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Cooperative Research to Enable and Advance Translational Enterprises (CREATE) Frequently Asked Questions


  1. Which programs will be impacted by the changes?
  2. Will the NINDS Exploratory/Developmental Projects in Translational Research (R21) PAR-13-023 program be re-issued or redesigned?
  3. If I am applying to develop a small molecule, to which program should I apply?
  4. If I am applying to develop biologics or biotechnology products such as protein, peptide, oligonucleotide, gene and cell therapy, to which program should I apply?
  5. How many years and how much funding can I request in my CREATE Bio Discovery Track (U01 or SBIR U44) application?
  6. How many years and how much funding can I request in my Development Track of CREATE Bio (UH2/UH3, or SBIR U44) application?
  7. If I am applying to develop a device, to which program should I apply?
  8. How many years and how much funding can I request in my device application?
  9. Can past applications submitted in response to the Translational U01 program (PAR-13-022) be submitted to either the CREATE Bio Discovery or Development Track?
  10. How do the previous Translational U01 Program (PAR-13-022) relate to the programs?
  11. How does the Translational R21 compare with the new programs? What types of applications should submit to the current Translational R21 program (PAR-13-023) versus the new NIH Blueprint Neurotherapeutics Network (BPN) and CREATE programs?
  12. To what programs should small business apply?
  13. How can an investigator get guidance on how to write an application for these programs?
  14. Does an applicant have to contact NINDS before they submit?
  15. When were the new funding opportunity announcements (FOAs) released?
  16. When is the first receipt date for the new FOAs?
  17. What will be the other receipt dates?
  18. When will the first set of applications be reviewed?
  19. Where will my application be reviewed?
  20. When will the first set of applications be awarded?
  21. May foreign work be proposed in an application?
  22. Should I contact NINDS program staff if I want to apply either Discovery or Development Track?
  23. When should I contact NINDS program staff if I request $500,000 or more in direct costs in any year?
  24. How does NINDS envision encouraging the applicants to take the best therapeutics forward?
  25. Do I have to submit the structure/sequence for my therapeutic in my application?
  26. Who do we contact if we have questions?
  27. If I am interested in applying to the CREATE Bio program, what is the process?

 

1.  Which programs will be impacted by the changes?

The following announcements will be impacted by the change:

  • NINDS Cooperative Program in Translational Research (U01) PAR-13-022. Please see related cancelation notice (NOT-NS-14-013)   for PAR-13-022
  • NINDS Exploratory/Developmental Projects in Translational Research (R21) PAR-13-023
  • Advanced Neural Prosthetics Research and Development (SBIR [U44]) PAR-12-054
  • Advanced Neural Prosthetics Research and Development (U01) PAR-12-053

For the last three programs, there may be some temporary overlap in scope when the new program announcements are released.  Applicants are strongly encouraged to prepare applications under the newly announced programs when applicable and are strongly encouraged to contact program staff and also send a draft abstract for consultation.

 2.  Will the NINDS Exploratory/Developmental Projects in Translational Research (R21) PAR-13-023 program be re-issued or redesigned?

NINDS is in the process of redesigning the Translational R21 program.  There will be only one more receipt date on Oct 16, 2014 for new applications and November 16, 2014 for resubmissions in response to PAR-13-023.  New programs will be redesigned and announced after its expiration.

 3.  If I am applying to develop a small molecule, to which program should I apply?

Investigators who propose the discovery and development of small molecules should now submit applications to the NIH Blueprint Neurotherapeutics Network (BPN):  Small Molecule Drug Discovery and Development for Disorders of the Nervous System program or to the NINDS Exploratory/Developmental Projects in Translational Research (R21) (PAR-13-023). Refer to the recent notices (NOT-NS-14-020 and NOT-NS-14-021), http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm and announcements below.

 4.  If I am applying to develop a biologic or biotechnology product such as a protein, peptide, oligonucleotide, or gene and cell based therapy, to which program should I apply?

