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Frequently Asked Questions

Protein Capture Initiatives: RFA-RM-10-017 and RFA-RM-10-018

FAQs From Pre-Application RFA Teleconference (Dec. 17, 2010)

  1. Are there sources other than the transcription factor (TF) production program that will supply protein for affinity reagent development?
  2. At the workshop, there was some discussion of targeting specific areas or all proteins in general. Question – is there an interest in developing reagents targeting specific types of proteins?
  3. Can you address the possible need to purchase significant infrastructure in the first year? What is the budget flexibility for such purchases?
  4. For the technology RFA-018, if we focus on reducing the cost of producing affinity reagents and improving validation, do we also need to propose a scalable and cheap way to generate the antigens if they are recombinant proteins?
  5. The RFAs talk about providing the reagents to the research community with no intellectual property (IP) constraints. Does this refer to minimal constraints to use them for research or minimal constraints to use them for research and in any other future application like a diagnostic if the reagent is found to be useful in such an application?
  6. The RFAs talk about providing the reagents to the research community at reasonable cost. Does this mean at customary market prices for capture reagents such as monoclonal antibodies (MAbs)?
  7. Regarding the points:

    Does this mean the affinity reagent should have a minimum of 2 applications, or 4 applications (immunohistochemistry, immunofluorescence, immunoprecipitation plus one more)?

  8. Could you please comment on whether our proposal to develop a pipeline for generating epitope-tagged human cell lines is responsive to the RFA?
  9. May I apply from an institution based outside the U.S.?
  10. In addition to above, are there any stipulations or biases for the inclusion of a U.S.- based investigator in the application?
  11. What if I have existing funding for a similar effort? Will this be viewed as a positive, negative, or neutral?
  12. Can I submit an update to my application before the review?
  13. When will the review be held?

General to both RFA's:

  1. What is the main intent of the Protein Capture Program?
  2. How was the program initiated and planned?
  3. How will the FOAs be reviewed?
  4. What is the difference between the two FOA’s?
  5. What is the difference between the Resource Distribution Plan and the Resource Sharing Plan?
  6. In writing the application, how do I construct the Resource Distribution Plan?
  7. Why does NIH need to discourage Intellectual Properties on these reagents?
  8. What is the U54 (cooperative agreement) mechanism and why are these Centers/Programs being funded as U54s?
  9. Are foreign scientists and institutions eligible?
  10. Do I need to submit the application via paper format?
  11. Can an applicant institution submit applications to both FOAs?
  12. Can these centers be a multi PI centers and who should be the administrative contact in this case?
  13. Can we ask for equipment and are vendor quotes necessary?
  14. What is the deadline for a letter of intent and is it required?

For RFA RM-10-017:

  1. How do I structure the application?
  2. Even if there could be two awards made for this FOA, can we still ask for the whole amount of funds available? What happens if we do, and you decide to make two awards?
  3. We have an alternate method (or way of doing some component of the pipeline) that we would like to try out alongside our production pipeline. Can we do this? How?
  4. We have a new way of doing this that is not anticipated in the way the RFA was written (e.g., uses different pipeline steps, combines pipeline steps, etc.). Can we apply?
  5. How do we obtain immunogens?
  6. I am part of a consortium that already does this (eg, for a different class of proteins, or a different end-use), and parts of this could be done by my colleagues. Can I organize this to distribute the project over the consortium? Similarly, can investigators for the Center be located at different institutions?
  7. I already have a pipeline developed, and at least one component of that is already partly or completely funded. How do I deal with this in my application?
  8. What is the total budget cap and per year cap? Can I ask for less than 5 years?
  9. Is this RFA expected to be reissued after 5 years?
  10. What are the time constraints for distributing the reagents that I might produce within my project?
  11. Who are the contacts if I have additional questions?

