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Preapplication Webinar for RFA-OD-19-001, Botanical Dietary Supplement Research Centers (BDSRC) (U19 Clinical Trial Optional)

SUMMARY


Purpose of the Webinar
On Tuesday, February 12, 2019, the National Institutes of Health (NIH) National Center for 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 Botanical Dietary Supplement Research Centers (BDSRC), RFA-OD-19-001, one of the components of the NIH Consortium for Advancing Research on Botanicals and Other Natural Products (CARBON).

Webinar Speakers

  • Barbara C. Sorkin, Ph.D., Director, Botanical Research Centers Program, ODS
  • 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).

Shelley Carow, Chief Grants Management Officer, Office of Grants Management, NCCIH, and D. Craig Hopp, Ph.D., Deputy Director, Division of Extramural Research, NCCIH, were also available to answer participants’ questions.

Note: Dr. Sorkin’s presentation focused on aspects of the request for applications (RFA) that are particularly complicated or different from other RFAs. The Roman and Arabic numbers on some of the slides indicate sections in the RFA where this information can be found.

Overall CARBON Structure

The BDRSC is one component of the CARBON program. Other components of CARBON include centers for collaborative development of innovative natural product methods and a natural products nuclear magnetic resonance (NMR) raw data repository.

As described in Sections I.2.1, IV.1, and V of the RFA, applicants are required to describe potential areas of collaboration between their proposed BDSRC and other components of the 2020-2025 CARBON. Examples of possible future collaborations include:

  • Collaborations with other BDSRC awardees working with different products or with outcomes requiring specialized expertise to pursue additional, perhaps unexpected activities of products.
  • Leveraging and helping to beta-test the innovative methodologies being developed by the methodology development centers (U41 centers). Each application will still need to demonstrate that the proposed Center has the requisite expertise to accomplish the Center’s specific aims. Collaboration with a U41 center might deploy additional methodology to ask bigger or deeper questions, or to get results faster.

An estimated budget for these proposed collaborative projects should be included in the Administrative component of the application.

Objectives

The objective of this FOA is to address the most critical gaps in information needed for future design (by the applicant or others) of optimally informative clinical trials (CTs) of (orally) ingested, complex botanical product(s). Taking into consideration that each CT entails myriad design decisions, some of which will likely have stronger effects on trial outcomes than others, applicants must set forth an evidence-based case that achieving the proposed Specific Aims will provide key information toward design decisions for the anticipated future CT, and that the future CT is likely to rigorously inform practice or other health-critical next steps.

Within that objective, and beyond the required focus on ingested, complex botanical product(s), RFA-OD-19-001 has additional very specific requirements. Applicants unable to meet these requirements may wish to consider other available natural product–focused or parent FOAs.

Rigorous evidence must be provided for a clinically or public health–significant and reproducible effect of the proposed complex botanical product(s) on quantitative, objective outcomes relevant to human biological or cognitive/behavioral resilience. Resilience is defined, for the purposes of the RFA, in Section I, which also describes the botanicals of interest for the RFA.

RFA-OD-19-001 sets a very high bar for preliminary data and justification of research approach. In addition to the standard review criteria, applicants must provide, and reviewers are asked to assess:

  • Do the data support the likelihood that a future CT based on results from the BDSRC could, through enhanced understanding of the effects of the product(s) studied, meaningfully and significantly affect a prevalent health issue?
  • Do they support the likelihood that achievement of the Specific Aims of the application will provide information that will significantly inform and enhance the design and/or interpretation of such a trial?
  • Has the applicant compellingly explained why the knowledge gaps addressed by this proposed Center are priorities for the rigorous, evidence-based design and or better-informed interpretation of a future CT?
  • Are data provided that rigorously demonstrate the presence of one or more bioactive components (or their precursors) in the product; that the orally consumed product can generate a concentration in vivo, preferably at the presumed proximate target, sufficient for activity; and that the presence in the intervention of the proposed bioactive(s) or precursor(s) is necessary for a project-relevant proximate biological effect or health outcome, or both?
  • Is evidence provided that the applicant is able to meaningfully monitor product quality, bioavailability, and pharmacokinetics based on one or more of these proposed bioactives?
  • Are choices evidenced in the application (intervention, population, outcomes) well justified, based on the evidence provided or cited?
  • How rigorous and robust, mutually consistent, and relevant to the future CT, are the data cited or provided in support of the current application?
  • If such studies are not reported in preliminary data, are strong plans described in the application to evaluate the presence of additional (beyond those described in the application) bioactive compounds (or their precursors) in the botanical products used in the project, as well as to evaluate the possibility that the bioactives to be studied act on additional in vivo targets (beyond those already described)?

