Notice Number: NOT-GM-17-007
Key Dates
Release Date: May 2, 2017
PAR-17-045
Issued by
National Institute of General Medical Sciences (NIGMS)
Purpose
The purpose of this notice is to clarify the text regarding biomedical research aims in several sections of PAR-17-045 "Focused Technology Research and Development (R01)", as outlined below.
Part 2. Section I. Funding Opportunity Description
Appropriateness for this Program
Currently reads, in part:
No Biological Aims: Biomedical relevance is an essential element of NIH research. However, this stage of technology development should not include immediate short-term application of nascent technologies to challenging biomedical research questions because an insistence on explicit linkage to a specific research problem and the immediate demonstration of an immature technology’s effectiveness in that context can distort the technology development process. It can also diminish focus on development of genuinely innovative technology in favor of incremental improvements to existing technologies. In the early stages of technology development, insistence on biomedical applications is counterproductive. Therefore, in this program, application to specific biomedical questions in the timeframe of the proposed project is considered beyond the scope of the program, and should not be included. A technology R&D project in which a current biomedical problem serves as a test-bed for demonstration of the technology's impact would be too well-developed for this program, and should be the subject of a conventional R01 application under the Parent R01 FOA.
Application to well-characterized model systems to assess performance is appropriate at this stage. Applications of the technology should be limited to test systems chosen to facilitate development of the technology. The aims of the project should be focused entirely on the development of the technology.
The products of this research will be functioning prototype instruments, methods, synthetic approaches, etc., characterized adequately to be ready for first application to the type of biomedical research questions that provided the rationale for their development.
For purposes of this FOA, the following are not considered to be early stage technology development activities:
- pursuit of a biological hypothesis
- biomarker discovery or validation
- development of drugs or therapies
- new uses of existing technologies that may be ready for advanced development and validation without substantial further development efforts.
Applications proposing projects with these goals are not appropriate for this program and should be submitted elsewhere.
Modified to read:
No Biological Aims: Applications in response to this FOA must not include biological aims. Biomedical relevance is an essential element of NIH research. However, this stage of technology development should not include immediate short-term application of nascent technologies to challenging biomedical research questions because an insistence on explicit linkage to a specific research problem and the immediate demonstration of an immature technology’s effectiveness in that context can distort the technology development process. It can also diminish focus on development of genuinely innovative technology in favor of incremental improvements to existing technologies. In the early stages of technology development, insistence on biomedical applications is counterproductive. Therefore, in this program, application to specific biomedical questions in the timeframe of the proposed project is considered beyond the scope of the program. A technology R&D project in which a current biomedical problem serves as a test-bed for demonstration of the technology's impact would be too well-developed for this program, and must be the subject of a conventional R01 application under the Parent R01 FOA. Applications submitted under this FOA that include aims addressing an open biomedical question will be not be considered for funding. .
Application to well-characterized model systems to assess performance is appropriate at this stage. Applications of the technology should be limited to test systems chosen to facilitate development of the technology. The aims of the project should be focused entirely on the development of the technology.
For purposes of this FOA, the following are not considered to be early stage technology development activities:
- pursuit of a biological hypothesis
- biomarker discovery or validation
- development of drugs or therapies
- new uses of existing technologies that may be ready for advanced development and validation without substantial further development efforts.
Applications proposing projects with these goals are not early stage technology development and are not appropriate for this program.
Part 2. Section IV.2 Content and Form of Application Submission
PHS 398 Research Plan
The following text has been added.
Specific Aims:Aims in the following areas are not considered early stage technology development and should not be included: (1) pursuit of a biological hypothesis; (2) biomarker discovery or validation; (3) development of drugs or therapies; or (4) new uses of existing technologies that may be ready for advanced development and validation without substantial further development efforts. Applications submitted under this FOA that include aims addressing these topic areas will not be considered for funding.
Research Strategy
Currently reads, in part:
Applications of the technology should be limited to test systems. The research strategy should explain the rationale for the choice of test systems in terms of the desired performance of the technology and how a test system will facilitate development of the technology.
Modified to read:
The research strategy of the project should be focused entirely on the development of the technology. Applications of the technology should be limited to test systems. The research strategy must explain the rationale for the choice of test systems in terms of the desired performance of the technology and how a test system will facilitate development of the technology. Application of the technology to a current biomedical research problem is appropriate for a conventional R01 application under the Parent R01 FOA. Applications submitted under this FOA that include aims addressing an open biomedical question will not be considered for funding.
All other aspects of this FOA remain the same.
Inquiries
Please direct all inquiries to:
Douglas M. Sheeley, Sc.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: sheeleyd@mail.nih.gov
and Human Services (HHS)