For RFA RM-10-018:

  1. Does this FOA aim to develop a production pipeline?
  2. How should the application be structured and what are the page limits?
  3. Are development of validation methods and production of antigens solicited within this FOA?
  4. Is there a bias toward any specific technology or approach?
  5. What is the budget cap and maximum length for proposal submitted in response to this FOA?
  6. What is going to happen after this 3-Year award?
  7. Can I patent any new technology that I will develop within this FOA?
  8. How do we obtain immunogens if needed within the proposed approach?
  9. What are the time constraints for distributing the reagents that I might produce within my project?
  10. Who are the contacts if I have additional questions?

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FAQs From Pre-Application RFA Teleconference (Dec. 17, 2010)

  1. Are there sources other than the transcription factor (TF) production program that will supply protein for affinity reagent development?
    For RFA-017, NIH Program has considerable interest in coordinating efforts between a TF supplier and the TF affinity reagent center(s) funded by this RFA. We encourage the use of the existing U54 center which is a part of the Protein Capture Reagents Program, but we recognize it may be advantageous to cultivate other sources of TF targets. Thus, applicants may propose alternative sources, as long as they are well-justified.

    Applicants should review the information available on the Common Fund Web site regarding the antigen production component (http://nihroadmap.nih.gov/proteincapture/fundedresearch.asp).

    For RFA-018, any well-justified source of antigen may be proposed - and will need to be proposed if the application will develop reagents against human proteins that are not transcription factors.
     

  2. At the workshop, there was some discussion of targeting specific areas or all proteins in general. Question--is there an interest in developing reagents targeting specific types of proteins?
    RFA-017 is clearly for developing reagents targeting human transcription factors. For RM-10-018, the focus is not to develop reagents for targeting specific protein types (subproteome), but to develop technology which can be integrated into a reagent production pipeline for producing reagents against a broad array of protein types. The technology can potentially target a subproteome, but there has to be an argument why it is significant. For example, the subset may be less tractable by other means; in other words may require a specialized production approach. Or, the subset should represent a good test set that could provide evidence that the approach to be developed is capable of dealing with the proteome as a whole. Again, the more important issue to address, is the technology needs to be integrated into some kind of production (even if not high throughput) within the period of the award.
     
  3. Can you address the possible need to purchase significant infrastructure in the first year? What is the budget flexibility for such purchases?
    For RFA-017, there is no specific cap on equipment purchases.

    For RFA-018, the direct cap on equipment purchases is $1M.

    For both, NIH program staff is aware that substantial infrastructure purchases may be necessary early in the award. Applicants proposing to purchase significant equipment should be aware that this must be done within the overall award budget, and are encouraged to explore efficient mechanisms for smoothing major equipment costs, considering the risks of purchasing equipment and changes that may occur in technology. Some potential options for doing so include leasing, institute cost-sharing, or sharing with other funded efforts (for example, where an instrument will be used less than 50% for this effort). Keep in mind that large ticket items are often scrutinized by reviewers, so these should be carefully justified.
     

  4. For the technology RFA-018, if we focus on reducing the cost of producing affinity reagents and improving validation, do we also need to propose a scalable and cheap way to generate the antigens if they are recombinant proteins?
    No. However, your plan should include a justification of why such antigens were chosen in the context of an overall production pipeline.
     
  5. The RFAs talk about providing the reagents to the research community with no intellectual property (IP) constraints. Does this refer to minimal constraints to use them for research or minimal constraints to use them for research and in any other future application like a diagnostic if the reagent is found to be useful in such an application?
    The brief answer is that the program intends to develop a community resource. As such we expect that there will be minimal constraints on the reagents, constraints that could unduly inhibit the use of the reagents by the community. For example, high costs could inhibit downstream high-throughput or multiplexed applications. Excessive IP could inhibit adding additional value to elements of the resource. The RFA asks applicants to propose a distribution mechanism that is compatible with both private and non-profit distribution. There are other reasonable models as well, for example models that include distribution of the resource through a public repository, and also distribution for profit of a resource with value added for example that was not funded by the grant. (In the case of antibodies, this could include for example labels, secondary reagents, kits, improved user support, and so on.)