BDSRC Structure

As described in Section I.2.1 of the RFA, each center must have one botanical research core, an administrative core or administrative structure, and exactly two research projects. All of the research components must synergize with each other.

  • Botanical core:
    • Needs to ensure that there is a product of sufficient quality, available in sufficient quantity for the BDSRC research to proceed smoothly.
    • Must describe results from, or propose a rigorous approach to assess the potential presence of other bioactives or bioactivities in the product that could modify the outcome.
  • Administrative core or administrative structure must:
    • Clearly describe detailed, feasible plans for the governance and coordination of the BDSRC, including coordination and management of research prioritization, required reporting, evaluation of Center activities and progress, effective sharing of resources and data, Internal Steering Committee, External Advisory Committee, and collaborations.
    • Include a program director/principal investigator (PD/PI) as the administrative lead.
    • Describe plans for the development and maintenance of a website that will show the outside world what the center is doing. (The funding for the website cannot come from the U19 award.)
    • Describe plans for obtaining or leveraging funds for career development activities for junior researchers. (The funding for such development activities cannot come from the U19 award.)

Clinical research / human subject research is optional for the BDSRC. If included, it cannot be in the administrative component. It can be in the botanical core or in one or both of the research projects. If the clinical/human subjects research is associated with multiple components of the center, it should be included in the overall component of the submitted application.

BDSRC are cooperative agreements, as described in Section VI.2 of the RFA, and require:

  • An internal steering committee, which should be described in the administrative component of your application.
  • An external advisory committee. You need to identify and justify the number of reviewers on your external advisory committee and the reviewers’ expertise. Do not, however, name the reviewers because that would put them in conflict for purposes of review. (If they are serving on the external advisory committee of a current BDSRC, they are in conflict anyway.)

Responsive Research

BDSRC where the main research focus is a purified phytochemical are not responsive. Specific aims using purified phytochemicals to elucidate the molecular mechanism(s) of action in an in vitro model may be included but must be geared toward understanding the biological activity of the more complex product.

Applicants must address issues of rigor. In particular, preclinical models must be well justified for the research questions asked. Reviewers are asked to assess how the applicant has addressed differences between preclinical models and human biology that will be important when moving toward a CT and the approaches the applicant has proposed for addressing those differences.

Examples of responsive, in-scope projects include:

  • Further elucidation of causal molecular mechanisms (e.g., cooperating components at target)
  • Noninvasive approaches to detecting proximate biological activity
  • Optimization of product formulation (not production scale-up or synthetic modification)
  • Assessment of pharmacokinetics/pharmacodynamics (PK/PD)
  • Dose optimization
  • Outcome optimization
  • Response predictors (eligibility criteria optimization).

Eligible Institutions and Budget

A variety of U.S. institutions, including universities, nonprofit organizations, and small businesses, are eligible to apply (RFA section III). Only one application is allowed per institution. Foreign institutions are not eligible to apply, but they can be included as a collaborators.

The budget limit for this RFA is unusual because it is based on total costs. (Total costs equal direct costs plus indirect costs.) The budget limit is $1.2 million total costs per year. The budget must include funds to cover the travel of key personnel to the annual CARBON meeting. The award cannot be used for the website, consumer information, or other outreach activities.

National Institute on Aging Research Interests

The National Institute on Aging (NIA), through NOT-AG-19-006, has indicated its participation in this RFA. The responsible program director at NIA is Dr. Giovanna Zappalà. NIA has set aside $500,000 total costs in fiscal year 2020.

NIA is interested in botanical products with strong supporting evidence for modulating resiliencies to physical or psychosocial stressors in older adults and in the study of age-related changes in resiliencies.

Relevant examples of resilience outcomes of interest to NIA include:

  • Cognitive
  • Neurodegenerative
  • Inflammatory
  • Metabolic
  • Microbiota
  • Glucose and/or lipid homeostasis
  • Sacrcopenic obesity
  • Wound healing.

