PROCESS FOR E-MAIL SUBMISSIONS OF PRIOR APPROVALS FOR NIH GRANTS AND COOPERATIVE AGREEMENTS Release Date: January 6, 2000 NOTICE: OD-00-009 National Institutes of Health Introduction This Notice implements the process by which grantees may submit prior approval requests for NIH grants and cooperative agreements via e-mail. It is intended that, whenever practical and efficient, all steps in the submission of prior approval requests from grantee institutions and the replies from NIH to such requests be done electronically. This Notice does not represent a change in policy with regard to prior approval requirements discussed in the NIH Grants Policy Statement (NIHGPS), "ADMINISTRATIVE REQUIREMENTS, Changes in Project and Budget" (page II-52, located at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#adminreq). Rather, it is a change in formal procedure to allow these requests to be submitted and replied to via e-mail. The procedures for submitting such requests are detailed below. All requests for NIH awarding office prior approval must be made, in writing, to the to the awarding office Grants Management Officer listed on the Notice of Grant Award no later than 30 days before the proposed change. Failure to obtain prior approval, when required, from the appropriate NIH awarding office may result in the disallowance of costs, termination of an award, or other enforcement action within NIH"s authority. Grantee Procedures: o The Principal Investigator (PI) initiates the request, and includes his/her title, institution, telephone number, fax number and e-mail address. Internal institutional guidelines for the evaluation and approval of the request are the responsibility of the grantee institution. The request, when submitted to NIH, must be transmitted by the authorized institutional official. o When transmitting the request, the authorized institutional official"s name, title and institution, telephone number, fax number and e-mail address must be included. It is understood that the transmission of electronic prior approval requests is a clear expression of institutional approval and that all internal procedures have been properly completed. Additionally, the grantee will be responsible for any internal distribution of the request. o The request should include the complete grant number in the subject line of the e-mail. o All information and justification must be included in plain text in the body of the e-mail request. If unable to transmit the entire request in the body of the e-mail message then the request in its entirety must be submitted via "hard-copy." o The requests should be sent to the Grants Management Officer who signs the Notice of Grant Award. E-mail addresses for NIH staff can be obtained from the National Institutes of Health Directory and E-mail Forwarding Service, located at http://directory.nih.gov/ NIH Procedures: o When the Grants Management Officer receives an e-mail prior approval request, it will be routed or distributed in accordance with internal Institute/Center procedures. A determination will be made to approve, disapprove or seek additional information, as required. o If for any reason NIH staff has a concern about the authenticity of an e- mail prior approval request they will contact the authorized institutional official to confirm that the e-mail message in question is genuine. An example of a reason that may prompt such a call would be if the e-mail address of the sender does not clearly indicate the domain of the grantee institution. o Once a decision has been reached, the Grants Management Officer or his/her designee will reply directly to the authorized institutional official, with a copy to the PI and the NIH scientific program official. If necessary, NIH will revise the appropriate Notice of Grant Award. The grantee institution will be responsible for any internal distribution of the NIH response. o The normal NIH response time should be within 30 days of the receipt of the e-mail request, and NIH"s acceptance of the request. o All replies from NIH grants management staff will include the Grants Management official"s name, title, NIH Institute or Center, telephone number, fax number and e-mail address. o All e-mail requests for prior approval and subsequent replies will be filed in the NIH official grant file, and will be available for future reference. Content of Prior Approval Requests The following outline is intended to be helpful to grantees in presenting the content necessary for NIH staff to properly evaluate requests that require prior approval. This is a reiteration of current practice and does not represent a change in prior approval policy requirements stated in the NIHGPS. If all required information, outlined below, is not provided in the initial request, it may be necessary for NIH staff to request additional information from the grantee. This could result in a substantial delay of any decision being rendered on the original request. This is not an all-inclusive list of actions requiring prior approval. The ability to submit a prior approval request to NIH via e-mail, whenever practical and efficient, applies to all prior approval actions, which are discussed in the NIHGPS, "ADMINISTRATIVE REQUIREMENTS, Changes in Project and Budget." If you have a question about the content of a prior approval request please discuss the nature of your request with the Grants Management Specialist listed on your Notice of Grant Award. Change in PI or other key personnel named in the NGA o Scientific justification o If applicable, describe the change in effort level o Updated other support, submitted in the format described in the PHS 398 application, Format Page 7. o Biographical sketch information for proposed PI or key personnel, if not previously available from the grant application. o o Biographical sketch information is as follows: 1. Name, position, title 2. Education/training: begin with baccalaureate or other initial or other professional education (such as nursing) and include postdoctoral training. List as follows: institution and location, degree (if applicable), year(s), field of study 3. Research and professional experience: concluding with present position, list, in chronological order, previous employment, experience, and honors. Include present membership on any Federal Government public advisory committee. List, in chronological order, the titles, all authors, and complete references to all publications during the past three years and to representative earlier publications pertinent to this application. If the list of publications in the last three years exceeds two pages, select the most pertinent publications. Significant reduction in effort Grantees are required to notify NIH if the PI or other key personnel named in the Notice of Grant Award (NGA) will reduce his or her time devoted to the project by 25 or more percent from the level that was approved at the time of award o Scientific justification o Role of personnel involved o Describe the change in effort level o Describe the duration of change o Indicate what rebudgeting may occur as a result of the significant reduction in effort (not applicable to modular awards) Establish a consortium or transfer of substantive programmatic work to a third party Please note that for awards under expanded authorities or the FDP, prior approval to establish a consortium is only required when the consortium represents a change in scope. o Scientific justification o Statement of intent to establish the necessary inter-institutional agreement consistent with NIHGPS policy. o Indicate the status of the appropriate assurances for the consortium entity o Indicate the effect on the budget as a result of establishing a consortium o Indicate whether or not the establishment of a consortium will result in a change in scope. o Assure that request will not change the existing total cost commitment for current and future budget periods No-cost extension requests This is not applicable for the first no-cost extension for awards under expanded authorities or the FDP. Extensions beyond the first no-cost extension of a competitive segment are highly unusual and only approved with strong justification. o Scientific justification, including progress to date o Length of extension requested o Amount of and reason for the unobligated balance o Plan for use of funds during extension period. Include categorical budget detail, in text format, of requested direct and F&A costs. Carryover requests Please note that this action is generally allowable without prior approval under expanded authorities or the Federal Demonstration Partnership (FDP) unless restricted on the terms of award. Contact the Grants Management Specialist identified on the Notice of Grant Award to discuss issues related to individual requests for carryover. o Scientific justification for carryover o Amount of funds requested for carryover. o If balance is significant (25% of the current budget period"s total costs), provide explanation of why funds available for the requested carryover were not used o Plan for use of carryover funds. Include categorical budget detail, in text format, of requested direct and F&A costs Significant rebudgeting requests For awards under expanded authorities or the FDP, prior approval for significant rebudgeting is only required when the rebudgeting represents a change in scope. Awards issued under SNAP are required to notify NIH of significant rebudgeting as a part of the noncompeting award process. Please note that prior approval of significant rebudgeting no longer applies to awards issued from modular grant applications. o Scientific justification o Amount of funds to be rebudgeted o Indicate which budget categories funds will be moved from and to o Indicate the implications on F&A costs o Indicate whether there will there be a change in scope o Assure that request will not change the existing total cost commitment for current and future budget periods Questions regarding this Guide Notice may be directed to the Grants Management Specialist identified on the Notice of Grant Award.
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