Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Dietary Supplements (ODS)
National Center for Complementary and Alternative Medicine (NCCAM)

Funding Opportunity Title

Botanical Dietary Supplement Research Centers (BDSRC) (P50)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of RFA-OD-09-001

Related Notices

  • March 20, 2014 - See Notice NOT-AT-14-003. Notice of Pre-Application Webinar.
  • January 14, 2014 - See Notice NOT-OD-14-040. Notice of Pre-Application Webinar.

Funding Opportunity Announcement (FOA) Number

RFA-OD-14-001

Companion Funding Opportunity

RFA-AT-14-006, U41 Biotechnology Resource Cooperative Agreements

Number of Applications

Only one application per institution is allowed, as defined in 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) invites applications to support research centers to develop and apply cutting-edge, transdisciplinary approaches to the study of botanicals with relevance to human health, that are found as ingredients in dietary supplements. These centers are expected to synergistically integrate a range of relevant disciplines (e.g., phytochemistry, botany, and expertise utilizing models ranging from in silico through in vitro to in vivo) to conduct innovative research to elucidate the interactions between complex botanical products and human biology. The long-term goal of this program is to support development of the preclinical data required for optimal design of rigorous, definitive clinical research on complex botanical products. Given the extensive resources required for clinical research it is critical that clinical trials of botanicals be supported by solid and extensive relevant preclinical data, especially with respect to mechanisms of action, optimal formulations and dosing, for example. Therefore the focus of these Centers will be on basic and preclinical research. The focus of this FOA is on research on the mechanisms of action of botanicals traditionally used for health maintenance, or on botanicals with strong evidence of promise for improving objective, quantitative measures of organism resilience. Use of relevant vertebrate and invertebrate models is strongly encouraged. A strictly limited number of human subjects research aims, designed to interrogate, e.g., in vivo mechanism(s) of action, safety, pharmacokinetics, or bases of individual differences in metabolism or response, may be included.

Key Dates
Posted Date

December 5, 2013

Open Date (Earliest Submission Date)

May 6, 2014

Letter of Intent Due Date(s)

April 6, 2014

Application Due Date(s)

June 6, 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

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.

Scientific Merit Review

September-October 2014

Advisory Council Review

January 2015

Earliest Start Date

July, 2015

Expiration Date

June 7, 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

Botanicals are used worldwide to promote health; the World Health Organization estimates that ~80% of the world population relies on traditional medicines prepared from natural products, while 25% of all pharmaceuticals prescribed today are derived from plant compounds. Botanical dietary supplements are also commonly used in the U.S. for health promotion and wellness (Barnes, PM et al., National Health Statistics Reports, #12, 2008). Despite their prevalent use, the safety, efficacy, and mechanism(s) of action of many widely used botanicals have not been rigorously evaluated. 

The prevalence of use of botanically-derived natural products may have a rational basis in the common evolutionary roots of the plant and animal kingdoms. The probability that a plant-derived small molecule will interact in a biologically relevant way with animal receptors is greater than the probability of interaction with a randomly synthesized compound. Similar molecules often serve similar functions in plants and animals. For example, zeaxanthin and lutein play protective roles in both plants and animals, while glutamate receptor-like ion channels in plants, like animal glutamate receptors, play critical roles in intercellular signaling.

Botanical products of interest in the context of this FOA will usually have a history of human use that may be leveraged to generate initial hypotheses regarding clinically relevant questions and approaches to optimizing activity (e.g., choice of plant part and preparation). Nonetheless, given the magnitude of the resources required to optimally design and rigorously conduct definitive, clearly interpretable clinical trials of botanical products, more efficient approaches are needed to advance this research. Collaborative, transdisciplinary efforts including a wide range of relevant expertise (from pharmacognosy through pharmacology and multiple biomedical disciplines to cutting-edge analytical, statistical and systems biology or modeling approaches) will be required.

The Office of Dietary Supplements (ODS) and the National Center for Complementary and Alternative Medicine (NCCAM) convened an Expert Panel in April, 2013, to provide advice on approaches to strengthen our ongoing investment in research on botanicals as they relate to human health.