Submission Deadline

Applications are due April 15, 2019, by 5 p.m. local time of the submitting institution.

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. PIs are encouraged to read the FOA thoroughly to determine what components are necessary to include in the application.

For this initiative, letters of support are among the factors that determine compliance. For the overall component, a letter of institutional commitment from the dean or another official of similar rank must be included. For a consortium that will involve multiple institutions, similar letters of support from each participating institution must be included. Letters of support for the administrative core, botanical core, and research projects are also allowed.

The U19 application requires multiple components. Compliant applications will include an overall component, an administrative core or structure, a botanical core, and two research projects.

Page limitations for the research strategy sections of each application component will also determine compliance and are as follows:

  • Overall component: 12 pages
  • Administrative core: 6 pages
  • Botanical core: 12 pages
  • Research projects: 12 pages per project.

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

Review Structure

The review of multicomponent applications, such as those submitted in response to this U19, differs from that of typical R01 applications. For the U19, reviewers will first discuss each research project separately and provide a numerical impact score for each. These scores will not be released to the PIs. Next, reviewers will discuss and provide separate merit descriptors for the botanical core and administrative core or structure. The merit descriptors will not be released to the PIs. Following that discussion, the reviewers will discuss the overall component and provide a numerical impact score for the Center as a whole. The average score of the overall component will be released to the PIs.

The overall component and research projects will be scored for five review criteria: significance, investigators, innovation, approach, and environment. Reviewers will give separate criterion scores for each of these five areas. Reviewers will also assess additional review criteria for the overall application and for applications that include a CT.

The reviewers will balance the five scored review criteria and the additional review criteria to determine the final score for each research project and the overall Center application. Additional language has been added to the five standard review criteria for this RFA. All aspects that reviewers will be asked to address in their critiques match exactly what applicants are asked to address in the application. Therefore, it is important for PIs to read the review criteria carefully.

Reviewers will not assign numerical scores for the administrative component and botanical core. Instead, each component will receive a merit descriptor (outstanding, acceptable, unacceptable). These components do not use the standard review criteria. Instead, they have specific review criteria that should be addressed in the application. For applications that involve CTs, there are also review criteria specific to CTs.

Letters of intent are requested but not required. If you submit a letter of intent, you are not bound to submit an application. Letters of intent should include the title of the proposed project, PI’s name and institution, and names of key personnel and their institutions. Send letters of intent to Dr. Martina Schmidt at schmidma@mail.nih.gov.

Applications submitted in response to this RFA will be reviewed by a Special Emphasis Panel. Reviewers will be selected based on their specific area of expertise in the target areas of the FOA and the science proposed in the applications. Reviewers will be oriented to use the review criteria added to this FOA and the additional review criteria in their assessments.

Questions and Answers

Q: The RFA is somewhat ambiguous about the administrative core in two places. It says “An Administrative Core is NOT required,” but under the submission instructions, it says “Administrative Core/Structure: 1 Required.” Assuming that the former is correct, how can an application be submitted if a component is required in eRA?
A: There are the required components of the application that you’ll be submitting, and then there are the required components of the research project itself. The application needs to be a clear representation of what you’re planning to do. The application must be submitted with an administrative component. That administrative component needs to clearly describe how you’re going to coordinate and administer research and communications within your BDSRC and with any collaborating CARBON components. That can be via a classical administrative core, or you can use the administrative component to describe how you will achieve all of the functions required from the administrative core, including:

  • Coordination of an Internal Steering Committee and External Advisory Committee in conjunction with the NIH Project Scientist(s)
  • Ensuring compliance with award requirements, including reporting requirements, website development and maintenance, and development of approaches to obtain support from other sources for training and career development of students and postdoctoral fellows
  • Coordination and prioritization of product and data quality control and availability
  • Conflict resolution.

Because different institutions and different research projects have different structures, expertise, and requirements, it is up to the individual applicant to determine the best approach for their application.

