Wednesday, July 17, 2013
Purpose of Teleconference: On Wednesday, July 17, 2013, the National Center for Complementary and Alternative Medicine (NCCAM) convened a pre-application teleconference to provide technical assistance to prospective grant applicants. The teleconference provided an overview of the research grant submission process, including an in-depth discussion of the funding opportunity, and explained the peer-review process. The teleconference also addressed participant questions received via telephone and e-mail.
Application Receipt Dates: August 2, 2013
John Williamson, Ph.D., NCCAM, Program Director
Craig Hopp, Ph.D., NCCAM, Program Director
Peter Kozel, Ph.D., NCCAM, Scientific Review Officer
Anita Greene, M.A., NCCAM, Outreach Program Manager (Moderator)
Important information provided about this funding opportunity announcement (FOA) by NCCAM and specific questions and answers asked during the teleconference appear below:
Important Information About the Program Announcement
- The purpose of the Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) FOAs is to stimulate technological innovation in the private sector, strengthen the role of small business in meeting Federal research and development needs, and to improve the return on investment from Federally-funded research for economic and social benefits.
- Only applications for Phase 1 for both FOAs will be accepted.
- General questions or interest about the program specifics are located on NIH’s Web site.
Administrative Points Regarding the FOA
- Both SBIR and STTR programs are mandated by Congress and require those agencies that provide significant grant support to set aside a certain portion of their budget to the these programs. For the STTR program, NIH is required to reserve 0.35 percent of the extramural research budget. For SBIR awards 2.7 percent is set aside. NCCAM and the National Center for Advancing Translational Sciences have committed $1.25 million for the SBIR program, and $250,000 for the STTR program.
- The STTR and SBIR differ in several ways. In SBIR grants, the principal investigator must have primary employment with the Small Business Concern, and it encourages but does not require the Small Business Concern to partner with a research institution.
- No more than $225,000 in total costs in any SBIR or STTR Phase 1 application can be requested.
- For eligibility criteria that must be met at the time of award, refer to Section III, Eligibility Information, of the FOA .
- All applications must be submitted electronically through Grants.gov.
- Applicant organizations must complete essential registrations prior to submitting an application: (1) the System for Award Management (SAM), (2) the U.S. Small Business Administration (SBA) Company Registry, (3) Grants.gov, (4) Electronic Research Administration (eRA Commons), and (5) Dun & Bradstreet Universal Numerical System (DUNS). Grants.gov will not accept applications from organizations that do not have these registrations.
- Projects with high interest for consideration are technologies that will make a large impact in the natural products field. Specifically, priority will be given to technologies that will widely benefit a majority or significant number of natural products scientists.
- Projects that are not applicable to this solicitation are projects that have a small audience, synthesis of analogs, and construction of libraries of compounds, microorganisms, and/or plants, and collection of natural products or storage mechanisms.
Process of Reviewing SBIR-STTR Grant Applications
NCCAM will create a special emphasis panel (SEP) to review applications. The composition of the panel will reflect the nature of the applications received. Cover letters should include a description of the applicant’s and the primary investigator’s expertise. Please DO NOT recommend potential reviewers BY NAME or institution. The date and review platform have not yet been determined.
- Applications: should address the review criteria in the FOA; should be easy to read; and should be organized so that it is easy for reviewers to find information.
- The review criteria for SBIR/STTR FOAs are almost identical to the review criteria for a standard NIH research grant. One unique criterion appears under the Significance criterion: “Does the proposed project have commercial potential to lead to a marketable product, process, or service?”
- The composition of the review panel will be a reflection of the science proposed in the applications NCCAM receives. Consequently, the experience of the panel may be broad. All reviewers will provide scores for all applications with which they are not in conflict. This means that an application should be written so that it can be understood by someone who is not an expert in your field(s).
- Follow the page limits laid out in the FOAs. Appendix materials are not accepted for these FOAs.
Teleconference Participants’ Questions and Answers
- Question: Will these two RFAs welcome grants to modify the natural products by one or two steps to enhance their efficacy in prevention and treatment of cancer?
- Answer: No, is the short answer. That is really a little bit out of bounds of what we are seeking in this FOA. I assume this is meaning to create new analogs for increasing activity or delivery or something like this, and honestly, that is not what NCCAM is looking for. That previous example is really development not of a technology but of a pharmaceutical agent. Thus, those are really not the types of projects NCCAM is interested in funding. NCCAM is interested in funding technologies that are going to drive natural products research.
