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 Integrative Health (NCCIH)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.  The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Dietary Supplements (ODS)

Funding Opportunity Title

Center for Natural Product Technology, Methodology, and Productivity Optimization (NP-TEMPO) (U41 Clinical Trial Not Allowed)

Activity Code

U41 Biotechnology Resource Cooperative Agreements

Announcement Type

Reissue of RFA AT-14-006

Related Notices
  • January 23, 2019 - Notice of Pre-Application Webinar for the NIH Consortium for Advancing Research on Botanical and Other Natural Products (CARBON) Program. See Notice NOT-AT-19-020.
  • NOT-AT-19-002
Funding Opportunity Announcement (FOA) Number

RFA-AT-19-003

Companion Funding Opportunity

RFA-OD-19-001, U19 Research Program - Cooperative Agreements; RFA-AT-19-002, U24 Resource-Related Research Projects – Cooperative Agreements

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

 93.213, 93.321

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits applications for research that will improve on and strengthen technology and methodology used in natural products research. The Center for Natural Product Technology, Methodology, and Productivity Optimization (NP-TEMPO), 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 annotation of natural products. 

Key Dates

 

Posted Date

January 22, 2019

Open Date (Earliest Submission Date)

March 29, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

April 29, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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 2019

Advisory Council Review

January 2020

Earliest Start Date

July 1, 2020

Expiration Date

April 30, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. 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

    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 in natural products research have steadily declined over the past two decades.  This shift is often attributed, in part, to persistent technological or methodological challenges that have not been adequately addressed. Lack of progress in this area has led to a lack of progress in translation of promising leads into clinically useful outcomes with potential positive public health impacts. Many of the techniques currently employed for studying complex mixtures of natural products have not taken full advantage of advances in biological, chemical, and computational 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. Doing so will make natural products research a more productive endeavor and allow it to seamlessly integrate with other fields of biomedical research.

    Objectives

    This initiative, Center for Natural Product Technology, Methodology, and Productivity Optimization (NP-TEMPO), is intended to energize the research community to overcome methodological, technological, and computational obstacles to natural products research. A successful NP-TEMPO project is expected to develop and disseminate technologies, methodologies, or 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 NP-TEMPO itself and in collaboration with other investigators possessing diverse expertise and research backgrounds.

    This FOA is being released in conjunction with the NCCIH Natural Products NMR Open Data Exchange (NP-NODE) and the Office for Dietary Supplements (ODS) Botanical Dietary Supplements Research Centers Program. Collectively, the awards under these FOAs constitute the NIH Consortium for Advancing Research on Botanical and Other Natural Products (CARBON) Program. Grantees funded through this NP-TEMPO FOA are expected to collaborate, where appropriate, with the future NP-NODE, the Botanical Dietary Supplement Research Centers, and other NCCIH-, ODS-, and NIH-supported grantees.

    For the purposes of this FOA, natural products include vitamins, minerals, and probiotics as well as small molecules derived from plants, fungi, bacteria, marine organisms, or animals. They may also exist along a spectrum of complexity from crude extracts to purified constituents.

    The NP-TEMPO will consist of three or four Technology Research Projects. Each project will need to address a critical challenge in natural products research. The projects, individually and collectively, should not be a repackaging of existing techniques and methodologies but might include adaptation and optimization of existing tools and technologies for the natural products research community. Projects may also propose an entirely new approach. In either case the projects should push the boundaries of current capabilities.

    Ultimately, the NP-TEMPO should strive to develop innovative technology and methodology that will push the field of natural products forward in a substantive way. The NP-TEMPO, if successful, should significantly accelerate the pace and productivity of natural products research.

    Technology Demonstration Projects

    Development of new natural product research tools is most effective when pursued in the context of challenging problems that drive the technology forward.  Thus, Technology Research 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 Technology Research Projects.  TDPs are research projects not directly funded through the NP-TEMPO but that will collaborate with, utilize and benefit from the Center’s Technology Research Projects.  A TDP should be collaborative in nature, with Center personnel working jointly with investigators from outside the Center. 

    Given the new technologies are under development and will need extensive testing and validation before they can be widely distributed, the TDP will act as stress tests for the new technology to identify its weak points and thus help to improve its reliability and robustness. The selected TDP projects should present substantial technical challenges that are difficult to solve with current approaches.  Collaborations should present the opportunity for an iterative push-pull relationship to develop between Technology Research Projects and the TDPs, advancing both the technology and the natural products projects.  Importantly, the NP-TEMPO must work with TDP collaborators who are receptive to these new approaches and willing to engage in a certain amount of trial and error to make them work optimally.  

