REVISED OCTOBER 2018. This document applies to all NIH grants and cooperative agreements for budget periods beginning on or after October 1, 2018
Reporting, financial reports, progress reports, non-competing continuation progress reports, requirements for commons ID, expectation for institutions to develop individual development plans for graduate students and postdoctoral researchers, streamlined non-competing award process, modified annual progress reports, modified NoAs, modified financial reporting requirements, submitting SNAP progress reports, progress reports for multiyear funded awards, final research performance progress report (F-RPPR), financial reports, cash transaction requests, financial expenditure reports, revised financial reports and expenditures, unobligated balances and actual expenditures, recipient reporting of subrecipient data and executive compensation information for federal funding accountability and transparency act (FFATA), invention reporting, and financial conflict of interest reporting
NIH requires that recipients periodically submit financial and progress reports. Other required reports may include annual invention utilization reports, lobbying disclosures, conflict of interest reports, audit reports, reports to the appropriate payment points (in accordance with instructions received from the payment office), and specialized programmatic reports. Recipients also are expected to publish the results of research in peer-reviewed journals and to provide information to the public on the objectives, methodology, and findings of their NIH-supported research activities, as specified in Administrative Requirements-Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resources.
The GMO is the official receipt point for most required reports. However, NIH has centralized the submission of annual progress reports; details are provided below. In addition, electronic submission through the eRA Commons is required for some annual progress reports and available for all closeout documents (final grant progress reports, final invention statements and certifications, and final financial status reports). When a paper non-competing continuation progress report is submitted, only a signed original is required; no copies are required. Submission of these reports to an address other than the centralized one may result in delays in processing of the non-competing continuation award or the submission being considered delinquent. FFRs must be electronically submitted to OFM (see Financial Reports below) through the eRA Commons eFFR feature unless otherwise indicated in the award's terms and conditions.
Recipients are allowed a specified period of time to submit required financial and final progress reports (see 45 CFR Parts 75.341 and 75.342, and the discussion in this subsection). Failure to submit complete, accurate, and timely reports may indicate the need for closer monitoring by NIH or may result in possible award delays or enforcement actions, including withholding, removal of certain NIH Standard Terms of Award, or conversion to a reimbursement payment method (also see Administrative Requirements-Enforcement Actions). The schedule for submission of the non-competing continuation progress report is discussed in the next subsection.
Progress reports usually are required annually as part of the non-competing continuation award process. NIH may require these reports more frequently. The "Non-Competing Continuation Progress Report" (PHS 2590) or equivalent documentation (e.g., Research Performance Progress Report [RPPR]) must be submitted to, and approved by, NIH to non-competitively fund each additional budget period within a previously approved project period (competitive segment). Except for awards subject to SNAP, the progress report includes an updated budget in addition to other required information.
NIH requires the use of the RPPR for all Type 5 progress reports, including accessing the Human Subjects System link in the RPPR, if applicable, that will allow reporting of inclusion enrollment data.
Recipients should routinely query and review the list of pending grant progress reports and due dates available at the NIH Web site (https://public.era.nih.gov/chl/public/search/progressReportByIpf.era). Late submission of a grant progress report will result in delaying the issuance and funding of the non-competing continuation award and may result in a reduced award amount.
Recipients also have an obligation to submit a complete and accurate progress report. NIH program or grants management staff may require additional information to evaluate the project for continued funding. Failure to provide this information will result in a delayed award. Incomplete or inadequate progress reports may result in a delay of continued support.
The progress report for the final budget period of a competitive segment for which a competing continuation application is submitted will be part of that application; however, if an award is not made or the recipient does not submit an application for continued support, a final RPPR is required (see Final Research Performance Progress Report).
The NIH awarding ICThe NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. will specify the requirements for progress reporting under construction grants or grants supporting both construction activities, including acquisition or modernization, major alteration and renovation, and non-construction activities.
The paper non-competing Progress Report includes an All Personnel Report on which the recipient must report the PD/PI(s) and all individuals who devoted one person monthThe metric for expressing the effort (amount of time) PD/PI(s), faculty and other senior/key personnel devote to a specific project. The effort is based on the type of appointment of the individual with the organization; e.g., calendar year, academic year, and/or summer term; and the organization's definition of such. For instance, some institutions define the academic year as a 9-month appointment while others define it as a 10-month appointment. or more effort to the project. The eRA Commons ID must be provided on this report for the PD/PI(s) and those who worked on the project in a postdoctoral role.