    The RFA asks applicants to describe their distribution plans, and their plans for IP, if any. The reviewers will assess these plans against the goals of the RFA, including the goal of having a useful community resource as above. The practical aspects of the distribution plan (for example, has it been adequately planned for, budgeted, staffed, will reagents actually get into the hands of the community, will reagents be adequately quality controlled, or QC’d, in distribution, and so on) will be considered as part of the score. The reviewers will comment on, but not score, other aspects of the distribution plan, for example the IP plans.
     

  6. The RFAs talk about providing the reagents to the research community at reasonable cost. Does this mean at customary market prices for capture reagents such as monoclonal antibodies (MAbs)?
    As stated in the production RFA, we expect that the distribution plan will be compatible with multiple mechanisms of distribution (for profit, non-profit) in order to realize the goals of creating a community resource. Thus, a private entity may set prices for its own distribution (for example if the company adds additional value to the resource). However it is expected that the resource will also be distributable by a non-profit mechanism (for example through the Iowa Developmental Studies Hybridoma Bank, for hybridomas; http://dshb.biology.uiowa.edu/) which is likely to have low prices. More generally, low costs are important for downstream utility, for example when considering high-throughput or multiplexed applications, and are thus encouraged. General consistency with goals pertaining to the utility of the resource will be assessed by the reviewers.
     
  7. Regarding the points:
    • Broadest possible utility (e.g. immunohistochemistry, immunofluorescence, immunoprecipitation)
    • At least one specific application in addition to above (not just WB)

    Does this mean the affinity reagent should have a minimum of 2 applications, or 4 applications (immunohistochemistry, immunofluorescence, immunoprecipitation plus one more)?
    We are soliciting for technology development that can be paired with as many applications/methods as possible. Currently, there are certain technology approaches that work best for certain methods. We discourage the use of only WB (Western Blot) since this method is viewed as the simplest. A proposal would be strengthened to encompass broader utility. We particularly encourage, at a minimum, a technology which is compatible with characterizing both specificity and affinity for validation purposes, for example, assessing both specificity and affinity with two separate methods (i.e. titration curves in IP for assessing affinity, and WB for specificity).
     

  8. Could you please comment on whether our proposal to develop a pipeline for generating epitope-tagged human cell lines is responsive to the RFA?
    No, this is not considered responsive. While this could be a very useful resource for some applications (for example, it may ultimately be an excellent approach to systematically elucidate protein-protein interactions), these particular solicitations focus on protein capture reagents that can be useable in a number of contexts.
     
  9. May I apply from an institution based outside the U.S.?
    Yes, with some conditions. For example, non-U.S. grant applications must demonstrate unique strengths or capabilities not readily obtained in the US. This will be commented on by reviewers and considered during the funding decision (though it will not enter into the actual review scoring). In addition, F&A (“indirect”) costs are limited to 8% of direct. See http://grants.nih.gov/grants/foreign/
     
  10. In addition to above, are there any stipulations or biases for the inclusion of a U.S.- based investigator in the application?
    No, there are no stipulations/biases for inclusion of a U.S.-based investigator. Again, foreign applicants should emphasize what unique strengths they bring to leading such an effort versus a U.S.-based investigator, but there is no partiality for involving U.S. investigators.
     
  11. What if I have existing funding for a similar effort? Will this be viewed as a positive, negative, or neutral?
    NIH policy is such that you cannot ask for money to do the same thing funded by other means. However having two projects with an overlapping scope is permissible as long as there is not actual duplication. Minor overlap can be addressed administratively (for example, by negotiating an award budget to ensure that overlap is minimized). Existing funding is not a specific advantage, nor a detriment. However, in general we expect that the most competitive applicants will leverage their existing R&D knowledge, infrastructure, and capabilities gained through many funding resources, and the quality of the research environment will be evaluated by reviewers.
     
