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Webinar for RFA-AT-19-002, Natural Products NMR Open Data Exchange (NP-NODE) (U24 Clinical Trial Not Allowed)

SUMMARY


Purpose of the Webinar

On Monday, February 11, 2019, the National Institutes of Health (NIH) National Center on Complementary and Integrative Health (NCCIH) and Office of Dietary Supplements (ODS) hosted a preapplication technical assistance webinar to provide information for applicants about the funding opportunity announcement (FOA) for the Natural Products NMR Open Data Exchange (NP-NODE), RFA-AT-19-002, one of the components of the NIH Consortium for Advancing Research on Botanical and Other Natural Products (CARBON).

Webinar Speakers

  • D. Craig Hopp, Ph.D., Deputy Director, Division of Extramural Research, NCCIH
  • Ashlee Tipton, Ph.D., Scientific Review Officer, Office of Scientific Review, NCCIH
  • Anita McRae-Williams, M.A., Outreach Communications Program Manager, Division of Extramural Research, NCCIH (Webinar Moderator).

In addition, Shelley Carow, Chief Grants Management Officer, Office of Grants Management, NCCIH, was available to answer participants’ questions.

Background on the Funding Opportunity

This funding opportunity is part of the larger research effort that constitutes the CARBON program, which is also expected to include botanical research centers and a center for collaborative development of innovative natural product methods. The U24 funding activity is specifically designed to support resource centers; NIH uses the U24 to fund the development of resources for the research community, such as this data repository.

There are almost 100 existing NIH-supported data repositories. NIH’s interest in repositories is linked with its commitment to the FAIR data principles—that is, making data Findable, Accessible, Interoperable, and Reusable. Each discipline must make its own decisions about how best to accomplish this. One possible tool for the future is the STRIDES Initiative, which will establish partnerships with commercial cloud service providers. However, this resource is not fully in place yet.

Capabilities Expected of Successful Grantees

Specific capabilities that successful grantees are expected to develop through the U24 include:

  • A cloud platform to house raw nuclear magnetic resonance (NMR) data.
  • A user-friendly interface to allow for upload, download, search, and analysis of NMR data in the repository.
  • Tools and consensus standards to facilitate widespread utilization of the repository.
  • Development and sharing of additional tools by the larger natural products research community to leverage the repository data; collaborative development of consensus standards for what metadata to include.
  • The ability to coordinate information standards across the natural products research community that are compatible with existing standards, such as herbal CONSORT, ARRIVE, and the NCCIH Natural Product Integrity Policy (PIP).
  • The ability to assist NIH’s NCCIH and ODS with implementation of the PIP.

NP-NODE will involve collaboration not just within the U24 but also in the natural products community. Your application should describe the types of people or organizations you expect to work with, but you should not name each specific individual. You should explain how you will engage these stakeholders to establish key features of the repository. This project will be to some extent a community effort, and a degree of consensus across the natural products community is necessary. You should explain how you will populate the repository, including the strategies for encouraging, requiring, or rewarding data deposition. In addition, your application should explain your strategy to promote FAIR data principles and your approach to advising on PIP compliance.

Structure of the U24

The U24 funding mechanism is a cooperative agreement. This means that NIH staff will be heavily involved in the project, with conversations at least monthly in the early stages or more often if needed.

Most of the effort on the project (about 65 percent) must be on the repository, with smaller proportions devoted to broader implementation of FAIR principles in the natural products research community (about 25 percent) and consultation on the PIP (about 10 percent). These percentages are estimates, and the proportion of effort devoted to the repository could be higher than 65 percent.

Eligibility and Budget

A variety of U.S. institutions, including universities, nonprofit organizations, and small businesses, are eligible to apply. Foreign collaborators are allowed and are appropriate if the expertise you seek is not available within the United States. Applications from foreign institutions will not be accepted. An organization may submit more than one application, but they must be scientifically distinct.

The budget for this project will be $600,000 in direct costs per year for up to 5 years. This number excludes consortium costs. The budget must include funds to cover the travel of key personnel to the annual CARBON meeting.

Remember to read the entire RFA carefully, describe how your effort will succeed where others have failed, and contact Dr. Hopp by email at hoppdc@mail.nih.gov if you have questions. Once you have established contact by email, you can set up a time for a telephone conversation.