    The TDPs served by Technology Research Projects should be broad in scope and involve multiple funded natural product research projects.  The TDP collaborators should have their own independent funding since no subawards from the NP-TEMPO to the TDP are allowed.  The NP-TEMPO is expected to be highly collaborative with, and responsive to, a user community whose members are primarily supported by the NIH; although NIH funding is not a strict requirement for a TDP.  It is expected that turnover in TDPs will occur during the project period. 

    Specific Areas of Research Interest

    This initiative is focused on the development and dissemination of technologies for the chemical and biological investigation and annotation 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:

    • Innovative computational approaches for better characterization of network-level pharmacologic interactions between complex mixtures and complex biological systems
    • Methodologies that can identify active components with reduced reliance on bioactivity-guided fractionation
    • Tools to quickly identify biological targets for natural products
    • Novel approaches for rapid dereplication of active components in complex mixtures
    • Development of high-content phenotypic assays capable of capturing multiple mechanisms of action
    • Novel tools for chemical and biological annotation of complex mixtures that can qualitatively and/or quantitatively establish the presence of multiple active constituents (e.g., additive, synergistic, or antagonistic) in a complex mixture.

    The tools for the chemical and biological characterization of complex natural product mixtures are distinct from tools geared toward the improvement of their isolation, 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 nonresponsive to this FOA and will not be reviewed.

    • Tools that are too limited in their application to a particular structure; a particular target, disease, or condition; a particular natural product source; etc., rather than broadly applicable across chemical and biological targets
    • Projects focused on methodologies to improve production of individual natural products or their derivatives
    • Projects focused on tools to modify natural products for the purpose of improving potency, novelty, etc.
    • Creation of natural product libraries
    • Tools focused on chromatographic fractionation or purification of natural products
    • Synthetic biology tools to identify biosynthetic pathways or increase their expression
    • Development of tools and technologies that do not address existing bottlenecks or challenges.

    See Section VIII. Other Information for award authorities and regulations.

    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. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

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

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    Issuing IC and partner components intend to commit an estimated total of $2,100,000 to fund 2 awards.

    Award Budget

    Application budgets are limited to $700,000 in annual Direct Costs, but should 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 from this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

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

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    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 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.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • o   NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

    All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    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:

    • Descriptive title of proposed activity
    • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
    • Names of other key personnel
    • Participating institution(s)
    • Number and title of this funding opportunity

    The letter of intent should be sent to:

    Martina Schmidt, Ph.D.
    Telephone: 301-594-3456
    Fax: 301-480-2419
    Email: schmidma@mail.nih.gov

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    6

    Administrative Core

    6

    Technology Research Project

    12 per project

    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: required
    • Administrative Core: required
    • Technology Research Projects: required; minimum 3, maximum 4
    Overall Component

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

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

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

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

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

    A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

    Research & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

    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 NP-TEMPO  

    Research Strategy:  The NP-TEMPO program is expected to assume a leadership position within the natural products research community.  Applicants should describe the long-term objectives of the NP-TEMPO including how the proposed technology addresses existing bottlenecks or challenges and its anticipated impact on natural product research.  Strategies for broadly promoting awareness of existing methodology and the sharing of new technologies should be described. 

    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 Technology Research Projects and their relevance to the overall theme and objectives of the program.  This section should include preliminary data that is broadly supportive of the technological approaches proposed

    It is expected that the Technology Research 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 NP-TEMPO are synergistic rather than a collection of independent projects.  Describe howl the overall impact of the NP-TEMPO activities will exceed the sum of the individual components. 

    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.  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 NP-TEMPO.  If the application is a consortium including multiple institutions, similar letters of support from each of the participating institutions must be included.

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

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions. 

    PHS Human Subjects and Clinical Trials Information (Overall)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

    All instructions in the SF424 (R&R) Application Guide must be followed 

    PHS Assignment Request Form (Overall)

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    Administrative Core

    When preparing your application, use Component Type ‘Admin Core.’

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

    SF424 (R&R) Cover (Administrative Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Administrative Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Administrative Core)
     

    Other Attachments: The following attachment is required in the Administrative Core Component.  Applications missing this attachment will not be reviewed.