Investigators who propose the discovery and development of a biologic or biotechnology product should now submit application to the CREATE Bio program or the NINDS Exploratory/Developmental Projects in Translational Research (R21) (PAR-13-023) program. For the CREATE Bio program there will be two sets of FOAs; CREATE Bio Discovery Track and CREATE Bio Development Track:

  • The CREATE Bio Discovery Track (U01, or SBIR U44) supports the optimization of Preliminary Bioactive Agents. At the end of the funding period, projects that successfully advance through support from this program will have a Development Candidate, which has sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, and will be ready for preclinical development to enable application for an Investigational New Drug (IND).
  • The CREATE Bio Development Track (UH2/UH3 or SBIR U44) starts with a Development Candidate and supports Investigational New Drug (IND) enabling studies and their associated preparatory activities, and early clinical development. Projects must be sufficiently advanced that, at a minimum, an IND application can be submitted to the U.S. Food and Drug Administration (FDA) during the project period.  Although the program supports early clinical trials, these are not required components of proposed projects.

 5.  How many years and how much funding can I request in my CREATE Bio Discovery Track (U01 or SBIR U44) application?

  • For the U01, the proposed project period is typically 3 years and may not exceed 4 years. Application budgets are not limited but must reflect the actual needs and stage of the proposed project. NINDS anticipates the budget for these projects will normally remain under $500,000 in direct costs in any given year and fluctuate over the funding period based on the stage of the project. For example, the costs during some years may be in the $100,000- $200K in direct cost range. It is strongly recommended that all potential applicants consult NINDS staff about their anticipated project and budget very early in the planning stage a minimum of 12 weeks before submission of an application is anticipated. Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 12 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. NINDS prior approval is required for any applications proposing a budget of $500,000 in direct cost in any year of the project.
  • For the SBIR U44, only Fast-track (combined Phase I and II in one application) or Phase II U44 applications are accepted through the CREATE programs. Direct-to-Phase II is not permitted and any Phase II applications must build off of a previously funded Phase I. Phase I applications that are not part of a Fast-track application are not permitted. NIH has received a waiver from the Small Business Administration (SBA) to exceed the SBIR hard cap for specific topics such as the translational programs CREATE and BPN. Generally, NINDS will not fund SBIR Phase I applications through this program requesting more than $500,000 total funding support or project periods greater than 1 year. In addition, NINDS will not generally fund Phase II applications through this program requesting more than $2M total funding support or project periods greater than 3 years. Additional justification is needed for exceptions. Additional justification is needed for exceptions. Applicants are strongly encouraged to contact program staff before submitting an application.

 6.  How many years and how much funding can I request in my CREATE Bio Development Track (UH2/UH3 or SBIR U44) application?

  • For the UH2/UH3, the proposed project period for the UH2 phase may not exceed 2 years. The total duration of the UH2 and UH3 may not exceed 5 years.  Application budgets are not limited but must reflect the actual needs of the proposed project. Applications should rarely exceed $1M in direct costs per year during the UH2 phase and $1.5M in direct costs per year during the UH3 phase. Additional justification is needed for exceptions. It is strongly recommended that all potential applicants consult NINDS staff about their anticipated project and budget very early in the planning stage and a minimum of 12 weeks before submission of an application is anticipated.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 12 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. NINDS prior approval is required for any applications proposing a budget of $500,000 in direct cost in any year of the project.

  • For SBIR, only Fast-track (combined Phase I and II) are accepted through the CREATE programs. There is no direct to Phase II option through the CREATE program and Phase I applications that are not part of a Fast-track application are not permitted. NIH has received a waiver from the Small Business Administration (SBA) to exceed the SBIR hard cap for specific topics such as the translational programs CREATE and BPN. Generally, NINDS will not fund SBIR Phase I applications through this program requesting more than $2M total funding support, with no more than $1M total cost in any year or project periods greater than 2 years. In addition, NINDS does not generally fund Phase II applications through this program requesting more than $4.5M total funding support, with no more than $1.5M total cost in any year, or project periods greater than 3 years. Additional justification is needed for exceptions. Applicants are strongly encouraged to contact program staff before submitting an application.