- Question: What are the special review criteria and how will they influence the review process?
Please refer to Section 5, “Application Review Information.” Under Scored Review Criteria, the first criterion is called Significance. Beneath that, is a short paragraph. The review question that is unique to the SBIR and STTR is, “Does the proposed project have commercial potential to lead to a marketable product, process, or service?”
How is this going to be addressed in review? This is one question in one of the five standard review criteria that reviewers will use in assessing your application. It is one of the factors that reviewers will assess in developing a criterion score for the Significance criterion. Reviewers will develop criterion scores for each of the five scored criteria. These scores will help guide the reviewer in determining an overall impact score. The overall impact score is not an average of the individual criterion scores; reviewers are allowed to weigh the individual criteria as they see fit. For example, if an applicant proposes a project that is scientifically very weak, but it's coming from an outstanding lab with outstanding resources and staff, reviewers may give greater weight to the strong environment and staff. On the other hand, another reviewer might determine that these are really good investigators at a really good institution, but the approach they are proposing is fatally flawed. So that reviewer may place a greater emphasis on the approach criteria. So again, individual reviewers are allowed to evaluate and weigh the criteria as they deem appropriate. It is not uncommon for all of the reviewers to agree on all of the strengths and weaknesses for the entire application. However, individual reviewers will weigh the various criteria differently, and can sometimes come up with different overall impact scores.
- Question: Do you have the bar on what should be the score in order to get funded?
- Answer: We really can't say that a particular number would be associated with a funding level or not. We just don't know until the review process is complete.
- Question: Should the examples and proof of concepts that we provide be more geared to health care, or should it be general, like food industry, cosmetics, and other things?
- Answer: Definitely health care. In fact, I cannot second guess the reviewers, but if a reviewer felt that it was applicable more towards, for example, the food industry, they may conclude that the work doesn't seem to fit the mission of NIH, which is health research. Moreover, all Federal agencies that offer grants of any significant size have the SBIR/STTR program, so food would fall under the United States Department of Agriculture (USDA), who I am confident has these programs, as do a variety of different Federal agencies. For NIH, definitely emphasize the health care aspect. Please review the review criteria for this FOA under “significance”…“If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved”? The National Institutes of Health focuses on the health of the Nation, and one way of improving the health of the Nation is through basic biomedical research.
- Question: How many applicants are there, and how many will get funded?
- Answer: I cannot answer either of those questions. Both questions fall under rules of confidentiality. In fact, this is not information that we have at this point. The application deadline for this FOA is August 2, 2013, so applications have not been received yet. We have some indication of the number of letters of intent that were received; however, this was not mandatory. But providing you the number of applications received is prohibited by law.
- Question: First, clarify the application due date. According to the announcement, the next application date is August 2nd, which is not too long from now. I know for STTR or SBIR, normally there is a December due date, and usually a beginning of the year application date. So, I just wanted to find out whether for this FOA, the December or beginning of next year application date qualifies?
- Answer: Refer to the first section of the FOA; the application due date is August 2, 2013, by 5 p.m. local time of the applicant organization. It does not have future dates. Now, that does not prohibit applicants from coming into the general FOA in December or in January of 2014, but if you wanted to apply for either of these FOAs, you should submit your application by or before August 2, 2013.
- Question: I thought I heard earlier that at this point only Phase 1 is called for but next year there will be both Phase 1 and Phase 2. So, I was thinking that perhaps this same FOA will be reactivated next year to allow those who might be more interested to develop their methodology and have preliminary results, feasibility testing and perhaps apply later than the August 2 deadline, which is very soon.
- Answer: There may be another initiative next year. However, there are no guarantees and no promises. If there is an initiative next year, we cannot speculate what the due date will be. For now, there is only one receipt date for this RFA as it is for most RFAs.
- Question: Are we allowed to list conflicts of interest in the cover letter?
- Answer: Yes. If you think that a particular person is going to be in conflict with your application, you can state that in your cover letter. Please provide the name of the person and their institution, and please also provide a reason why you think they are in conflict. In the past there have been applicants who have tried to claim entire departments or anybody who ever worked with a particular person in a particular department to be in conflict. These types of conflicts are not well received. Please provide very specific and discrete lists of people who you think are in conflict. You will probably be contacted by a Scientific Review Officer (SRO) in order to clarify and provide more information about the nature of the conflict.
- Question: Are there specific classes of “nuisance” compounds that you would like to target for removal from the natural products by the technology to be developed?