For progress reports using the RPPR, the Commons ID requirement is part of the Participants Section and is required for the PD/PI(s) and those who worked on the project in a postdoctoral role. This could include project roles such as Postdoctoral Associate and other similar Postdoctoral positions.
For undergraduate and graduate students supported on a particular research grant, a Commons ID will be required effective with RPPRs submitted October 17, 2014 and beyond. Undergraduate and Graduate Student Roles have been added to the Commons to accommodate this requirement; recipients are encouraged to begin registering these individuals now. For graduate students, this could include project roles of graduate research assistant or graduate student.
When an individual is assigned the Undergraduate, Graduate Student, and/or Postdoctoral Role in the Commons, responses to certain data items in the Personal Profile tab will be required to meet NIH reporting requirements to Congress included in the NIH Reform Act, P.L. 109-482.
Note, the Graduate Student and Postdoctoral eRA Commons Roles should NOT be used for individuals submitting Individual Fellowships; the PD/PI role is used for those submissions. Nor should they be used for individuals supported on institutional training grants and reported using xTrain; the Trainee Role must continue to be used for those individuals.
A Commons ID is strongly encouraged, but currently optional, for all other project personnel. A general Commons Role of Project Personnel is available for those not assigned other Commons Roles.
220.127.116.11.2 Expectation for Institutions to Develop Individual Development Plans for Graduate Students and Postdoctoral Researchers
In an effort to assist graduate students and post-doctoral researchers in achieving their career goals and become contributing members of the biomedical workforce, NIH encourages recipients to develop an institutional policy requiring that an Individual Development Plan (IDP) be implemented for every graduate student and postdoctoral researcher supported by any NIH grant and reportable on the progress report, regardless of the type of NIH grant that is used for support. This is an expectation that should be broadly implemented by institutions for all graduate students and postdoctoral researchers supported by NIH. The actual reporting of the implementation of this expectation is in the RPPR; recipients must report in RPPR Section B. Accomplishments, Question B.4 the use of the IDP for graduate students and/or postdoctoral researchers included in RPPR Section D. Participants or on a Statement of Appointment Form (PHS 2271). Do not include the actual IDP; instead include information to describe how IDPs are used, if they are used, to help manage the training for those individuals.
SNAP includes a number of provisions that modify annual progress reports, NoAs, and financial reports.
The NoANotice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. will specify whether an award is subject to SNAP. Awards routinely included in SNAP are "K" awards and "R" awards, except R35. Awards excluded from SNAP are those that generally do not have the authority to automatically carry over unobligated balances (centers; cooperative agreements, Kirschstein-NRSA institutional research training grants, non-Fast Track Phase I SBIR and STTR awards), clinical trials (regardless of activity code), P01, R35, and awards to individuals. However, these grants can be included in SNAP on a grant-specific basis. In addition, specific awards may be excluded from SNAP if:
- they require close project monitoring or technical assistance, e.g., high-risk recipients, certain large individual or multi-project grants, or grants with significant unobligated balances, or
- the recipient has a consistent pattern of failure to adhere to appropriate reporting or notification deadlines.
While a modified, streamlined, progress report is still a feature of grants awarded under the SNAP authorities, a streamlined version of the RPPR has replaced the eSNAP module in the eRA Commons. For all SNAP awards, the progress report is submitted using this streamlined version of the RPPR that does not include detailed budget information.
Under SNAP, the GMO negotiates the direct costsCosts that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. for the entire competitive segment at the time of the competing award or, in the case of modular awards, determines the applicable number of modules for each budget period within the competitive segment. This eliminates the need for annual budget submissions and any negotiations, and reduces the information NIH requires to review, approve, and monitor non-competing continuation awards. SNAP NoAs are issued with only total direct and F&A costsNecessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived. awarded for the budget period. While direct costsCosts that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. categorical breakdowns are not awarded, recipients are required to allocate and account for costs by category in accordance with applicable cost principlesThe government-wide principles, issued by OMB (or, in the case of commercial organizations, the Federal Acquisition Regulation [48 CFR 21], or, in the case of hospitals, 45 CFR 75, Appendix IX, "Principles For Determining Costs Applicable to Research and Development Under Grants and Contracts with Hospitals"), on allowability and unallowability of costs under federally sponsored agreements. See Cost Considerations-The Cost Principles for additional details.. Future year commitments on SNAP awards reflect total cost commitments (direct plus F&A costsNecessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived.).
For awards under SNAP (other than awards to foreign organizations issued prior to October 1, 2012 or Federal institutions), an FFR is required only at the end of a competitive segment rather than annually. The FFR must be submitted within 120 days after the end of the competitive segment and must report on the cumulative support awarded for the entire segment. An FFR must be submitted at this time whether or not a competing continuation award is made. If no further award is made, this report will serve as the final FFR (see Administrative Requirements-Closeout).