 7.  If I am applying to develop a device, to which program should I apply?

Investigators who propose projects that focus on preclinical and pilot clinical studies for therapeutic devices should apply to the CREATE Devices program. There are three tracks for devices all using UH2/UH3 or SBIR U44 mechanisms:

  • Translational and Clinical Studies to Inform Final Device Design will support development of a device to test scientific hypotheses that are not feasible or practical to conduct in animal models but are critical to enable next-generation devices. Preclinical work should lead to an Investigational Device Exemption (IDE) to support a clinical study, or a Non-Significant Risk (NSR) study that does not require an IDE. It is expected that the clinical study will inform a final device design that would have to go through most, if not all, of the bench-top and preclinical animal testing on the path to clinical trials and market approval. Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and a clinical study.
  • Translational and Clinical Studies on the Path to 510(k) will support preclinical studies and the following IDE-enabled or NSR studies.  It is expected the immediate next steps upon completion of the clinical study will be a 510(k)/510(k) De Novo submission or a larger clinical trial that will lead directly to a 510(k)/510(k) De Novo submission. Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and a clinical study.
  • Translational and Early Feasibility Studies on the Path to Pre-Market Approval (PMA) or Humanitarian Device Exemption (HDE) will support applications to pursue preclinical studies for an IDE submission, with the option of also supporting the following Early Feasibility Study..   It is expected the immediate next steps upon completion of the Early Feasibility Study will be a full Feasibility Study and a Pivotal Trial in support of a PMA (Pre-Market Approval) or HDE (Humanitarian Device Exemption). Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and an Early Feasibility Study.

 8.  How many years and how much funding can I request in my device application (UH2/UH3 or SBIR U44)?

  • For the UH2/UH3, application budgets are not limited but must reflect the actual needs of the proposed project. For the pre-clinical UH2 phase an applicant should rarely exceed $1M direct cost per year for up to 3 years. For the UH3 phase an applicant should rarely exceed up to $1.5M direct cost per year for up to 4 years. The combined UH2/UH3 phase may not exceed 5 years.   Additional justification is needed for exceptions.
  • For SBIR, only Fast-track (combined Phase I and II) are accepted through the CREATE programs. There is no direct to Phase II option through the CREATE program and Phase I applications that are not part of a Fast-track application are not permitted. NIH has received a waiver from the Small Business Administration (SBA) to exceed the SBIR hard cap for specific topics such as the translational programs CREATE and BPN. Generally, NINDS will not fund SBIR Phase I applications through this program requesting more than $2M total funding support, with no more than $1M total cost in any year or project periods greater than 2 years. In addition, NINDS does not generally fund Phase II applications through this program requesting more than $4.5M total funding support, with no more than $1.5M total cost in any year, or project periods greater than 3 years. Additional justification is needed for exceptions.  Applicants are strongly encouraged to contact program staff before submitting an application.

 9.  Can past applications submitted in response to the Translational U01 program (PAR-13-022) be submitted to either the CREATE Bio Discovery or Development Track?

Yes, they can be submitted as new applications. Its encouraged that applicants address all past summary statement concerns in the application, however applicants will not be able to specifically include in the Introduction a response to the issues and criticism raised in past summary statements.

 10.  How do the previous Translational U01 Program (PAR-13-022) relate to the programs?

The previous U01 Program (PAR-13-022) program supported discovery and development of therapeutics for all therapeutic modalities. The new programs have separate announcements to support the discovery and development of small molecules, devices, and biotechnology products and biologics.  Please refer to each modality for details. The previous program went only as far as an IND while the new program supports early clinical trials.

 11.  How does the Translational R21 compare with the new programs? What types of applications should submit to the current Translational R21 program (PAR-13-023) versus the new NIH Blueprint Neurotherapeutics Network (BPN) and CREATE programs?

The current Translational R21 Program (PAR-13-023) supports discovery and development of therapeutics for all therapeutic modalities.  The new programs will have separate announcements to support the discovery and development of small molecules, devices, and biotechnology products and biologics.  Please refer to each modality for details.  In addition, the Translational R21 program supports early-stage projects with the end goals of screening for hits, development of assays and models. These early-stage end goals are not supported by the new programs.  After the expiration of the Translational R21 Program (PAR-13-023) on January 8, 2015, new programs will be targeted to cover this early stage of research.

Applicants are strongly encouraged to contact program staff and send them a draft abstract for consultation.  Program staff considers both the activities proposed, maturity of the project, and end goal intent of the project when recommending the most appropriate program. 