Q: The RFA states that “If an Administrative Core is not proposed, the investigators must describe in this Administrative Core/Structure component how all the functions otherwise required of an Administrative Core will be structured and performed in the proposed BDSRC.” What is the administrative core structure component in an application that does not have an administrative core? And where in the BDSRC project structure and budget is the PD located if the project does not have an administrative core?
A: We divide the answer to the question as follows: Where in the application, where in the structure of the research center itself and where in the budget should the PD/PI be indicated if an administrative core is not proposed? There must be a PD/PI for the BDSRC as a whole, who must be named in the overall component of the application, but the only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. Usually the PD/PI for a center is also involved in one of the research components, whether it be the botanical core or one of the research projects. The Admin component of the application does include a budget for the coordination and administration required to ensure that the center is productive, synergistic, appropriately collaborative, and compliant with relevant policies and requirements. Sufficient effort and budget to ensure the efficient function and coordination of the BDSRC should be requested. The Admin component of the application would appear to be the logical place for that, even if the applicant is not proposing an Administrative Core. If you have additional questions related to this, you can email Dr. Sorkin at Barbara.Sorkin@nih.hhs.gov.

Q: If the applicant decides to not propose an administrative core, will the eRA accept the application or will it be rejected because, as part of the RFA, the administrative core is required?
A: The administrative core is not required. The administrative component of the application is required. If you are not proposing an administrative core, you still need to use that component of the application to explain how you will administer and coordinate the various components—research projects, botanical core, internal steering committee, external advisory committee, and other elements—that go into creating a productive, synergistic, smooth-functioning center. If you don’t have an administrative component, your application will not go through grants.gov.

Q: Does the FOA require us to find alternative funds to support career development activities? Do you have examples of how this has been done before?
A: A T32 is an institutional training award, and it provides funds to support a variable number of “slots” for either predoctoral or postdoctoral trainees to obtain training in the context of the institution. Many past and current botanical centers have worked with T32 awards focused on natural products and botanical research, either at the awardee institution or a collaborating institution. We also encourage you to confer with the PD/PIs of the current BDSRC.

Q: Are more than two cores allowed? How does that affect page limit?
A: You are allowed one administrative core and required to have one botanical core. The page limits for each core are as indicated in the RFA. No other cores can be accepted.

Q: Where would a metabolomics/proteomics/RNS sequence/animal/human studies core fit in a botanical core? Should these assays or cores be put in both of the projects?
A: You cannot have a separate core for metabolomics. Dr. Sorkin is happy to discuss with applicants where in their center such activities might be best placed.

Q: Two research projects are required. Are more than two research projects allowed?
A: Two research projects are required, and no more than two are allowed.

Q: Can there be multiple institutions participating in one BDSRC? (For example, can there be one institution serving as the botanical core apart from the administrative aspects and projects?)
A: Yes, multiple institutions can participate in one BDSRC. You will need to explain in your overall and administrative components how that will be coordinated and how it will work in terms of budget, personnel, communications, getting product back and forth to research projects, and getting data back and forth.

Q: Is there a prescribed or minimum number of natural products to study?
A: The entire center could be focused on one product. The goal of the center is to develop data so that your next step is a CT, where what you learn from the BDSRC research will help optimize your chances of rejecting the null hypothesis in that CT, and of gaining actionable new information from that trial even if, as happens in the majority of CTs, you fail to reject the null hypothesis.

Q: How many botanical dietary supplement products could one center or program propose to study?
A: We did not put a limit on the number of products that you could propose. Having said that, given the very high bar, you need to make a very strong case for any product that you’re proposing. Keep in mind that there is a budget limit of $1.2 million total costs per year and that your goal is to generate the necessary data to do an optimally designed CT from which you are almost guaranteed to learn something useful.

Q: Do the preliminary data need to come from the applicant’s lab, or can we use literature data and show capability of achieving the project goals in our lab?
A: The preliminary data don’t need to come from your group. If the preliminary data don’t come from your group, then you do need to show that you can continue the research. Whether or not the preliminary data come from your group, you will want to address the rigor of the data very carefully in your application because reviewers will be looking at whether the data are strong enough to be pursued.

Q: Can the work relate to botanical doses or extracts that are different from those in common use as commercial dietary supplements?
A: Yes, it can. The goal is to optimize the CT. Looking at different extracts and different preparations could potentially be a great way to understand the chemistry or chemical components required for activity and for increasing or inhibiting activity. Safety considerations for CTs are of paramount importance; while critical for all products, special attention may be appropriate for products that differ from those in traditional or common use.