The Panel noted that botanicals as test materials present notable research challenges; while many of these challenges are common to much of biomedical research, an additional layer of complexity is added by the inherently variable, multi-component composition of even a well-defined plant species. Botanicals and their associated endophytes offer extraordinary repositories of diverse metabolites. The active constituent(s) relevant to a given outcome may not be known. In addition, the literature documents biologically relevant interactions between compounds present in complex botanical preparations. These issues complicate all aspects of botanical research. This FOA emphasizes research approaches to address these challenges by developing or applying state-of-the-art approaches to increase the efficiency of research on complex botanicals, or to enhance the potential of such research for clinical translation. 

The Expert Panel emphasized the importance of increased focus on assessing the capacity of botanical dietary supplements to promote resilience and general health. This is consistent with survey data indicating that the majority of U.S. dietary supplement users take supplements for health maintenance and/or prevention, as well as with traditional medical systems' frequent use of plant products as "tonics" or to "restore balance" to the body. To advance research consistent with the prevalent and traditional uses of botanicals, this FOA emphasizes increased focus on the potential of botanicals to improve quantitative, objective outcomes relevant to health and/or resilience. For the purposes of this FOA, resilience is defined as capacity to withstand and successfully adapt to change, disturbance, stress, etc., or to recover efficiently from disturbance, challenge, illness, etc. Examples of relevant outcomes of interest are described below.

Investigators who are considering pursuing a transdisciplinary approach to research on complex botanical extracts as they relate to human health maintenance and/or resilience through an application to this FOA should contact the relevant NIH staff (Section VII. Agency Contacts) early in the process of conceptualizing the project to discuss a potential application. The discussion could include the choice of funding mechanism, relevance of the topic to the research objectives described below, and the scope and approach of the project.

Further information on the ODS-NCCAM Botanical Dietary Supplements Research Centers Program is available on the ODS website.

Research Objectives

This FOA seeks to enhance progress in the understanding of complex botanical preparations used for human health by supporting the development, or deployment from other fields, of cutting-edge techniques or approaches that will accelerate progress in botanical research, including contributing to the ability to rapidly assess the identity and potential of a botanical product for specific health-related bioactivities or for within or inter-product interactions. The renewed Botanical Dietary Supplements Research Centers Program is expected to significantly advance human or other animal health-related botanical research through multi-component, transdisciplinary Centers that bring together projects with the potential to contribute to one or more of the following objectives:

Preclinical projects focused on botanicals with a substantial history of human use, especially those used for health maintenance or improving resilience, are strongly encouraged, especially where focused on objective, quantitative outcomes with clear relevance to human health or resilience. Appropriate and translationally meaningful use of in silico, in vitro, and preclinical in vivo models, including invertebrate models, is strongly encouraged. At least one third of the Research Project specific aims should be focused on botanicals as they relate to resilience or health maintenance. These specific aims may be distributed among the proposed Research Projects as the investigators believe best suits the proposed research.

We anticipate that conduct of this research will include and entail:

Structure of the Botanical Dietary Supplements Research Centers

Each proposed Center must be structured around a central theme to facilitate synergy between the proposed Projects and Cores. For example, the unifying theme for a Center might be an experimental approach, a biological process, or a group of products related by chemistry or usage.

Each Center must include at least 3, and not more than 4 active Research Projects throughout the project period.

Consistent with the focus of this FOA, at least one Research Core in each proposed Center must provide strong expertise relevant to botanical research or a closely related discipline. Each Research Core of each Botanical Research Center (including the botanical Research Core) is expected to contribute to advancing the power of relevant methods and approaches, as well as to the success of the Research Projects.

Each Center must include an Administrative Core that includes coordination of all Center components, as well as coordination to support training, career development, and to solicit, review and support pilot projects (please see the Administrative Core instructions for detailed information on Administrative Core requirements) and a regularly updated Botanical Dietary Supplements Research Center (BDSRC) website.

BDSRC investigator interactions with the NCCAM/ODS Center(s) for Advancing Natural Products Innovation and Technology to be awarded at approximately the same time as the BDSRC, are expected to include, where appropriate and productive, collaborative demonstration projects and participation in meetings, including, but not limited, to the annual meetings of the BDSRC and the CANPIT investigators.