For awards under SNAP (other than awards to foreign organizations and Federal institutions), recipients also are required to submit a quarterly FFR cash transaction data to PMS.
Annual FFRs are required for awards issued to foreign organizations prior to October 1, 2012 and all awards issued to Federal institutions, even if an award is under SNAP. (Also see Administrative Requirements-Monitoring-Reporting-Financial Reports.)
SNAP awards issued to foreign and international organizations after October 1, 2012, will be required to submit FFR expenditure data within 120 days of the end of the competitive segment instead of annually. These awards are not required to submit a quarterly FFR cash transaction data to PMS.
All SNAP progress reports are due the 15th of the month preceding the month in which the budget period ends (e.g., if the budget period ends 11/30, the due date is 10/15). If the 15th falls on a weekend or Federal holiday, the due date is automatically extended to the next business day. Paper submissions are not acceptable, will not be used for consideration for funding, and will not become part of the official file. If a paper SNAP progress report is submitted, recipients will be required to resubmit the information electronically.
The RPPR module in the eRA Commons allows recipients to electronically prepare and submit progress reports and supporting documentation. The RPPR module provides the user with dedicated screens to collect the required progress report information, including appropriate uploads for text documents. Data submitted through RPPR for Performance Sites and Participants is retained in the system to assist the recipient in completion of future progress reports.
The RPPR may be routed to authorizing officials at the applicant institution for review and approval prior to submission to NIH. For SNAP awards, the RPPR module provides recipients with the option to delegate to the PD/PI the authority to submit the progress report directly to NIH. This optional authority is managed on a PD/PI basis in the eRA Commons; such authority can be rescinded at any time.
Guidance on RPPR submission is documented in the RPPR Instruction Guide found at: http://grants.nih.gov/grants/RPPR/.
A limited number of NIH grant awards are multi-year funded, i.e., not funded in budget years but funded in full at the start of the project period from a single fiscal year appropriation. The project period and the budget period are the same in a multi-year funded (MYF) award, and are longer than one year. Progress reports for MYF awards are due annually on or before the anniversary of the budget/project period start date of the award. A progress report is not required if the award is in a no-cost extension period unless specifically required by the ICThe NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.. The reporting period for a MYF progress report is the calendar year preceding the anniversary date of the award. For example, if an award is made on 04/01/2014, the MYF progress report is due on or before 04/01/2015, and should report on the activities performed under the award between 04/01/2014 and 03/31/2015. For the subsequent year the MYF progress report will be due 04/01/2016, and should report on the activities performed under the award between 04/01/2015 and 03/31/2016. Information on the content of a MYF progress report and instructions on how to submit the report through the eRA Commons are posted at http://grants.nih.gov/grants/policy/myf.htm and http://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf. The multi-year research performance progress report (MYRPPR) link to upload the report will be available two months before the anniversary date of the award, on the eRA Commons Status search page in the folder "List of Applications/Grants" in the "Action" column. Progress reports for MYF awards must be completed by the PD/PI, and then submitted by a Signing Official (SO) or a PD/PI with delegated authority from the SO to submit a progress report. Information about SO delegation of authority to a PD/PI to submit a progress report appears in the eSNAP User Guide under Section 2. Delegating Authority.
The F-RPPR has replaced the Final Progress Report for closeout. NIH is no longer accepting Final Progress Reports. Generally, the F-RPPR format is the same as the current annual RPPR. As part of the F-RPPR recipients will be required to report on Project Outcomes. This section will be made publicly available, allowing recipients the opportunity to provide the general public with a concise summary of the cumulative outcome or findings of the project (analogous to the Project Summary/Abstract section of the competing application).
NIH will not maintain its previous Type 2 policy which stated that "whether funded or not" the progress report contained in the Type 2 application may serve in lieu of a separate final progress report. NIH now requires that organizations submit an Interim-RPPR while their Type 2 is under consideration. In the event that the Type 2 is funded, NIH will treat the Interim-RPPR as the annual performance report for the final year of the previous competitive segment. If the Type 2 is not funded, the Interim-RPPR will be treated by NIH staff as the institution's F-RPPR.
