Notice Number: NOT-OD-17-045
Key Dates
Release Date: March 14, 2017
PAR-17-144
Issued by
National Institutes of Health (NIH)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
Purpose
The purpose of the Notice is to correct the instructions under Section IV.2 Content and Form of Application Submission, Research & Related Other Project Information (Pilot Research) section. Inclusion of previously funded projects will be placed under Other Attachments rather than within the Research Strategy.
Current Instructions:
Research & Related Other Project Information (Pilot Research)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Revised Instructions:
Research & Related Other Project Information (Pilot Research)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Other Attachments: The following attachment should be included in order to aid in the review of the application. The file name provided for each attachment will be the name used for the bookmark in the application image. All attachments should be in .pdf format.
Previously Funded Pilot Projects: Please title this attachment "Previously Funded Pilot Projects." For the previous funding period, provide, for each funded pilot project, a narrative not more than one page in length that includes the following: Project title; Name, title, and institutional affiliation of the principal investigator; Year(s) funded; Abstract, including Specific Aims; Full bibliographic material on each paper published, in press or submitted, resulting from the pilot project, note do not include abstracts; and Grant applications and funded grants resulting from the pilot project.
Current Instructions:
PHS 398 Research Plan (Pilot Research)
Research Strategy:
The Pilot Research Program is required and described in Section I. Provide the following information on the Pilot Research Program:
- Overall description of the Pilot Research Program, including governance, organizational chart, proposal format, and review procedures including a scoring system for evaluation and means for obtaining written critiques. Describe the composition of the review committee, which must consist of at least 4 members and at least 2 of the members must be external to the NPRC and grantee institution.
- Describe any plans to encourage participation by early-state investigators and/or investigators who have not previously performed research with NHPs.
- If proposed, outline the expedited review process to be used under ORIP-approved exceptional circumstances.
- Documentation of the mechanisms used to publicize the Pilot Research Program.
- For each year of the previous funding period, a list of the reviewers of the pilot project proposals, including titles and institutional affiliations.
- A table that lists, for each year of the previous funding period:
- The number of applications received.
- The number of applications funded.
- The number of funded projects that involved researchers inside and outside of the NPRC, respectively.
- The total amount of pilot funding.
- Plans for the Pilot Research Program for the next funding period, including any changes from the previous funding period, anticipated funding levels, and plans to publicize the program. If a specific subject area has been the subject of pilot program solicitations, briefly justify the importance of that subject area for research using NHPs.
- For the previous funding period, provide, for each funded pilot project, a narrative not more than one page in length that includes the following:
- Project title.
- Name, title, and institutional affiliation of the principal investigator.
- Year(s) funded.
- Abstract, including Specific Aims.
- Full bibliographic material on each paper published, in press or submitted, resulting from the pilot project. Do not include abstracts.
- Grant applications and funded grants resulting from the pilot project.
- A table showing the sources and amounts of funding for the unit for the last funded year of the existing P51 base grant and the first proposed year of the P51 base grant renewal. The table should provide detailed information, which is used to calculate the information in the Overall Section. Sources of funding should be broken down as follows, and as applicable to the unit:
- Support from the P51 base grant.
- Program income derived from the P51 base grant.
- Support from other sources (not including the P51 base grant or program income derived from the P51 base grant).
- Total support for the unit.
Vertebrate Animals: If answered affirmative for Vertebrate Animals, refer to the overall VAS for general procedures and interventions to minimize pain and distress. For the specific unit, include any research-specific procedures, such as imaging or surgical procedures, as well as interventions to minimize pain and distress. Address species justifications related to the specific field of research.
Letters of Support: The applicant may include letters of support related to the specific unit.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Revised Instructions:
PHS 398 Research Plan (Pilot Research)
Research Strategy:
The Pilot Research Program is required and described in Section I. Provide the following information on the Pilot Research Program:
- Overall description of the Pilot Research Program, including governance, organizational chart, proposal format, and review procedures including a scoring system for evaluation and means for obtaining written critiques. Describe the composition of the review committee, which must consist of at least 4 members and at least 2 of the members must be external to the NPRC and grantee institution.
- Describe any plans to encourage participation by early-state investigators and/or investigators who have not previously performed research with NHPs.
- If proposed, outline the expedited review process to be used under ORIP-approved exceptional circumstances.
- Documentation of the mechanisms used to publicize the Pilot Research Program.
- For each year of the previous funding period, a list of the reviewers of the pilot project proposals, including titles and institutional affiliations.
- A table that lists, for each year of the previous funding period:
- The number of applications received.
- The number of applications funded.
- The number of funded projects that involved researchers inside and outside of the NPRC, respectively.
- The total amount of pilot funding.
- Plans for the Pilot Research Program for the next funding period, including any changes from the previous funding period, anticipated funding levels, and plans to publicize the program. If a specific subject area has been the subject of pilot program solicitations, briefly justify the importance of that subject area for research using NHPs.
- A table showing the sources and amounts of funding for the unit for the last funded year of the existing P51 base grant and the first proposed year of the P51 base grant renewal. The table should provide detailed information, which is used to calculate the information in the Overall Section. Sources of funding should be broken down as follows, and as applicable to the unit:
- Support from the P51 base grant.
- Program income derived from the P51 base grant.
- Support from other sources (not including the P51 base grant or program income derived from the P51 base grant).
- Total support for the unit.
Vertebrate Animals: If answered affirmative for Vertebrate Animals, refer to the overall VAS for general procedures and interventions to minimize pain and distress. For the specific unit, include any research-specific procedures, such as imaging or surgical procedures, as well as interventions to minimize pain and distress. Address species justifications related to the specific field of research.
Letters of Support: The applicant may include letters of support related to the specific unit.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Inquiries
Please direct all inquiries to:
Sheri Hild
Office of Research Infrastructure Programs
Telephone: 301-594-8937
Email: [email protected]
and Human Services (HHS)