Q: Complex botanicals work in an animal model, reproducibly. Do we need to know active ingredients before submitting the U19? Can we find active ingredients through center funding?
A: For this RFA, you are required to provide evidence in your application—from your group or published by others—that strongly supports at least one bioactive component or bioactive precursor in your product that is required for activity, so that coming in, you can use that information to standardize your product and to assess bioavailability and pharmacokinetics. You are also required to describe an unbiased or untargeted or agnostic approach to look for other additional bioactives in your product(s), unless such studies have already been done and you’re reporting the results in your supporting data.

Q: Can one of the projects or the botanical core involve developing methods to cultivate and/or optimize cultivation of the botanical material?
A: Yes. If you can make the case that different growing conditions would increase the content and biological activity of the product, you can potentially do that. Within the narrow frame of this RFA, we provide a lot of options to do the research as you see best. Note that research focused on the development of methods to improve large-scale production of individual botanicals or their derivatives is an excluded research area; projects proposing this will be considered nonresponsive and will not be reviewed. Applicants must provide evidence that they will have, or will have, sufficient product that meets their specifications to do the proposed research.

Q: Can the botanical core come from the private sector, such as an industry, pharma company, or small business?
A: Any of those are acceptable as long as you make a case that they can help you to achieve your specific aims.

Q: Is it acceptable that the botanists of a botanical core be part of the institution hosting the core and the institution of the PI? Or is it better to have them only at the site of the botanical core?
A: It should be whatever the best way is to accomplish the specific aims in a synergistic and efficient manner. You need to explain that in your application and convince the reviewers that it will work on the budget that you are proposing.

Q: Do the botanical core and research projects need to be from the same institution?
A: Collaboration between different institutions is allowed. You need to make the case in your application that product and information can transfer efficiently enough between the botanical core and the research projects so that you can achieve your specific aims.

Q: Are the components limited to botanical products, or can they be other natural compounds?
A: For the purposes of the BDSRC, the products need to be complex botanical products. They need to be products that would be of interest for CTs and that are taken by mouth, by ingestion.

Q: Does the PI of the center grant need to head one of the two projects?
A: No, that is not a requirement of the RFA.

Q: Do the PI, co-PIs, core leads, and project leads have to put forth a minimum percentage effort?
A: We have not indicated any minimum percentage effort for PD/PIs, core leads, and project leads.
In your application, you need to convince the reviewers that are you are dedicating enough effort to the research and to the research administration and that you will be able to achieve the specific aims within the 5-year project period.

Q: Are multiple PD/PIs allowed?
A: Yes, multiple PD/PIs are allowed. Within the FOA is a link to application instructions regarding multiple PD/PIs, and we encourage you to access that. If you have multiple PD/PIs, you’ll need to explain how you are going to split efforts, the division of labor, and why multiple PIs are needed. In addition to multiple PD/PIs, you may also have collaborators and coinvestigators. Depending on their role, they may or may not be key personnel. If they are key personnel, you need to provide their biographical sketches and a detailed description of their role on the project.

Q: Should applicants describe a plan to solicit and support pilot projects?
A: No. NIH will develop an approach for pilot projects for the next iteration of CARBON.

Q: Please clarify how our center is supposed to interact and synergize with other CARBON components of which we won’t be aware?
A: From the structure of the consortium, there are certain things that you know about the other centers. For instance, the U41 centers will be developing innovative methods. And the other BDSRC besides yours will be doing research on complex botanical products for resilience outcomes. There might be other outcomes that you would be interested in exploring for your product, or there might be other products that you would be interested in exploring for your outcome. Either of those approaches might shed additional light on the biology or product chemistry that you’re interested in and could be potential areas for collaboration. Of course you cannot finalize what the collaborations might be until you see who the other awardees are and begin to talk to those people.

Q: For the synergy with other CARBON units, should we include funds in our budget to use services or collaborative research with the other BDSRC NP-TEMPO or NMR NODE partners?
A: Applicants should include estimated budgets for the collaborations in the Admin component of the application and describe potential areas of collaboration in the overall section and appropriate Research Projects/Botanical Core. Plans to initiate such collaborations, and to ensure their efficient coordination and reporting and effective oversight, should be included in the Admin Component of the application.