Review Perspective

The completeness, compliance, and responsiveness of your application are of the utmost importance because applications that are incomplete, noncompliant, or not responsive to the RFA will not be reviewed.

Factors that determine compliance include the Resource Sharing Plan, which must comply with the instructions provided in the SF424 (R&R) Application Guide, and the Data Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan.

Applications must be responsive to the Research Objectives of the RFA. Responsiveness will be determined by program staff. When reading the FOA, it is helpful to refer to the “Specific Areas of Research Interest” and to search for words like “must,” “should,” and “need.”

Applications will be assessed based on the 5 standard review criteria: Significance, Investigators, Innovation, Approach, and Environment. Each of the 5 standard review criteria will receive a numerical criterion score. In addition to the scored review criteria, reviewers will also assess additional review criteria. Together, all these criteria will be taken into consideration in determining the Overall Impact Score. Additional language has been added to the five standard review criteria for this RFA. Applicants should address in their applications all the aspects that reviewers are asked to assess in their critiques. Please make sure to read the review criteria carefully.

Letters of intent are greatly appreciated but not required. They should include the title of the proposed project, principal investigator’s name and institution, and key personnel and their institutions. Send letters of intent to Dr. Martina Schmidt at schmidma@mail.nih.gov.

Applications will be reviewed by a Special Emphasis Panel. Reviewers will be selected based on their specific areas of expertise in the target areas of the FOA and the science proposed in the applications. Reviewers will be oriented to use the specific review criteria for this FOA. Applications should address how the proposed project would be impactful considering the goals of the FOA.

Questions and Answers

Q: Do you have any guidance on how the application should describe collaborations with U.S. or foreign experts?
A: NCCIH wants this to be a collaborative effort, potentially a global one. Applicants should describe the types of people they expect to work with. If you expect that you will work with someone extensively, that person would qualify as key personnel and should be named. However, do not include the names of every person you would talk to while developing your registry. Including all those names would complicate the scientific review of your application.

Q: What are the expectations for the number of spectra to be included in the repository during the early years of the project, and where would the spectra come from?
A: Ultimately, it is hoped that the repository would include tens of thousands of spectra. However, in the early stages, it may be difficult to get people to volunteer spectra, so early spectra might have to come from the grantee or other labs that agree to supply them. The burden on people who submit spectra, at least in the early stages of the project before standards have been put in place, should be very low. It is desirable to include as many spectra as possible, so the need for a well-curated library of spectra will have to be balanced against ease of submission. NCCIH and ODS will work with the grantee to manage this process.

Q: If you submit a letter of intent, are you obligated to submit an application?
A: No. Submitting an application is not required, and applicants are not bound by the information they provided in their letters.

Ms. Carow commented at this point about the roles of grants management personnel and program officials. The grants management office is responsible for the negotiation of the award, the administration of the project, and the interpretation of grants management policies. Program officials are responsible for the scientific, programmatic, and technical aspects of the project. Grants management and program officials work together in overall project administration. If you are awarded a cooperative agreement, make sure that the authorized business official from your institution works with the grants management office.

Q: Can you provide examples of previous databases that have not endured?
A: Not specifically. But it would be worthwhile to do research to find them. There have been a few NMR data repositories, but they were small and not successful.

Q: Are there any specific instructions for the natural products NMR database to interface with other public databases such as PubChem?
A: You should make it possible for the data to be integrated with other databases. This requires your ontology to be compatible with the way compounds are described in the other databases. An example is given in the RFA of using structures stored as SMILES strings to allow for seamless integration with other data repositories.

Q: Can funds be used to generate spectra of purchased authentic standards? If so, how many? Is there an upper budget limit for these exercises?
A: The intent of the U24 is to build a community-generated repository of NMR spectra. Thus, the preference is to foster collaborations and relationships with external groups to encourage them to deposit their spectra. Furthermore, it is assumed that the successful U24 grantee will likely have direct access to NMR spectra they have acquired previously that can be added directly to build the repository. However, there could be scenarios where it would be advantageous to acquire specific compounds and obtain their NMR spectra de novo. One example would be if a diverse collection of compounds was needed to build a reasonably broad training set to develop preliminary search and comparison tools for the repository. Such efforts would be permissible but should represent a small portion of the overall activities. Most of the effort should be spent working with others to build the repository.

Closing Remarks
Participants who have further questions should contact Dr. Hopp by email at hoppdc@mail.nih.gov.