  12. Can I submit an update to my application before the review?
    Yes, with the following limits:
    1. All additional (post-submission) materials/updates must be submitted 30 days prior to the review date.
    2. Page limits for updates are: five pages for the Production RFA (RM-10-017), and four pages for the Development RFA (RM-10-018). (In general, NIH policy is that for each section of the research plan for a "U" award, applicants may submit additional information: 1 page for each 6 page section, 2 for each section up to a page limit of 12 pages, and for each 30 page section, they can submit a 3-page update.) 3. Updated Specific Aims or Research Strategy pages, late-breaking research findings and new letters of support or collaboration will be allowed within the page limit.
  13. When will the review be held?
    It has not been scheduled yet, but is most likely to take place in June or July. The review dates will be available via the Common Fund’s Protein Capture program web site as soon as they become publicly available. For other information please contact the Scientific Review Officer listed in the RFA.
     

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General Questions

  1. What is the main intent of the Protein Capture Program?
    The Common Fund Protein Capture Reagents program seeks over the long term to establish a renewable resource of protein capture reagents specifically designed to meet biomedical research demands. Initially, the program seeks to develop renewable affinity reagents against human transcription factors (TF). At the same time, the program will explore improvements in the ability to produce renewable affinity reagents, for example with regard to quality, utility, throughput, cost, and production scalability, so that the long-term goal of producing renewable reagents to the entire human proteome can be realized.
     
  2. How was the program initiated and planned?
    The Protein Capture initiative was planned and initiated through the NIH Common Fund (http://commonfund.nih.gov) based on discussions begun more than five years ago. Those discussions established a clear need, but some significant practical questions were raised: First, are there any technologies available that could efficiently, and with reasonable cost, yield a resource of renewable capture reagents? Second, what are the prospects for improvements in production, and how long should NIH wait for these to initiate a project? Based on these questions, and the fact that the basic need for such a resource remained high, in the last eighteen months, a decision was made to go forward with a pilot project to produce protein affinity reagents for an important sub-proteome (human TF's), and at the same time to encourage development of alternate approaches that may offer improvements in the ability to scale to the entire human proteome. The NIH Common Fund approved the Protein Capture Reagents program in late 2009.

    The program is being implemented in phases, with three Funding Opportunity Announcements (FOA’s):

    FOA 1: Antigen Production — To produce human transcription factor antigens for making monoclonal antibodies; this effort has already been funded.

    FAO 2: Anti-Transcription Factor Antibodies Production — To optimize and scale anti-transcription factor capture reagent production to develop a community antibody resource.

    FOA 3: New Reagent Technology Development and Piloting — To develop new technologies to improve cost, scale and utility of reagent production pipeline.

  3. How will the FOAs be reviewed?
    Applications for both new FOAs will be peer-reviewed for scientific and technical merit by a Scientific Review Group convened by the Center for Scientific Review working closely with the Common Fund program. Those applications deemed to have the highest scientific and technical merit, will be discussed and assigned an overall impact/priority score, and receive a written critique.

    Following initial peer review, recommended applications will receive a second level of review by the appropriate National Advisory Council or Board. The following will be considered in making funding decisions:

    • Scientific and technical merits of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
  4. What is the difference between the two FOA’s?
    The main distinction is that the "production FOA", RFA-RM-10-017, focuses on TF capture reagent production using technologies that are "ready to go" in a large-scale production effort. The "development FOA", RFA-RM-10-018, focuses on development of early-stage approaches and maturing them over the next 3 years to bring them online for large-scale efforts.
     
  5. What is the difference between the Resource Distribution Plan and the Resource Sharing Plan?
    It is NIH policy that the results and accomplishments of the activities that it funds should be made available to the public. PIs and funding recipient institutions are expected to make the results and accomplishments of their activities available to the research community and to the public at large. See NIH policies and related guidance on sharing of research resources at the link: http://grants.nih.gov/grants/sharing.htm.