- Answer: Sure, there are certain classes of natural products that are notoriously problematic when doing certain types of screening, most notably tannins. There are existing technologies to remove tannins, but there may be other innovative ways to do this more efficiently; also certain complex sort of carbohydrates can be messy nuisances. Certain other kinds of compounds just are things you don't want in a particular sample. For example, if there is a particular plant that has a toxic component to it, and this is going to vary from plant to plant, of course—but if you wanted to remove that such as with ginkgo and ginkgolic acid. Ginkgolic acid is many times considered a nuisance compound, because it is associated with toxicity. If you had a very novel methodology that could selectively remove ginkgolic acid, for example, then that would be attractive as well. Yes, I think this could be looked at as part of a de-replication process as well—known compounds that are pretty common, that in a sense become nuisances because they're things that you don't want to re-isolate each time.
- Question: Will applications seeking to develop a multiplex bioassay to explore drug-natural product interactions be of interest?
- Answer: Yes. Natural product drug interactions are an area of high interest to NCCAM. Also, if there was a technology that could address that in innovative ways, then that would be of interest to NCCAM. Drug interactions and, obviously, novel assays are of high interest and would be well received at NCCAM. If you have specific questions of this nature about your proposed project, please direct them to Dr. Williamson, by e-mail at: firstname.lastname@example.org.
- Question: Is it allowable to include aims to create informatics tools for data management and data interpretation as a component of new technology development, specifically, creation of an automated data pipeline for providing results to future clients?
- Answer: I would need more information about specifics to provide a substantial answer to that question. I would hate to turn someone away; however, the informatics and databases of products are not something we are interested in with this FOA—unless this technology can be broadly applied and widely disseminated to impact the natural products field.
- Question: Does this FOA allow the isolation of two or three or four or five compounds which have a lot of biological equity, or it has to be more than that?
- Answer: NCCAM is looking for things that a very general natural product scientist would look at and say, wow, that’s something I really need to be able to do, and not just a handful of natural products chemists working in a specific area, but something that covers a broad area. One of the ways I try to have people think about it is: think the idea that whatever you are proposing to do is going to wind up as a small package, and it should be a package that you want to sell to people. And that package—in a sense, you need to sell it to a lot of people to make money on your package. So, propose projects that you could sell to a large crowd of natural product scientists, and not just one with a specific area that only, you know, a few natural products scientists would really be interested in. In addition, NCCAM is not interested in the isolation of your compound, or projects where the focus is really the development of a compound. We are interested in new tools that are of broad applicability. We are looking for people to develop the equivalent of pliers for natural products so that anybody that’s working in the natural products field would want to have that tool.
- Question: Suppose somebody comes with a natural product which has not been tested for certain biological function, and then our data shows, wow, my God, this is something novel. So what do we do about it?
- Answer: That is still drug discovery and drug development. You are not developing a tool, you’re developing a product. No matter how exciting the activity of that product is, it is not a method or a tool.
- Question: We are developing a technology also, isolation of that product from natural things, because we found an interesting observation in a series of compounds that can be isolated from natural product, and tested for a particular function. I can write you a letter with details, and you can tell me whether it fits or not, before I make the effort to write a proposal.
- Answer: Yes, please e-mail me (Dr. John Williamson) and with a little more information and we can make a better judgment. My e-mail address is at the bottom of the FOA under “programmatic contact.”
- Question: Is NCCAM open for combination drugs too? Perhaps, natural products in combination with other drugs and molecules for a more synergistic efficacy?
- Answer: Of course NCCAM is interested in that, but again, you would have to explain to us what the tool is you’re looking at and the methodology in a clear and compelling way.
- Question: Is NCCAM interested in the pathways involved, like what pathways are taken up by what natural products? Or are you interested in the big picture of these natural products’ role or their usefulness?
- Answer: Yes, NCCAM is interested in pathways. But again, we are looking for tools. And the pathways that we would be interested in would be common pathways in natural products science. Think along the lines of what is the tool, and when you’re proposing, state that it is a new technological tool to help natural products in a very broad sense.
- Question: We are using natural molecules to create nanoparticles of other drugs. How important is preliminary data and will applications that lack preliminary data be considered?