Two types of financial reports are typically used. Cash transaction data is submitted on a quarterly basis directly to PMS. Expenditure data is submitted directly to the NIH. Historically this data was submitted using 2 separate forms, the SF272 and the SF269. Now the SF425, called the Federal Financial Report (FFR), is used for collecting both types of financial data. For NIH recipients, it is important to note that while the data is now submitted using the same form, there is no change in the actual receipt and processing of data. Cash transaction data continues to be submitted directly to and processed by PMS. Expenditure data continues to be submitted directly to and processed by NIH.
The FFR has a dedicated section to report Federal cash receipts and disbursements. For domestic recipients this information is submitted quarterly directly to the PMS using the web-based tool. Quarterly reports are due 30 days following the end of each calendar quarter. The reporting period for this report continues to be based on the calendar quarter. Questions concerning the requirements for this quarterly financial report should be directed to the PMS.
For awards issued to foreign organizations after October 1, 2012, even though payment is now through PMS, the requirement for quarterly cash reporting does not apply. These awards are now administered in PMS using subaccounts and payments will be specific to each grant at the time the recipient draws funds. (See also Grants to Foreign Organizations â€“ Administrative Requirements â€“ Reporting and Record Retention.)
Reports of expenditures are required as documentation of the financial status of grants according to the official accounting records of the recipient organization. NIH requires all financial expenditure reports to be submitted using the Federal Financial Report (FFR) system located in the eRA Commons. This includes all initial FFRs being prepared for submission and any revised FSR/FFRs being submitted or re-submitted to NIH. The eRA Commons Federal Financial Report (FFR) system allows participants to view information on currently due and late expenditure reports and to submit these reports electronically to NIH. Paper expenditure reports are not accepted. Expenditure data submitted to NIH is initially reviewed and accepted by OFM. NIH ICThe NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. grants management staff also review these expenditure reports.
Except for awards under SNAP and awards that require more frequent reporting, the FFR is required on an annual basis. An annual FFR is required for awards to foreign organizations made prior to October 1, 2012 and Federal institutions made prior to October 1, 2013, whether or not they are under SNAP. When required on an annual basis, the report must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter. Failure to submit timely reports may affect future funding. The report also must cover any authorized extension in time of the budget period. If more frequent reporting is required, the NoANotice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. will specify both the frequency and due date.
In lieu of the annual FFR expenditure data, NIH will monitor the financial aspects of grants under SNAP by using the information submitted directly to PMS. The GMO may review the report for patterns of cash expenditures, including accelerated or delayed drawdowns, and to assess whether performance or financial management problems exist. For these SNAP awards, FFR expenditure data is required only at the end of a competitive segment. It must be submitted within 120 days after the end of the competitive segment and must report on the cumulative support awarded for the entire segment. An FFR must be submitted at this time whether or not a competing continuation award is made. If no further award is made, this report will serve as the final FFR (see Administrative Requirements-Closeout).
Before submitting FFRs to NIH, recipients must ensure that the information submitted is accurate, complete, and consistent with the recipient's accounting system. When submitting the FFR through the eRA Commons, the AOR or the individual designated to submit this report on behalf of their institution, certifies that the information in the FFR is correct and complete and that all outlays and obligations are for the purposes set forth in grant documents, and represents a claim to the Federal government. Filing a false claim may result in the imposition of civil or criminal penalties.
Revisions for F&A Changes. Each Financial Report and Cash Expenditure Report submitted by the recipient shall reflect the proper amount of F&A costsNecessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived. applicable to the grant period. If a provisional or an earlier period's permanent rate is used in the report, a subsequent adjustment to the FSR is necessary if a lower permanent rate(s) applicable to the grant is established, except for Institutions of Higher Education (IHEs) subject to 45 CFR 75.
Revised Expenditure Reports. NIH requires all financial expenditure reports (domestic and foreign) to be submitted using the electronic FFR system located in eRA Commons. This includes the initial FFR and any FSR/FFR revisions being submitted or re-submitted to NIH. In some cases the recipient may have to revise or amend a previously submitted FSR/FFR. The revised report should be submitted in the same format as the original; e.g., if the original was an FSR, the revision will also be submitted using the FSR format. When the revision results in a balance due to NIH, the recipient must submit a revised report whenever the overcharge is discovered, no matter how long the lapse of time since the original due date of the report. Revised expenditure reports representing additional expenditures by the recipient that were not reported to NIH within the 90-day time frame may be submitted electronically through the eFSR/FFR system to OFM with an explanation for the revision. The explanation also should indicate why the revision is necessary and describe what action is being taken by the recipient to preclude similar situations in the future. This should be done as promptly as possible, but no later than 1 year from the due date of the original report for annual FFRs and no later than 60 calendar days from the due date of the original report for final FFRs (i.e., 180 days from the project end date). If an adjustment is to be made, the NIH awarding ICThe NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. will advise the recipient of actions it will take to reflect the adjustment.