Purview of the FOA

Focus on health and resilience

This FOA requires that at least one third of the specific aims of each proposed Center focus on objective, quantitative outcome measures a) for which relevance to resilience or improved health outcomes is well documented and b) that are validated for the context in which they will be used, or for which there is strong evidence of validity for the proposed use. Such outcomes might include (but are not limited to) gut microbiome diversity,  HbA1c levels, response to vaccine or viral challenge, time to return to initial or normal/healthy levels of inflammatory cytokines or blood glucose after a perturbation, or measures of fatigability. Investigators proposing human subjects research may find other measures of potential interest in the NIH Toolbox.

Appropriate and translationally meaningful use of in silico, in vitro and preclinical in vivo models, including invertebrate models, is strongly encouraged. Resilience or health maintenance-focused specific aims may be distributed among the proposed Research Projects as the investigators believe best suits the proposed research.

Botanicals of interest

Terrestrial plants or macroscopic fungi (and products derived from them) are included within the purview of this FOA. Projects may focus on isolated bioactive plant constituents other than essential nutrients where required for elucidation of mechanisms of action or other experiments that are within scope of this FOA. Applications to conduct research on purified entities found in, or synthetic compounds derived from botanical sources will be considered only where such research is necessary to elucidate the mechanisms of action or activities of the complex botanical. This FOA supports research on traditional herbal medicines as well as on foods of plant origin that are proposed to contain bioactivities beyond basic nutrition. Applications focused on methods to improve large scale production of individual natural products or their derivatives, or on tools to modify natural products for the purpose of improving potency, will be considered unresponsive and will not be reviewed.

Excluded Research Areas

Projects proposing any of the following research will be considered unresponsive and will not be reviewed:

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
Renewal

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 on NIH appropriations and the submission of a sufficient number of meritorious applications. ODS and NCCAM intend to commit an estimated total of not more than $10 million per year in total costs to support up to five awards.

Award Budget

Application budgets may not exceed $1.25 million in direct costs but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 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 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 a Project Leader of one of the awarded Research Projects and Director of the Administrative Core. For multi-PD/PI applications each of the PDs/PIs must be a Project Leader for one of the awarded Research Projects or for one of the proposed Research Cores, and 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 PD/PI(s). Peer reviewers will expect the PD(s)/PI(s) to have demonstrable track records of relevant publications in the peer-reviewed literature and ability to manage a large, multi-component Research Projects.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. .

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:

Barbara C. Sorkin, Ph.D.
Director, Botanical Research Centers Program
Office of Dietary Supplements, NIH
6100 Executive Blvd., Room 3B01, MSC 7517
Bethesda, MD  20892-7517
Telephone: 301-435-3605
Fax: 301-480-1845
Email: sorkinb@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core

12

Core

6

Project

12


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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the 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.

Facilities and Other Resources: Describe the institutional commitment by each participating institution.

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 specific aims of the Center as a whole.

Research Strategy: Describe the long term goals, as well as the specific aims of the Center. Clearly explain in this section or in the appropriate Research Project or Research Core sections how the proposed Center will integrate chemical analysis of complex botanical products with human health-relevant biological outcomes. The outcomes may derive from in silico, in vitro, preclinical in vivo or human subjects research and should have high potential to advance the elucidation of active components, their mechanisms of action, and/or their contribution to the overall activity. Explain the synergy of the components of the Center, i.e., explain how the interactions of the proposed research projects and cores will produce results that will advance understanding further than could be achieved by the individual Research Projects working separately. The presence of Research and Administrative Cores in a Center does not, in and of itself, constitute or guarantee synergy.

Describe prior productive collaborations of the research team(s). Describe the track records of the teams and investigators that provide evidence of the requisite expertise and ability to achieve the specific aims, as well as of a strong collaborative environment for the proposed Center.

Provide a timeline with milestones that can be used to assess progress of the Center as a whole, as well as of the individual research projects and cores, including the administrative core. The timeline should indicate how the Center specific aims will be achieved within the timeframe of the award.