 12.  To what programs should small business apply?

The Small Business Innovation Research (SBIR) program is a congressionally-mandated set-aside program for small businesses. SBIR eligibility guidance can be found here  (http://www.ninds.nih.gov/funding/small-business/small_business_STTR_SBIR_eligibility_summary.htm).  SBIR-eligible small businesses should apply to the SBIR U44 version of all the CREATE Biologics and Biotechnology Products, CREATE Devices, and Blueprint Neurotherapeutics programs. All other businesses should apply through the U01 or UH2/UH3 versions of the various programs.

 13.  How can an investigator get guidance on how to write an application for these programs?

Applicants should contact NINDS program staff at least 12 weeks before a receipt date.  As a cooperative agreement, implementation will involve the participation of NINDS program staff in the planning and execution of the therapy-directed projects.  Applicants are strongly encouraged to consult with NINDS program staff when planning an application. Consultations will include conference calls with NINDS program staff. Early contact provides an opportunity for NINDS program staff to provide further guidance on program scope, goals, and developing appropriate milestones. Other aspects of an application that are unique to this program will also be discussed.

 14.  Does an applicant have to contact NINDS before they submit?

It is strongly recommended that all potential applicants consult NINDS staff very early in the planning stage and a minimum of 12 weeks before submission of an application is anticipated.

Applicants requesting $500K or more direct costs in any year (excluding consortium F&A) are required to contact NINDS program staff at least 12 weeks before submitting the application.  NINDS program staff are required to get approval to accept the application for review from senior leadership.

 15.  When were the new funding opportunity announcements (FOAs) released?

The new FOAs were released in July 2014.

 16.  When is the first receipt date for the new FOAs?

The intent is to have the first receipt date in October 2014 for all new programs discussed above.

 17.   What will be the other receipt dates?

It is expected that future receipt dates will be two receipts date a year in February and August through the end of the PARs (3 years). There will be no other receipt dates in October, other than October 2014.

 18.  When will the first set of applications be reviewed?

The first set of applications will be reviewed in early 2015.

 19.  Where will my application be reviewed?

Competing applications for all of these new programs will be reviewed within the NINDS Scientific Review Branch and not at the Center for Scientific Review (CSR).  Applications will be assigned to the appropriate review based on the FOA under which they applied.  Small business U44 applications will be reviewed in the same review meeting as U01 or UH2/UH3 applications.

 20.  When will the first set of applications be awarded?

The first set of applications will need approval from May 2015 Council and will be awarded in the summer of 2015.

 21.  May foreign work be proposed in an application?

Applications from foreign institutions or containing foreign components should apply through the U01 or UH2/UH3 mechanism and not the U44 small business mechanism. 

 22.  Should I contact NINDS program staff if I want to apply either Discovery or Development Track?  

All applicants are strongly encouraged to consult with NINDS program staff when planning an application. Applicants should contact NINDS programs staff at least 12 weeks prior to submitting an application.

 23.  When should I contact NINDS program staff if I request $500,000 or more in direct costs in any year?

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.  The Acceptance for Review of Unsolicited Applications must be approved 6 weeks prior to receipt date before an application can be submitted. To allow time for NINDS program staff and leadership to consider the request for Acceptance for Review of Unsolicited Applications, we strongly encourage applicants to contact NIH program staff at least 12 weeks before submitting the application.

 24.  How does NINDS envision encouraging the applicants to take the best therapeutics forward?

Only the most promising agents that have undergone rigorous preclinical testing and are considered state-of-the-art for the disease of interest will be considered for advancement to IND-enabling studies in the Development Track.   The Discovery Track thus affords applicants the opportunity to build collaborations, conduct comparative studies among related agents and standard of care agents, and, ultimately, advance their most promising candidate therapeutics

 25. Do I have to submit the structure/sequence for my therapeutic in my application?

Yes, disclosure of structure/sequences is required so that enough information is available to enable evaluation of the application.

 26.  Who do we contact if we have questions?

 27.  If I am interested in applying to the CREATE Bio program, what is the process?

To be able to advise you better and know who in the NINDS team will be the best to give advice, we would like to know some basic background information and what objectives you want to achieve. The information you provide is voluntary.  

Last updated August 14, 2014