    The NIH sharing policy has general requirements that apply to most NIH grant applications and also some specific requirements that apply to all applications requesting more than $500,000 in any given year. A Resource Sharing Plan should address all the requirements indicated in the PHS398 Application Guide. These include a Data Sharing Plan, a Sharing Model Organisms, and Genome Wide Association Studies (GWAS) when needed. For this specific FOA we are requesting also a Resource Distribution Plan for addressing the main goal of generating a broadly-accessible community resource. The detail requirements for the Resource Distribution Plan are reported below and in the FOA. There is some overlap between the requirements stated in the Resource Distribution Plan and in the Resource Sharing Plan. For avoiding duplication we recommend that when feasible you reference the Resource Distribution Plan and do not duplicate the information in the two plans.
     

  6. In writing the application, how do I construct the Resource Distribution Plan?
    The Plan must be consistent with the discussion in the FOA section "Scientific Knowledge to be Achieved". Applicants must include discussion of:
    • Availability of the reagents;
    • Availability of information about the reagents (validation, characterization data);
    • Availability of protocols for validations/characterization;
    • Availability of any software tools developed for this award using NIH funds;
    • How any intellectual property will be managed.

    Additional points to consider when constructing the Plan: The applicant must propose a viable resource distribution plan to ensure that reagents can be obtained by the community. There are several potential (and non-mutually exclusive) ways that this could be done; for example reagents could be sent to a public repository (if one exists for the type of reagents the applicant is proposing to produce), or reagents could be distributed through a collaboration or partnership with a public or private entity that has the expertise to do so. The main constraint on this is that the plan for distribution must be consistent with making the reagents available to the research community without excessive cost, and without licensing or other restrictions that could prevent either downstream use, or alternate means of distribution.
     

  7. Why does NIH need to discourage Intellectual Properties on these reagents?
    It is intended that the reagents be widely available for a broad use. Accordingly, awardees will be expected to manage intellectual property in a way that is consistent with achieving the goals of the FOAs and in accordance with applicable NIH guidelines and best practices.
     
  8. What is the U54 (cooperative agreement) mechanism and why are these Centers/Programs being funded as U54s?
    A U54 support mechanism is used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

    These awards will be funded as Cooperative Agreements for two reasons. The first is that NIH expects to have closed involvement in these projects in order to understand the state of the art, and opportunities for process improvement as they arise. NIH program directors will need to assess the success of these efforts in two contexts-first to ensure that production goals are being reasonably met, and second to assess whether the pilot has been successful to the extent to merit a future expansion of the program.

    The second reason is that the awardees for the three FOAs will operate in the context of a research network, specifically with regard to the setting of common standards and metrics (production, quality) so that progress can be reasonably assessed, and because the antigen production effort is likely to need to interface closely with at least the affinity reagent production effort. Moreover, NIH staff expects that in general, scientific interactions between awardees will make overall project more productive.
     

  9. Are foreign scientists and institutions eligible?
    Yes. Reviewers will help NIH assess whether an application from a non-US investigator offers unique capabilities that could not readily be available from a US investigator. This assessment will be used in the funding decision, but will not itself be factored into the scoring of the application.

    NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260 (policies on foreign institutions are listed near the bottom of the page). "In general, foreign institutions and international organizations, including public or private, non-profit or for-profit organizations, are eligible to apply for research project grants
     

  10. Do I need to submit the application via paper format?
    Yes. An original and 5 copies needs to be mailed to NIH as per the PHS398 Application Guide.
     
  11. Can an applicant institution submit applications to both FOAs?
    Yes.
     
  12. Can these centers be a multi PI centers and who should be the administrative contact in this case?
    Yes. If the project will benefit from a collaborative approach, multi-PD/PIs are allowable as long as the investigators have complementary and integrated expertise; and if their leadership approach, governance and organizational structure are appropriate for the project (see http://grants.nih.gov/grants/multi_pi/ for additional details).
     
  13. Can we ask for equipment and are vendor quotes necessary?
    Equipment can be requested and quotes are not necessary at the time of the submission. However, it is expected that the investigator will do a diligent work in evaluating the cost of the equipment requested in consultation with the appropriate vendors. If a piece of equipment is not meant to be used in full within the proposed project, and other uses are intended outside of this project, it is expected that only a portion of the cost will be requested.
     
  14. What is the deadline for a letter of intent and is it required?
    The deadline is January 4, 2011. 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.
     