Include a core utilization table, projecting how the research cores will be utilized by the Research Projects, and indicating at least one research area that might be appropriate for collaboration with the Center for Advancing Natural Product Technology and Innovation (RFA AT-14-006)

For renewal applications only, include a progress report that summarizes the aims and accomplishments of the Center as a whole during the prior funding period. Summarize the overall theme and goals of the existing Center, and explain and justify any changes in direction, and in key personnel. See the SF424 instructions for details about what to include in the progress report. If a project from the prior funding period is being discontinued, explain in the overall progress report.

Experimental details about progress relevant to specific Research Projects and/or cores that are proposed to continue should be provided in the corresponding component of the application.

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

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

Letters of Support: Attach letters of support relevant to the center as a whole (e.g., letters of institutional support).  Letters of support relevant to specific projects or cores should be attached in the relevant Project or Core research plans. A letter of institutional commitment from the Dean or another official of similar rank must be included. 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Administrative Core

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

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

Project Narrative:  Do not complete.

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

List all performance sites that apply to the specific component.

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

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

Budget (Administrative Core)

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

The Administrative Core must include funds for travel of the PD/PI(s) and other Senior/Key Center personnel to the Botanical Dietary Supplements Research Centers annual meeting. The annual meeting may be held in conjunction with a major national or international botanical or pharmacognosy conference, or hosted by one of the BDSRC or NIH.

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: Describe the Specific Aims for the Administrative Core.

Research Strategy: The organization of the Administrative Core should encompass a support structure sufficient to establish research milestones and a timeline for achieving those milestones; coordinate and integrate Center activities both within the Center and with other botanical or natural products research efforts; develop a plan for regular evaluation of scientific progress and approach, including appropriate research prioritization, problem and/or conflict resolution, and effective sharing of relevant BDSRC resources including data; form and coordinate interactions with the External Advisory Committee and the Internal Steering Committee; oversee training and career development efforts (see below); and work with the applicant institution to enhance the visibility and effectiveness of the center as a focus for botanical research. 

The Administrative Core may contain limited funds for program enrichment activities such as seminars and research workshops.  Funds from the award cannot be allocated for website development or maintenance, newsletters, consumer information or outreach activities.

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

While the final administrative structure of the Center will be left to the discretion of the Center PD(s)/PI(s), experience demonstrates that effective development of a Center program requires interaction among the director, Research Project and Core leads, advisory groups, appropriate institutional administrative personnel, and NIH program staff. The Center PD(s)/PI(s) may include a Project Manager/Specialist in the Administrative Core.

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

EAC members and the committee chair will be appointed by the Center Director in consultation with NIH Program Staff; members may serve on a rotating basis. It is strongly recommended that EAC members be senior scientists with relevant expertise who are not current or recent faculty at the awardee institution or other participating institutions and are not recent trainees of the PD(s)/PI(s) or Project or Research Core leaders. The PD(s)/PI(s) will serve on the EAC in an ex-officio capacity only. The EAC should consist of three to five members in addition to the Center Director(s). EAC members cannot participate directly in the research of the Center.  If an EAC member becomes directly involved in the research of the Center, the resulting committee vacancy must be reported to NIH program staff and a replacement sought in a timely manner.  Applicants submitting new applications should not identify potential EAC members in their applications. Applicants submitting renewal applications should identify those who have served on the EAC for the current award. While description of EAC activities should be included in the application, potential members of the committee should NOT be contacted, named, or selected until an award has been made.  This stipulation will allow a wider pool of potential reviewers of the applications. In addition to specifying the type of expertise needed, the applicant should also describe the process by which EAC members will be selected. The EAC should be established within three months of the start of the first budget period and meet once before the end of that period. Thereafter, the EAC shall meet at least once a year. Minutes of all (i.e., scheduled and ad hoc) EAC meetings must be kept. Minutes of all EAC meetings shall be sent to NIH staff within 30 days and also be included in the annual progress report.

