Nih R01/r21 Prepare/review/submission Checklist Page 4

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computational, human, invertebrate, in vitro).
3. Minimization of Pain and Distress: Describe the interventions including analgesia, anesthesia,
sedation, palliative care and humane endpoints to minimize discomfort, distress, pain, and injury.
4. Euthanasia: State whether the method of euthanasia is consistent with the recommendations of the
American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not,
describe the method and
provide a scientific justification.
.
o
Failure to address the four points above will result in the application being designated as
incomplete and it will not be
considered.
More information can be found at:
Select Agents - See SF424 for instructions; should be completed if project uses hazardous
o
biological agents or toxins.
Multiple PI Plan - A rationale for choosing a multiple PD/PI approach should be described. The
o
governance and organizational structure of the leadership team and the research project
should be described, including communication plans, process for making decisions on
scientific direction, and procedures for resolving conflicts.
Consortium/Contractual Arrangements :
For MBL internal procedures; for Contractors - a letter of intent is required; for Subcontracts – a
o
completed Subrecipient Commitment Form is required. For the NIH proposal, this section
should describe arrangement with the subawardees .
Letters of Support - Except for MBL persons being charged to the budget include one for
o
each person named in Senior/Key Persons to affirm their participation. If a consultant
letter is included, ensure it states the rate and hours expected to dedicate to project.
Resource Sharing Plan - Data Sharing required for proposals greater than $500,000 TDC per
o
year and some PA/RFAs . Model Organisms Plan required wherever they might be
developed
Appendix – note NIH limits in SF424 on numbers and types of publications that can be included.
4.6 Selecting Budget: (Two options exist)
Applicants should refer to the instructions in their specific Funding Opportunity Announcement
FOA and should carefully read the application guide for detailed instructions. As a general rule, if
an application meets the modular limit of $250K in direct costs for all budget periods, the applicant
must submit a modular budget. Similarly, if an application exceeds $250K in direct cost for any
budget period, the detailed R&R Budget form must be used. Foreign applicants must use the R&R
Budget form. The applicant should complete the budget component appropriate to their situation.
1.
PHS 398 Modular Budget – when requesting $250,000 Direct Cost or less /year
2.
R&R Categorical Budget – when requesting $250,001 or more Direct Cost/year
Notes:
If personnel have effort without salary, that is cost sharing and not allowed.
o
Be aware of the NIH salary cap in effect. For a categorical budget, can request salary in excess of
o
the cap and NIH will reduce at time of award.
https://grants.nih.gov/grants/policy/salcap_summary.htm
Salary limitations for Undergraduates and Postdocs can be found at:
o
In general modular budgets are used only for RO1, RO3, R15, R21 and R34 applications.
o
All budget categories should be justified in R & R Budget; Personnel in Modular Budget.
o
Unless the PA/RFA requests-do NOT use Budget Section E-Participant/Trainee Support Costs
o
Foreign institutions and international organizations may request funds for limited F&A costs
o

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