Disposition of unobligated balances is determined in accordance with the terms and conditions of the award. (See Administrative Requirements-Changes in Project and Budget for NIH approval authorities for unobligated balances.) Using the principle of "first in-first out," unobligated funds carried over are expected to be used before newly awarded funds.
Upon receipt of the annual FSR/FFR for awards other than those with authority for the automatic carryover of unobligated balances, the GMO will compare the total of any unobligated balance shown and the funds awarded for the current budget period with the NIH share of the approved budget for the current budget period. If the funds available exceed the NIH share of the approved budget for the current budget period, the GMO may select one of the following options:
- In response to a written request from the recipient, revise the current NoANotice of Award: The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. to authorize the recipient to spend the excess funds for additional approved purposes.
- Offset the current award or a subsequent award by an amount representing some or all of the excess.
18.104.22.168.5 Recipient Reporting of Subrecipient Data and Executive Compensation Information for Federal Funding Accountability and Transparency Act (FFATA)
A component of Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires most recipients of new Federal funds awarded on or after October 1, 2010 to report on subawards/subcontracts/consortiums equal to or greater than $25,000. This includes awards that are initially below $25,000 but subsequent grant modifications result in an award equal to or greater than $25,000.
The FFATA Subaward Reporting System (FSRS) tool can be accessed directly at www.fsrs.gov, and will serve as the collection tool for subaward data which will ultimately be distributed for publication and display on www.USASpending.gov. Recipients are required to register with FSRS, collect the necessary data from subawardees, and file subaward reports by the end of the month following the month in which the prime recipient awards any subaward greater than $25,000.
FFATA specifies the data that should be captured for each prime recipient and first-tier subrecipient of Federal awards, regardless of award type. To promote data consistency and reduce reporting burdens, existing agency data sources will be leveraged to pre-populate reports for prime awardees as well as for subawardees when available. Recipients are responsible for confirming the pre-populated data and providing any additional required information.
Included in these requirements is the need to report the names and total compensation of the five most highly compensated officers of the entity if the entity as part of their registration profile in SAM in the preceding fiscal year: 1) received 80 percent or more of its annual gross revenues in Federal grants, subawards, contracts, and subcontracts; and 2) received $25,000,000 or more in annual gross revenues from Federal grants, subawards, contracts, and subcontracts; and 3) had gross income, from all sources, of $300,000 or more; and 4) the public does not have access to this information about the compensation of the senior executives of the entity through periodic reports filed under section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. Â§Â§ 78m(a), 78o(d)) or section 6104 of the Internal Revenue Code of 1986. See FFATA Â§ 2(b)(1). Additionally, recipient organizations may be required to verify the following information in FSRS:
- Organization DUNS number
- Name and Address of organization
- Parent DUNS number
- CFDA number
- Federal Awarding Agency of the grant
A complete list of the reporting requirements under the Bayh-Dole Act can be found at 37 CFR 401.14. The requirements also are specified in Administrative Requirements-Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resources.
In addition to complying with Bayh-Dole-related regulations, each NIH competing grant application and non-competing continuation progress report must indicate whether or not any subject inventions were made during the preceding budget period. If inventions were made, the recipient must also indicate whether they were reported.
The recipient also must submit an annual invention utilization report for all subject inventions to which title has been elected and inventions that have been licensed but not patented (research tools). The utilization report provides a way to evaluate the extent of commercialization of subject inventions, consistent with the objectives of the Bayh-Dole Act.
A recipient's failure to comply with invention reporting requirements and/or associated NIH policies on intellectual property and resource sharing may result in the loss of patent rights or a withholding of grant funds or other enforcement actions, including the imposition of special terms and conditions.
Bayh-Dole regulations allow recipients to report inventions electronically (37 CFR 401.16). NIH requires electronic reporting through an Internet-based system, Interagency Edison (http://iEdison.gov). To meet the objectives of the Federal Financial Assistance Management Improvement Act of 1999 (P.L. 106-107), recipients should make all reasonable efforts to submit invention reports using iEdison. The system supports confidential transmission of required information and provides a utility for generating reports and reminders of pending reporting deadlines. Further information about the system, including instructions for creating an account needed to submit reports electronically, are on the iEdison site. Recipients also may contact the Division of Extramural Inventions and Technology Resources Branch, OPERA, OER. See Part III for contact information.
Information related to FCOI reporting requirements can be found within Public Policy Requirements -- Financial Conflict of Interest.