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

Career Development and Training: BDSRC are expected to provide transdisciplinary research training and career development opportunities to graduate students and postdoctoral fellows. The Administrative Core component must describe plans for obtaining funds (or utilizing existing resources) to provide training and career development opportunities. Supplemental funding for training and career development could be sought from NIH institutional training grants (T32), individual fellowships (F31, F32), mentored career development awards (K01, K08) and other sources including, but not limited to, the parent institution and private foundations. These activities should be integrated into the research of the BDSRC and described in this Administrative Core component of the application.

Pilot Research Project Program: Pilot awards are intended to attract promising new investigators, or established investigators new to botanical research to the BDSRC and give them the opportunity to generate sufficient preliminary data to support the submission of competitive (in peer review) new botanical research applications. Clinical and human subjects research are excluded from the pilot program.  The Center must request funds to support pilot projects.  The application must include a description of the process for soliciting, reviewing, selecting, and monitoring pilot projects. The External Advisory Committee (EAC) must be involved in the review process for selection of pilot awards (e.g., directly as reviewers or indirectly as part of EAC oversight responsibilities). Potential projects to be included in this program should NOT be listed nor described in the application and will not be considered in the review of scientific merit.

Pilot research studies should be limited to a period of one to two years.  Not more than $100,000 (direct costs from the P50 award) per year may be devoted to all pilot research projects, including both newly supported and ongoing pilots.  Additional support of pilot projects through institutional, foundation, or other funding sources is welcomed. The first pilot studies should be awarded during the first budget year.

Pilot project funds cannot be awarded to the Center PD(s)/PI(s), Research Project Leaders, Core Leaders, or other scientists listed in the initial grant application.  Eligible applicants must be independent faculty at either the awardee institution or another member of the P50 consortium, and cannot have been otherwise supported by the P50 grant, or collaborated with Center key personnel on botanical research within the two years prior to receipt of pilot project support. Although both early stage and established investigators from the applicant institution or other P50 consortium institutions are eligible to apply for funding, established investigators are eligible only if they are new to botanical research. The pilot project research must be related to the Center theme and research aims.

Pilot funds cannot be used to assess the variability of botanical ingredients in botanical dietary supplement products available to consumers, because this activity is unlikely to advance the research of the center or to lead to applications for independent funding.

NIH program staff must be notified before funds can be expended to initiate pilot projects, to verify (1) that the pilot projects are within scope of the parent award, (2) have obtained EAC approval, (3) are in compliance with NCCAM's Natural Product Integrity policy and (4) comply with eligibility criteria described in the preceding two paragraphs.  The notification should include the proposal and specific research aims, the pilot research budget, and a biosketch(es) of the pilot study investigator(s).

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

This section should include a summary of the Center's track record during the prior award period in supporting training and career development of interdisciplinary botanical researchers, and in attracting promising new investigators to the pilot project program, as well as their contributions to the Center. Describe the subsequent achievements of trainees and early-stage investigators participating in the Center's research activities during the prior award period, as well as pilot project publications and any pilot projects that were successfully developed into new, peer-reviewed botanical research awards.

Letters of Support: Attach only letters of support relevant only to the Administrative Core in this section.

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

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

Planned Enrollment Report (Administrative Core)

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 (Administrative Core)

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

Research Core

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

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

SF424 (R&R) Cover (Research Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Core)

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

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

Project Narrative:  Do not complete.

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

List all performance sites that apply to the specific component.

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

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

Budget (Research Core)

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

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

PHS 398 Research Plan          (Research Core)

Specific Aims: Describe the Specific Aims for this Research Core. Each Botanical Dietary Supplements Research Center (BDSRC) application must include at least one Research Core that provides strong expertise in, and potential to advance research on the chemical components of plants and the interactions of those components.

Research Strategy: The Research Cores must provide infrastructure and result in increased productivity contributing to synergy of the research effort as a whole. It is expected that leaders of the Research Cores will play an integral part in developing the conceptual framework for the research conducted by the BDSRC, and that the Research Cores will not only support the work of the Research Projects, but also contribute to advancing the power of relevant methods and approaches (for example, but not limited to, increasing their efficiency, accuracy or predictive value). For example, a mass spectrometry core might develop new methods and innovative procedures that make a critical contribution to advancing the research of the BDSRC.

