsumed within the component. 

Coordination:  Does the applicant indicate awareness of the field of natural products research such that appropriate dialogue can be established?  Do the coordination activities described allow for sufficient input regarding the needs of the natural products research community?  Is there a direct and meaningful interaction between CANPIT personnel and the research community?

Best Practices:  Are plans to establish best practices for natural products research adequately described?  Have appropriate numbers of best practices been planned to provide outside investigators with a sufficient menu of options necessary to tackle most common natural product research issues?  Has the applicant sufficiently described plans to create a methodological scaffold which will guide potential investigators on how to combine different methodologies for various common challenges associated with the chemical and biological characterization of natural product mixtures? 

Dissemination:   Will their web presence and dissemination plan create sufficient awareness of the assembled resources?  Are efforts described to make both non-expert and expert communities aware of the new technology?  Are plans to provide training opportunities appropriate?  Are sufficient resources allocated for training, so that non-specialists can make the best possible use of the new technologies?  For CANPITs that are developing software, is the software portable when appropriate, well-documented, user-friendly, and readily available to the user community?

Administration Review Criteria

The Administration and Management component will receive a merit descriptor only (i.e., Outstanding, Acceptable, Unacceptable).

Are the qualifications of the Center PD(s)/PI(s) and other senior key personnel appropriate to lead the U41 and coordinate all U41 activities?  Is (Are) the Center PD(s)/PI(s) an established researcher(s) with the ability to ensure quality control and the experience to effectively administer and integrate all components of the program?  Is (Are) the Center PD(s)/PI(s) fully established at the applicant institution(s)?

Are the administrative aspects presented appropriate and adequate?  Is the space set aside for the CANPIT and the laboratory facilities appropriate and adequate?  Are instruments in place and operational, and are staff members currently on site?

Is the commitment of the PD(s)/PI(s) and institution(s) to the CANPIT appropriate and adequate for a center of national significance?  

Are the scientific and managerial credentials of the PD(s)/PI(s) and the credentials of other key professional and technical staff appropriate?

Are the plans for the External Advisory Committee appropriate?

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.

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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 children 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.

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

Not applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

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.

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:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 submitted in response to this FOA. 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement U41, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NCCAM purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

NCCAM staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The EAC will:

The EAC’s evaluations and recommendations, in the form of a written annual report, are to be submitted to the Project Scientist and the CANPIT PI, and will be used by the Project Scientist and the CANPIT PI to guide and direct the program. Subcommittees with additional ad hoc advisors may be established by the EAC as necessary in order to meet its planning, priority setting and evaluation responsibilities. Awardees generally will be expected to accept and implement the recommendations of the EAC; in those situations where implementation of the recommendations is not feasible, the CANPIT PI must provide a thorough explanation and rationale to NCCAM. The first EAC meeting will be convened by the Awardee within three months of the award date. The EAC will then meet annually three months before the anniversary of the CANPIT award date.

Areas of Joint Responsibility include:

The Steering Committee will be composed of the PD/PI and other key personnel as deemed necessary, such as the study biostatistician and project PIs, and the NCCAM Project Scientist or designee. An initial meeting of the Steering Committee will be convened early after award by the NCCAM Project Scientist or designee. The final structure of the Steering Committee will be established at the first meeting. The NCCAM Project Scientist or designee will have voting membership on the Steering Committee, and as appropriate, its subcommittees.  The NCCAM Project Scientist will serve as an “ex officio” member of the Steering Committee.  Such a committee usually will meet at least twice yearly

The Steering Committee has primary responsibility to design research activities, establish priorities, establish and maintain quality control among recipients, review progress, coordinate and standardize data management, and cooperate on the publication of results. Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NCCAM Program Officer, and will provide periodic supplementary reports upon request.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Scientific/Research Contact(s)

D. Craig Hopp, Ph.D.
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-496-5825
Email: hoppdc@mail.nih.gov

Barbara C. Sorkin, Ph.D.
Office of Dietary Supplements (ODS)
Telephone: 301-435-3605
Email: sorkinb@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

George Tucker, MBA
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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