    Technology Demonstration Project Summary:

    Applicants must include a one to three-page summary, titled "Technology Demonstration Project Summary", that describes their strategy for identifying potential collaborators and how they will go about recruiting and prioritizing Technology Demonstration Project (TDP) collaborations.  This should take into consideration the requirement that the TDPs have their own funding.  Furthermore, turnover in TDPs is expected, so criteria for when it is appropriate to terminate a TDP should also be included.  The summary should also elaborate on how TDPs will be chosen to provide a variety of challenging contexts for the technology they are developing.  In other words, the TDP should not duplicate conditions already tested in the Technology Research Projects.  Applicants should describe how the TDP will accelerate development of the proposed technology.  Applicants should NOT name any potential collaborators in this attachment or elsewhere in their application.

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

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

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

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

    List all performance sites that apply to the specific component.

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

    Research & Related Senior/Key Person Profile (Administrative Core)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Director and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   
    Budget (Administrative Core)

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

    Sufficient funds must be allocated to allow for key personnel to attend the annual meeting of the CARBON Program.

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

    PHS 398 Research Plan (Administrative Core)

    Specific Aims:  State concisely the goals of the Administrative Core  

    Research Strategy:   

    Describe the organizational structure and staff responsibilities of the NP-TEMPO.  Describe how the PD/PI and the proposed Center staff will be organized with respect to the Center components: Technology Research Projects, Technology Demonstration Projects, 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 NP-TEMPO Operating Procedures. 

    The NP-TEMPO must have an External Advisory Committee (EAC).  This group is appointed by the NIH Program Staff in consultation with the PD/PI and advises the PD/PI and NIH 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 NCCIH 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 EAC should meet at least annually and prepare a written report of its recommendations.  This report must be supplied as part of the NP-TEMPO Annual Progress Report.

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

    Appendix:

    Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

    PHS Human Subjects and Clinical Trials Information (Administrative Core )

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

    Technology Research Projects

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

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

    SF424 (R&R) Cover (Technology Research Projects)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Technology Research Projects)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Technology Research 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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Technology Research 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 (Technology Research Projects)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   
    Budget (Technology Research Projects)

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

    Sufficient funds must be allocated to allow for key personnel to attend the annual meeting of the CARBON Program.

    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 (Technology Research Projects)

    Specific Aims:  State concisely the goals of the Technology Research Project  

    Research Strategy:  

    The central focus of the NP-TEMPO is on development of novel technologies and methodologies through the Technology Research Projects. The NP-TEMPO Technology Research Projects must be a dynamically evolving research and development program.  This internal R&D effort serves as the foundation of all other activities.  Each Technology Research Project will include substantial effort related to its development and refinement.  The projects should describe these efforts in detail.  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. 

    The applicant should explicitly state the current bottleneck that is being addressed with the proposed technology in each project.  The applicant should also justify the proposed technology in light of existing options for addressing the identified problem.  The applicant should describe how the new technology will result in new knowledge or capabilities for the natural products researcher.  An element of high risk (and potentially high payoff) may be present in one or more of the projects.  If the project involves a high level of risk this should be justified based on the potential impact.

    Applicants should describe a strategy for establishing the TDPs post-award, but should NOT explicitly name any potential collaborators in their application.  A process for recruiting, selecting, and terminating TDPs should be presented.  Because each Technology Research Project can collaborate with only a limited number of TDP, applicants should include clear criteria for how TDP will be prioritized.  Importantly, the NP-TEMPO should make the establishment of TDPs with the affiliated future Botanical Dietary Supplements Research Centers, NP-NODE and other NCCIH and ODS supported grantees a high priority. No support may be requested in the application for TDP activities conducted outside of the NP-TEMPO.  Support for NP-TEMPO staff conducting TDP-related work should be requested.  Purely technical collaborations focused on advancing some aspect of Technology Research Projects should be included within the relevant Technology Research Projects. 

    Letters of Support: Letters of support from Technology Research Projects should be included here.

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

     Appendix:

    If there are modifications to Appendix instructions, (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-129.html), add the following text:

    ", with the following modifications" 

    Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Technology Research Projects)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed 

    3. Unique Entity Identifier and System for Award Management (SAM)

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. 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.

    7. 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).