Clearly describe technologies or approaches that will be newly developed or newly adapted to botanical research and make clear in describing the relevant Specific Aims how these approaches are expected to contribute to increasing understanding of botanical effects on health in humans or relevant preclinical models. 

Each proposed Research Core must be utilized by a minimum of two Research Projects. 

Core resources should not duplicate resources already available to Center investigators. Where fee-for-service arrangements (i.e., Center use of existing facilities) satisfy analytical or other needs of the BDSRC, use of these is acceptable, but should not be considered as constituting, in and of itself, a separate Research Core.

Where applicable, validated methods and standard references materials such as those available via ODS' Analytical Methods and Reference Materials Program should be used.

Botanical Research Core

At least one Research Core in each proposed Center must provide strong expertise, and potential to advance research relevant to botanical research or a closely related discipline. The Botanical Research Core must provide in-depth expertise and capacity for quantitative and qualitative analysis of the chemical components and overall chemistry of botanicals.

The rationale for selection of specific botanicals for study should be clearly described either in the Botanical Research Core or in the applicable Research Project, and could include but is not limited to the following: history of use, prevalence of use, indications for use, the preclinical science base, and results of clinical studies.

Applicants are strongly encouraged to consult NCCAM’s Natural Product Integrity Policy (http://nccam.nih.gov/research/policies/naturalproduct.htm). Satisfactory Just-in-Time information on product integrity must be submitted before an application can be funded. Where research on the botanical product is a component of the BDSRC, information on plans to obtain, identify, characterize and optimize product may satisfy this requirement. This requirement applies to new and renewal applications. Centers submitting renewals will be required to submit documentation for new botanical test materials.

The Research Cores, like the Research Projects, will be encouraged to collaborate with related botanical or natural products research efforts, including the associated Center(s) for Advancing Natural Products Technology and Innovation (RFA AT-14-006).

Letters of Support: Include letters of support relevant only to this Core.

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

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

Planned Enrollment Report (Research Core)

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 (Research Core)

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

Research Project

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

Each Botanical Dietary Supplements Research Center application must include three or four active Research Projects during each year of the project period.

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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

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

Project Narrative:  Do not complete.

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Research Project)

Budget (Research Project)

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

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

PHS 398 Research Plan          (Research Project)

Specific Aims: Describe the Specific Aims for this Research Project.

Research Strategy: All research projects must be hypothesis driven and supported by preliminary data (new and renewal applications) and progress reports (renewal applications only).  The collection of Research Projects and Cores must be transdisciplinary, synergistic and consistent with the thematic focus of the Center. As a whole the Center must have strong potential to enhance progress in the understanding of complex botanical preparations used for human health, and each Research Project should make an important contribution towards that goal. Clearly describe how the proposed Research Project will integrate chemical analysis of complex botanical products with human health-relevant biological outcomes. The outcomes may derive from in silico, in vitro, preclinical in vivo or human subjects research and should have high potential to advance the elucidation of active components, their mechanisms of action, and/or their contribution to the overall activity.  Clearly describe technologies or approaches that will be newly developed or newly adapted to botanical research and make clear in describing the relevant Specific Aims how these approaches are expected to contribute to increasing understanding of botanical effects on health.

Projects focused on botanicals with a substantial history of human use, especially those botanicals used for health maintenance or improving resilience, are strongly encouraged. At least one third of the Specific Aims of the Research Projects in each proposed Center must include objective and quantitative outcomes with validated relevance or strong evidence of relevance to human health or resilience. Appropriate and translationally meaningful use of in silico, in vitro, and preclinical in vivo models, including invertebrate models, is strongly encouraged. At least one third of the Research Project specific aims should be focused on botanicals as they relate to resilience or health maintenance. These health/resilience-focused Specific Aims may be distributed among the proposed Research Projects as the investigators believe best suits the proposed research.

For basic/preclinical research projects investigators should describe the relevance of the proposed research to human health and the potential for translation to clinical practices.