- Answer: No, you do not really need preliminary data for that idea. Phase 1s are more based on development of an idea. So you don’t necessarily have to have a lot of preliminary data. But something to back up your hypothesis, you know, so that it’s, you know, helpful for us to say this is a reasonable approach to gaining a tool. So from a review perspective, reviewers always like to see preliminary data. It demonstrates that what you’re proposing is feasible and provides some justification to suggest that your hypothesis is going to work. However, if you do not have preliminary data, your application is not necessarily going to fail, but rather, preliminary data is always helpful.
- Question: We have discovered some natural molecules which can be used to create nanoparticles like liposome and other things. Does it fit in this kind of grant at this particular time? This is a new discovery which has never been reported.
- Answer: No, is the short answer. That is more of a delivery system that you would be talking about. You are proposing creating liposomes out of natural products. For specifics, e-mail me your idea. Direct it towards, “here is my tool.” If you can e-mail it that way, we will take a look at it and provide feedback.
- Question: I was just listening that you are looking for a common technology which can be used by multiple scientists. So this new discovery, what we have discovered, we have already used on 87 drugs, to create nanomolecules. It’s a common platform which can be used on any—whether it’s a natural or non-natural molecule. We have used it on 15 natural molecules.
- Answer: Now remember, we are looking for things that not will help other scientists, but will help natural product scientists. If you would like more information on the topic, e-mail your question to: email@example.com.
- Question: Please elaborate on Objective 3, especially the phrase, bioassays including capability to identify potential synergistic mechanisms.
- Answer: We are interested in assay technologies that will look at multi-modal research ideas—assays that might give us an idea of potential interactions, and those that look within a system to see if more than one natural product is working to create bioactivity whether they’re working together to do that, versus just one molecule itself.
- Question: How does the companion funding work? Can one apply to both?
- Answer: Absolutely! I will just add that there are slight variations in terms of the structure. You cannot have the same purpose and same design for both. You could have different applications going to both, but you can’t submit the same application to both. So to clarify, you can submit it, but one of the applications will be kicked out. By NIH policy, you can only have one application on the same science to review by any component of the NIH at the same point in time. Thus, you can submit more than one application but it has to be different in the two applications.
- Question: Less than 33 percent of the SBIR may be carried out as consortium/contractual arrangements. My question concerns how to best structure this if the collaboration is with an academic lab, especially for the purpose of the budget. If the academic lab has specialist equipment that the company needs access to in order to complete the proposed SBIR work, is it possible to structure this as a simple hiring of lab equipment; i.e., the contract covers consumables and a fee for hired time on the machine but the company personnel run the samples and analyze the data themselves? Or is it more favorable for a contractual agreement to be structured as more of an intellectual collaboration so that as well as the use of specialist equipment it also brings expertise, and operation of the specialist equipment is carried out by personnel from the academic lab?
- Answer: If you are only paying for access to equipment, and personnel from your company will be running the experiment, I would not consider that a collaboration. As such, I don’t think it would count as part of the 33 percent. However, if you really need the intellectual input of the academic lab personnel in order to properly set up, acquire, and interpret the data then it would be better to set this up as collaboration. In this case it would be part of the 33 percent.
- Question: Can you provide advice as to what proportion of the SBIR grant is reasonable to commit to salary? For example, if the grant were to cover two researchers committing greater than 50 percent time to work on the Phase I SBIR this could be a nominal $80,000 or 35 percent of the total award amount ($225,000) going to salary. Is this a reasonable ballpark?
- Answer: As with any other type of research, the largest expense for an SBIR project is often personnel. Therefore, it is appropriate to include salary costs for key personnel in your application. Obviously, the salary requested should be commensurate with the level of effort on the project and also should be calculated in the context of how best to achieve the overall objectives of the research.
- Question: Equipment is itemized in section C of the budget but only if it exceeds $5,000. How should items that fall under the heading “equipment” (i.e., service life of more than 1 year) but which cost less than $5,000 be included in the budget? Should these be listed in section (F) Other Direct Costs?
- Answer: Small equipment can be listed in the budget under materials and supplies. However, if it is a substantial cost you might want to call it by name so the reviewers can see that you will have what you need for a successful completion of the project.
Programmatic Questions Contact:John Williamson, Ph.D.
Division of Extramural Research
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard II, Suite 401
Bethesda, MD 20892 (Courier Service - 20817)
Review Questions Contact:Dale Birkle Dreer, Ph.D.
Chief, Office of Scientific Review
Division of Extramural Activities
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard II, Suite 401
Bethesda, MD 20892 (Courier Service - 20817)
Tel: (301) 451-6570
Fax: (301) 480-2419