    Scored Review Criteria  Overall

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the Center address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous?  If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?   Is successful achievement of the Center's overall Specific Aims likely to significantly change the field of natural products research? To what extent is the proposed collection of technologies applicable across the spectrum of natural products research?  Will existing methodological, technological, and computational obstacles to natural products research be overcome?  Will this have a significant impact on the chemical and biological annotation of natural products?  Does it have the potential to ultimately change the landscape 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 those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  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)? 

    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?  To what extent do the proposed technologies represent a leap forward in capabilities as opposed to a more iterative development?

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

     1) the protection of human subjects from research risks, and

     2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?   

    Does the proposed technology directly address bottlenecks associated with natural products research involving complex mixtures?

    How well are the separate projects organized around a central theme?  How well does the Center address the needs of the natural products research community?  Are the projects synergistic? 

    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 - Technology Research Projects

    Each Technology Research 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? Is the prior research that serves as the key support for the proposed project rigorous? 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? 

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project?  If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 

    Innovation

    Does the application challenge and seek to shift current research 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 Technology Research Projects result in new knowledge or capabilities for end-users in the natural products research field?  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?  Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?  Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented?  If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

     1) the protection of human subjects from research risks, and

     2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?  

    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?

    Additional Review Criteria Overall, Administrative Core, and Research Projects

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

    Review Criteria - Administrative Core

    The Administrative Core will receive a merit descriptor only (e.g. Outstanding, Acceptable, Unacceptable)

    Does the TDP strategy motivate further research and development in the Technology Research Projects? In other words, is a significant push-pull relationship described between the TDPs and related Technology Research Projects?  Does the TDP strategy provide significant, real world, applications of the NP-TEMPO technologies to challenging natural products research problems? Will the TDP strategy provide an adequate research environment to test the methodologies/technologies to be developed in the Technology Research Projects? Is the approach for the TDPs well-reasoned and appropriate?  Are plans for selection, retention and termination of the TDPs well described and appropriate?

    Are the qualifications of the Core Director and other senior key personnel appropriate to lead the U41 and coordinate all U41 activities?  Is (Are) the Core Director(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 Core Director(s) fully established at the applicant institution(s)? Are the scientific and managerial credentials of the Core Director(s) and the credentials of other key professional and technical staff appropriate?

    Are the administrative aspects presented appropriate and adequate?  Is the space set aside for the NP-TEMPO 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 Core Director(s) and institution(s) to the NP-TEMPO appropriate and adequate for a center of national significance?

    Are the plans for the External Advisory Committee appropriate?

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Individuals Across the Lifespan  

    When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    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

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

    Revisions

    Not Applicable.

    Additional Review Considerations Overall, Administrative Core, and Research Projects

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

    Applications from Foreign Organizations

    Not Applicable.

    Select Agent Research

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

    Resource Sharing Plans

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


    Authentication of Key Biological and/or Chemical Resources

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    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), convened by NCCIH 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:

    May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

    Will receive a written critique.

    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 National Advisory Council for Complementary and Integrative Health. The following will be considered in making funding decisions:

    Scientific and technical merit of the proposed project as determined by scientific peer review.

    Availability of funds.

    Relevance of the proposed project to program priorities.  

    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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

    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 terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    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 Part 75. 

    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 NCCIH 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:

    • Determining experimental approaches, designing protocols, proposing project milestones, and conducting the work.
    • Coordination and maintenance of the center activities within his or her institution, with collaborating scientists, and with the NCCIH/ODS Project Scientist and Program Official coordinate activities including the External Advisory Committee meetings (see below).
    • Incorporating relevant improvements and developments in technology over time, as appropriate.
    • Interacting with the natural product community to ensure that the resources emanating from the Center continue to meet the needs of the field.
    • Ensuring that the technology and/or methodology produced or assembled by the resource are made publicly available.
    • If appropriate, developing the training documentation or courses to assist the scientific community in using the resources developed by this project.
    • Establishing and chairing an Internal Steering Committee to coordinate and manage the Center activities.  The recipient will name investigators to serve as members on a Steering Committee and other subcommittees, as appropriate, meeting periodically. 
    • Cooperating in the reporting of the study findings. The recipient will retain custody of and have primary rights to the data and software developed under these awards, subject to the Government rights of access consistent with current HHS, PHS and NIH policies.  The NIH will have access to and may periodically review all data generated under an award. Where warranted by appropriate participation, plans for joint publication with NCCIH/ODS of pooled data and conclusions are to be developed by the Principal Investigator or Steering Committee, as applicable.  NIH policies governing possible co-authorship of publications with NCCIH/ODS staff will apply in all cases.  In general, to warrant co-authorship, NCCIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts.