Please do NOT name potential future collaborators.

Q: The RFA states that the U19 grantee must collaborate and interact with the other CARBON recipients. Do these interactions or projects need to be budgeted and planned in this U19 proposal even though the other CARBON grantees are not known yet?
A: You are required to describe areas of potential collaboration. Without knowing the other future awardees, you can’t know the specifics of the collaboration. But there should be enough money in the budget to be able to support the collaboration. Any collaboration will have to be within the scope of your award and specific aims.

Q: Must the U19’s budget allow for the future interactions of the proposed collaborations, or can additional funds be solicited at a later date?
A: At this point, we do not expect to provide supplemental funding for the collaborations.

Q: Do we have to demonstrate in the application that our center fits well within the U24 NODE or U41 NP-TEMPO?
A: No, that is not a requirement, and certainly not every center has NMR experts or would be producing NMR data. You will need to indicate in your application that there are areas of your proposed research that would be appropriate for collaborative projects or collaboration with other potential CARBON components. You are not required to collaborate, though we like to see collaboration; it appears to us such collaboration leverages our investment in the program and that it creates intercenter synergies as well as intracenter synergies—that is what we’ve seen in the current program and is what we are eager to see in the newly awarded program. We would not expect Centers to engage in collaborations that do not benefit their research.

Q: Ideally how do the U19 and U41 fit together cooperatively?
A: We don’t expect there to be a lot of language in your application about exactly how that cooperation is going to happen. With these being cooperative agreements, we can work with all of the grantees after the awards are made to manage the cooperation and determine ways that it can occur most effectively. With the current awards, all of the BDSRC are collaborating with at least one if not both of the innovative research method centers, the U41’s.

Q: Is a website required?
A: Yes.

Q: Why can’t center funding be used to create the required website?
A: The reason is as stated in the NIH Grants Policy Statement. Applicants with further questions should consult their organization’s grants office.

Q: How do we fund a website if we are not allowed to allocate funds to it?
A: Sufficient funds must be allocated to the development and maintenance of a BDSRC website, but those funds cannot come from the U19.

Q: Can you describe the unique characteristics for an acceptable and outstanding botanical core and the differences between them?
A: If you look at the review criteria in the RFA, you will see a list of questions that all applicants should answer as they are writing their botanical core as well as their administrative core. Reviewers are going to assess your responses to all of those criteria, and they will assess whether your core is outstanding, acceptable, or unacceptable. If you meet all of the review criteria for a core and the reviewers are satisfied, it is probably acceptable. If you meet all of the review criteria for a core and the reviewers think it is highly creative and likely to have high impact, it is probably outstanding.

Q: How does one apply for the NIA funding and how is it awarded?
A: There is no difference in the application process. How the NIA funding gets applied will be an invisible process to the applicants. You are, however, encouraged to consult with Dr. Zappalà if you think your project might be appropriate for NIA cofunding. You can email Dr. Zappalà at giovanna.zappala@nih.gov.

Q: How many BDSRC do you plan to fund?
A: The RFA indicates that we plan to fund up to three.

Q: There are three current BDSRC and three awards planned for this RFA. How will the program ensure that new applicants will be reviewed fairly given that new applicants will be competing directly with the existing BDSRC and that new applicants will not have the pre-existing structure of a BDSRC already in place?
A: There are several approaches that are expected to ensure fair review of all applications. 1. There are clear rules regarding presence of reviewers with conflicts during peer review. 2. Having a track record works both for and against an applicant. Having past support may have contributed to productivity, but it may also increase reviewers’ expectations for a strong track record of accomplishment. The program has been in existence for 20 years, and over those 20 years there have been new awardees each time NIH has issued new awards.
The FOA is technically accepting only new applications, not renewal applications. Prior BDSRC awards used the P50 funding activity, so applications from current BDSRC awardees are also technically new applications.

If you have any additional questions, please send an email to Dr. Sorkin at Barbara.Sorkin@nih.hhs.gov, Dr. Hopp at hoppdc@mail.nih.gov, or Dr. Zappalà at giovanna.zappala@nih.gov.

Applicants with financial or grants management questions should first consult their organization’s grants office.