The purpose of this FOA is to support the development of preclinical data that would allow the rigorous design of definitive clinical research on botanicals. Therefore Centers where all the Specific Aims of any of the proposed projects focus on human subjects or clinical research, or where more than one of the Research Projects includes human subjects or clinical research will be considered non-responsive and returned without review. Only applicants with demonstrated relevant expertise should propose human subjects or very early phase clinical research (for example, but not limited to metabolic or bioavailability studies).

Where applicable, provide the rationale for selection of, or for the approach to selecting botanical materials for study. This could include (but is not limited to) history of use, prevalence of use, indications for use, promising preclinical or clinical data.

To ensure reproducibility of the research, botanical materials must be rigorously identified, characterized, and documented. Applicants are strongly encouraged to consult NCCAM’s Natural Product Integrity Policy (http://nccam.nih.gov/research/policies/naturalproduct.htm) to be aware of the types of information that are required in the application, and in Just-in-Time information. Satisfactory Just-in-Time information on product integrity must be submitted before an application can be funded. This requirement applies to new and renewal applications. Centers submitting renewals will be required to submit documentation for new botanical test materials.

Where applicable, validated methods and standard references materials such as those available via ODS' Analytical Methods and Reference Materials Program should be used.

Letters of Support: Include letters of support relevant only to this Research Project.

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

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

Planned Enrollment Report (Research Project)

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 (Research Project)

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review 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.

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

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is successful achievement of the Center's overall Specific Aims likely to lead to definitive assessment of the potential of one or more orally ingested botanical products for improving health or resilience in objectively measurable ways, or to significantly improve upon current approaches to assessing, and understanding of mechanisms of action, safety and/or efficacy of orally ingested complex botanicals?  

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do(es) the Center PD(s)/PI(s) have track record(s) of consistently producing highly significant research publications in one or more of the research areas proposed for the Center?  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? Will successful achievement of the Center's overall Specific Aims develop and/or demonstrate the value of new approaches to assessing the content of complex botanical products and their effects when consumed by humans or other animals?

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?

Is there a well-reasoned and appropriate plan for the proposed Center to integrate chemical analysis of complex botanical products with human health-relevant biological outcomes (including outcomes derived from in silico, in vitro, preclinical in vivo, or human subjects research)? Does the proposed research have high potential to advance the  elucidation of active components, their mechanisms of action, and/or their contribution to overall human health-relevant effects?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of substantial institutional commitment on the part of each participating institution?  Is there evidence of prior productive collaboration of the research team (including in the P50 application)?  Are the application and investigator track records indicative of the establishment of a strong collaborative environment?

Additional Review Criteria - Overall

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

Synergy

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

Program synergy will be evaluated on the extent to which the combined approaches to the research question(s) proposed for the BDSRC are synergistic, and the integration and parallel pursuit of the projects and cores are likely to advance this research area to a greater extent than could be achieved without Center support. The presence of Administrative and Research Cores does not, in and of itself, constitute or guarantee synergy.

Assessment of synergy will include the following:

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

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

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.

Review Criteria for Administrative Core

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

Review Criteria for Research Cores

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

Review Criteria for Individual Research Projects

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

Significance

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

Investigator(s)

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

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?

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

For proposed model systems (in silico, in vitro or in vivo), are the strengths, weaknesses, and caveats relevant to eventual translation to clinical research carefully considered and addressed? Are proposed outcome measures validated in the context in which they will be used, or likely to be demonstrated to be valid in the context in which they will be used?

Are plans to develop novel technologies or adapt approaches from related fields to enhance botanical research clearly described and likely to be productive? Are plans to develop novel approaches or to adapt approaches from related fields to improve the integration of data from phytochemistry and model system or human subjects research to advance understanding of botanical mechanism(s) of action on human/other animal health clearly described and likely to be productive?

Is the rationale for selection of, or for the approach to selecting, botanicals for study clearly described, and is it sound?

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 - 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.

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

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

Revisions

Not Applicable

Additional Review Considerations - Projects

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) convened by NCCAM, 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 National Advisory Council for Complementary and Alternative Medicine. 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.

Prior Approval of Pilot Projects

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation, and are not permitted for awards under this RFA. 

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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)

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

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

Peer Review Contact(s)

Dale Birkle Dreer, PhD
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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