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

    • Be the contact point for all facets of the scientific interaction with the recipient.  As required for the coordination of activities and to expedite progress, NCCIH/ODS may designate additional staff to provide advice to the recipient on specific scientific and/or analytic issues.  Such staff may include another Project Scientist or Analyst, who will provide direct technical assistance to the recipients to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.
    • Approval of annual milestones and evaluation of level of completion of milestones as reported in annual progress report.
    • An NCCIH Program Official will be named in the award notice who will retain overall programmatic responsibility for the award including normal program stewardship and review of the scientific progress of each of the center projects and the dissemination of the core technologies and assembled resources to the natural products research community. 
    • Interacting with the principal investigator on a regular basis to monitor study progress. Monitoring may include: regular communication with the principal investigator and staff, periodic site visits for discussions with recipient research teams, observation of management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, External Advisory Committee, and related meetings. The NIH retains, as an option, periodic external review of progress.
    • Providing advice on the management and technical performance of the projects.
    • Assisting in promoting the availability of the resources developed during the course of this project to the scientific community at large.
    • Helping to coordinate the work on this project with related projects.  In particular, facilitating interaction between the Center and other NIH grantees that may be suitable collaborators for TDPs.
    • Convene the first meeting of and subsequently participate in the Steering Committee that oversees study conduct. The NCCIH/ODS Project Scientist or designee will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.
    • Will be responsible for establishing an External Advisory Committee (EAC), in consultation with the PD/PI(s), and working with the PD/PI to coordinate regular EAC meetings. The EAC will be composed of the Project Scientist, who will serve as a voting member, and up to five external advisors with appropriate expertise to provide advice relative to the methods and objectives of the NP-TEMPO as well as make recommendations to NCCIH/ODS regarding the continuation to the next stage of implementation of the projects. The EAC will serve as the primary advisory body of the NP-TEMPO, and the Project Scientist will rely on the EAC for objective evaluation of the Program.

    The External Advisory Committee will:

    • Monitor progress of the Technology Research Projects and assess their potential impact on the field of natural products research
    • Establish procedures for recruitment, monitoring, and termination of TDPs during the course of the project
    • Monitor the use of technologies and resources developed in the NP-TEMPO by other investigators
    • Evaluate the effectiveness of the NP-TEMPO PI
    • Identify problems and suggest possible solutions
    • Make recommendations to NCCIH/ODS about whether to continue individual Technology Research Projects throughout the lifecycle of the project
    • The EAC’s evaluations and recommendations, in the form of a written annual report, are to be submitted to the Project Scientist and the NP-TEMPO PI, and will be used by the Project Scientist and the NP-TEMPO 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 NP-TEMPO PI must provide a thorough explanation and rationale to NCCIH/ODS. 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 NP-TEMPO award date.

    Areas of Joint Responsibility include:

    • Evaluating the Center's progress in meeting its goals and the research community’s needs.
    • Ensuring that coordination with related projects happens as needed.
    • Discuss progress in meeting the goals of the Technology Research Projects.
    • Serve as a venue for coordinating the improvement of resources through collectively evaluating new procedures, resources, and technologies.
    • Establish an Internal Steering Committee.  The Steering Committee Chair will not be an NIH staff member. The Steering Committee may add additional members. Other government staff may attend the Steering Committee meetings, if their expertise is required for specific discussions.

    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 NCCIH/ODS Project Scientist or designee. An initial meeting of the Steering Committee will be convened early after award by the NCCIH/ODS Project Scientist or designee. The final structure of the Steering Committee will be established at the first meeting. The NCCIH/ODS Project Scientist or designee will have voting membership on the Steering Committee, and as appropriate, its subcommittees.  The NCCIH/ODS 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 NCCIH 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 Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    A final RPPR, 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. 

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    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 Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

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

    Peer Review Contact(s)

    Martina Schmidt, Ph.D.
    National Center for Complementary and Integrative Health (NCCIH)
    Telephone: 301-594-3456
    Fax: 301-480-2419
    Email: schmidma@mail.nih.gov

    Financial/Grants Management Contact(s)

    Shelley Carow
    National Center for Complementary and Integrative Health (NCCIH)
    Telephone: 301-594-3788
    Email: carows@mail.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 Part 75.    

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