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For RFA RM-10-017:

  1. How do I structure the application?
    The application instructions allow applicants three sections for their overall research plan: a 30 page section to describe and justify the research strategy (including the elements of production e.g. from receipt of antigens through validation); a 6-page section describing distribution plans; and a 6 page section describing how the effort will be managed.
     
  2. Even if there could be two awards made for this FOA, can we still ask for the whole amount of funds available? What happens if we do, and you decide to make two awards?
    Yes, a single applicant may request the entire amount available ($20M over five years, total costs). The applicant must of course carefully justify the request in the application. If NIH decides to consider making two awards (this will be highly dependent on the quality of the applications as judged in review), NIH will request information from the applicants on the effects of a reduced award, prior to making a final funding decision.
     
  3. We have an alternate method (or way of doing some component of the pipeline) that we would like to try out alongside our production pipeline. Can we do this? How?
    Applications should focus on production. Applicants may propose to test incremental improvements to their production pipelines during the term of the award that can provide measurable improvements to production during the life of the award. Applicants wishing to propose pursuing very significant or stand-alone improvements that will require significant resources (for example, which is likely to significantly detract from the important goal of producing reagents against all or most human transcription factors) should consider applying to the other FOA (RM-10-018). If you are unsure, please contact the Program Contact for this FOA.
     
  4. We have a new way of doing this that is not anticipated in the way the RFA was written (e.g., uses different pipeline steps, combines pipeline steps, etc.). Can we apply?
    This FOA firmly emphasizes the use of mature technologies for pipeline production. The application must justify that the approach is ready for scaling to production. It is possible that applications will propose a pipeline that is somewhat different (for example, has different steps, or integrates steps in a way that does not appear to be anticipated by the FOA). If so applicants should be careful to justify the approach in terms that can be compared to other approaches.
     
  5. How do we obtain immunogens?
    Center(s) funded under this production RFA will identify, prioritize, and acquire all required transcription factor immunogens, in collaboration with other components of the program (specifically, the Antigen Production group already funded; http://nihroadmap.nih.gov/proteincapture/fundedresearch.asp). Developing a supply of immunogens ahead of the development of an affinity reagent production pipeline has advantages, but will require additional coordination once the research under this FOA has begun.
     
  6. I am part of a consortium that already does this (eg, for a different class of proteins, or a different end-use), and parts of this could be done by my colleagues. Can I organize this to distribute the project over the consortium? Similarly, can investigators for the Center be located at different institutions?
    Yes to both. This will place additional stress on the management plan for the center, which should be carefully described in the application.
     
  7. I already have a pipeline developed, and at least one component of that is already partly or completely funded. How do I deal with this in my application?
    It is acceptable to incorporate a component that is funded by other means into the application. The component should still be described, and its approach justified in the overall context of the center. Sources of complimentary funding should be clearly identified.
     
  8. What is the total budget cap and per year cap? Can I ask for less than 5 years?
    Individual application budgets should not exceed $13M or $2.6M per year, direct costs (there is a total of $20M or $4 M per year available for this FOA) and must reflect actual needs of proposed project. Applicants can ask for less than 5 years if production of the full set of TF capture reagents is anticipated to take less time.
     
  9. Is this RFA expected to be reissued after 5 years?
    This is unlikely. This is considered a pilot program which will inform NIH program staff on how and whether to launch a larger production effort to develop affinity reagents for the entire human proteome.
     
  10. What are the time constraints for distributing the reagents that I might produce within my project?
    Reagents should be readily available for research purposes to qualified individuals within the scientific community within a reasonable time after they are each produced and validated. It can be expected that the Research Network will establish more formal policies once information is available about realistic production expectations. All reagents should be available by the end of the 5-year funding period.
     
  11. Who are the contacts if I have additional questions?
    For scientific and main questions on the FOA the contact is Dr. Adam Felsenfeld (adam.felsenfeld@nih.gov). For questions related to the study section and Peer Review prior to the review meeting the main contact is Dr. Joseph D. Mosca (MoscaJos@CSR.NIH.GOV).
     

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For RFA RM-10-018:

  1. Does this FOA aim to develop a production pipeline?
    Although the production of protein capture reagents is not the main goal of this FOA the intent is that the technologies developed within this FOA are put in the context of a pipeline production. The intent is to develop approaches for production that are scalable in the near future (i.e. about 3 years).
     
  2. How should the application be structured and what are the page limits?
    The application should be organized following the instructions for PHS398 form (http://grants.nih.gov/grants/funding/phs398/phs398.html). In addition it is requested that the Research Strategy session within the Research Plan addresses: 1) Choice of targets and antigens production; 2) Renewable protein affinity reagents; 3) Characterization and validation; 4) General production information, as indicated in the session entitled "Guidance to Applicant". However, applicants are free to organize their applications differently as long as the above themes are properly addressed.

    In addition a separate Resource Distribution Plan and Management Plan are requested.

    All page limitations described in the PHS398 application guide must be followed with the exceptions that the research strategy session can be up to 30 pages and that the Resource Distribution Plan and Management Plan together can be up to 6 pages.
     

  3. Are development of validation methods and production of antigens solicited within this FOA?
    The main goal of this FOA is to improve the overall approaches for generating high quality renewable protein capture reagents. The use of antigens (when needed) and the validation of the produced protein capture reagents are part of the overall approach. Thus the brief answer is yes. However, these developments should be put in the overall pipeline approach context and should be justified within this context.
     
  4. Is there a bias toward any specific technology or approach?
    No, there is no specific technology or approach that this FOA is directed to. However, the intent is not to develop completely novel technologies but to develop technologies that have already shown proof-of-principle, while also having strong potential to increase throughput and/or substantially reduce production costs. The applications could have a major focus on one or more of the technologies used in the overall approach but the projects should be framed within a production pipeline context.
     
  5. What is the budget cap and maximum length for proposal submitted in response to this FOA?
    The maximum direct cost that can be requested per year is $1,000.000 (excluding subcontracts F&A) and up to 3 years of support can be requested.
     
  6. What is going to happen after this 3-Year award?
    The overall program is viewed as a pilot phase thus any future developments are uncertain. However, it is expected that the projects awarded within this FOA will receive a midterm evaluation in the second year. Although it is not expected that the projects can re-compete, it is possible that the overall program will develop further and that other solicitations might be published.
     
  7. Can I patent any new technology that I will develop within this FOA?
    The main intent is to reduce as much as possible any IP that would diminish the broad utilization and further development of the approaches used within this FOA. Considering also that this FOA is soliciting for technologies that have already shown proof-of-principle, it does not seem likely that new IP could be generated but perhaps previous IP could be used. It is the responsibility of the Investigators to make sure that no IP is infringed within their proposals and that the results of the project can be broadly used by the scientific community without IP that could impede or impair further development. Applicants should explain how existing IP will be consistent with the broad goals of the FOA.
     
  8. How do we obtain immunogens if needed within the proposed approach?
    The Project solicited within this FOA does not necessarily have to produce the antigens. However it is important that the selection of targets is well explained and justified. Any commercial or academic source can be used for obtaining the needed antigens.
     
  9. What are the time constraints for distributing the reagents that I might produce within my project?
    There is no specific time constraint that is in place at this stage. The long-term aim of the program is to generate a community resource so the expectation is that the reagents produced will be distributed without any undue delay after they have been validated. The NIH is likely to decide a specific policy depending on how the project develops. It is expected that the Investigators propose a Resource Distribution Plan that will be evaluated.
     
  10. Who are the contacts if I have additional questions?
    For scientific and main questions on the FOA the contact is Dr. Salvatore Sechi (sechi@nih.gov); For basic administrative questions the contact is Mr. Craig E. Bagdon (Craig.Bagdon@nih.gov); For questions related to the study section and Peer Review prior to the review meeting the main contact is Dr. Joseph D. Mosca (MoscaJos@CSR.NIH.GOV).
     

 

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