ORA Closeout Process for NIH Awards

Office of Research Administration ORA Closeout Process for NIH Awards ORA CLOSEOUT GUIDELINES ORA is responsible for making sure that necessary closeout documents are submitted to NIH within 90 days of the project end date. Although there are 3 closeout documents that are required by NIH, the Office of Research Administration is responsible for overseeing that the FIS (Final Invention Statement) and FPR (Final Progress Report) are submitted for closeout. The Office of Sponsored Program is responsible for submitting the FFR (Federal Financial Report). NIH will show a project as closed out once all 3 of these documents have been received. The pre-award and post-award offices (ORA and OSP) work together to ensure that this happens. ORA currently maintains a tracking database showing when a project is ending to ensure that we comply with the sponsor s closeout requirements and deadlines based on the Notice of Award. ORA is also responsible to educate the departments on the closeout process by providing resourceful tools that show the PI and Grant Administrators in the departments how to process the FIS and FPR by using the electronic closeout feature on era Commons. We strongly encourage the departments to use the electronic closeout feature on Commons since it is a more efficient and faster way for closeout documents to be processed and received by NIH. CLOSEOUT PROCESS FOR DEPARTMENTS Below are the steps for departments to follow when closing out a project with NIH. Please note that the PI will need to use their Commons login information in order for the electronic submission feature for closeout to be available on the site: 1) Upon the project start date, the department/pi should review all of the terms and conditions for Closeout Requirements in the Notice of Award that is sent from NIH. The closeout expectations are stated in this Notice so that the PI is aware of any future reporting requirements for when the project ends. 2) When the project ends, NIH will automatically send out a closeout notification to the PI reminding them of their reporting requirements and that the necessary documents are due to NIH within 90 days after the project end date. 3) Within 90 days of the project end date, the PI is responsible for completing and submitting the Final Invention Statement and Final Progress Report to NIH. The submission of these documents can be done by logging on to era Commons and searching for the grant that requires closeout. Once the PI locates the grant on the website, then the electronic closeout process can begin by clicking on the Requires Closeout function in the Actions column. FINAL INVENTION STATEMENT The Final Invention Statement requires 2 signatures in order for the document to be valid and accepted by NIH: One signature must be from the PI and the other signature from an Institutional Signing Official. 1) To initiate the Final Invention Statement, the PI will first need to indicate if there were any inventions listed during the project period (see Attachment 1 for Commons screen shots). A hard copy of the Final Invention Statement no longer needs to be completed since the closeout feature now offers this process electronically. 2) Once the PI initiates and submits the electronic Final Invention Statement, NIH will automatically send a notification to ORA stating that a Signing Official is now required to verify the invention statement that the PI has submitted. ORA Closeout Process for NIH Awards 1

FINAL INVENTION STATEMENT: (continued) 3) Before ORA can verify the Final Invention Statement via Commons, we are obligated to confirm with the Office of Licensing and Ventures if any inventions have been reported for that particular grant. Even if the PI has indicated none for inventions, to ensure compliance, ORA would still need to confirm this with the Licensing office. 4) Upon confirmation with the Licensing office, an ORA Signing Official will verify the invention statement electronically on Commons. Once this occurs, the statement is automatically submitted to era Commons showing both electronic signatures. NIH will now consider this document as received for closeout. Please note that the completed Final Invention Statement can be accessed and viewed at any time once it has successfully been submitted electronically through era Commons. FINAL PROGRESS REPORT The Final Progress Report does not require a signature; however, in order for the document to be valid and accepted by NIH, it can only be uploaded to era Commons by either the PI or Signing Official. 1) To upload the Final Progress Report, the PI will be prompted to attach the PDF file from their computer and submit the report by following the prompts on the screen (see Attachment 1 for Commons screen shots). 2) Once the PI has uploaded the Final Progress Report file, NIH will automatically send a notification to ORA for their records. Please note that the Final Progress Report can be accessed and viewed at any time once it has been successfully uploaded electronically through era Commons. FEDERAL FINANCIAL REPORT The PI does not need to take any action with initiating the Federal Financial Report since this document is handled by the Office of Sponsored Programs (OSP). There are specific officials in OSP who have been designated with the Financial Status Reporter (FSR) role to create and submit this report through the closeout feature on era Commons. If the department or PI has any questions or concerns with the completion of the FFR, please email OSP at: sponsoredprograms@duke.edu FINALIZING THE CLOSEOUT PROCESS Once all of the required closeout documentation has been submitted through era Commons, the PI will no longer receive reminder notifications from NIH. The project will be noted as closed out. TECHNICAL TROUBLESHOOTING WITH COMMONS SYSTEM If the PI is having technical difficulties with era Commons and is unable to access the Closeout feature electronically on the website, please contact the Commons Help Desk at (866) 504-9552. In the event that these technical difficulties are not resolved within a timely manner, the PI can email copies of the Final Invention Statement and Final Progress Report to their appropriate / assigned ORA Grants Specialist. ORA will assist the PI by uploading or emailing hard copies of these documents to NIH. (see Attachment 2 for hard copy template of Final Invention Statement). ORA Closeout Process for NIH Awards 2

Electronic Research Administration Sponsored by: The National Institutes of Health, Office of Extramural Research Closeout Closeout The Closeout process includes: Final Financial Status Report (FSR) Final Progress Report Final Inventions Statement 666 33

Closeout - FSR Final Financial Status Report (FSR) Must have an account with the FSR role to create/submit the FSR FSRs due on/after October 1, 2007, must be submitted electronically using era Commons NIH Guide Notice: NOT-OD-07-078 http://grants.nih.gov/grants/guide/notice-files/not-od- 07-078.html 6767 Closeout Progress Report Either the PI or the SO can create/upload the final Progress Report. Select Submit. Browse to select file for upload. Select OK. 6868 34

Closeout Invention Statement If Inventions are to be reported, the specific inventions must be listed. Either the PI or the SO can start the process, but both must verify the report before submitting to Agency. 6969 Closeout Invention Statement 7070 35

Closeout Invention Statement Select Verify. Verify saved inventions. Remove any that do not apply. Add any that are missing. Select OK. 7171 Closeout Status changed to Awaiting SO Verification. SO can now verify and submit. Hands-on Closeout Create and upload Final Progress Report. Initiate and Verify Final Invention Statement. 7272 36

Form Approved Through 06/30/2012 OMB No. 0925-0001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Procedure for Submission of Final Invention Statement and Certification (For Grant or Award) Form HHS 568 A Final Invention Statement and Certification (Form HHS 568) shall be executed and submitted within 90 days following the expiration or termination of a grant or award. The Statement shall include all inventions which were conceived or first actually reduced to practice during the course of work under the grant or award, from the original effective date of support through the date of completion or termination. The Statement shall include any inventions reported previously for the grant or award as part of a non-competing application. This reporting requirement is applicable to grants and awards by Department of Health and Human Services in support of research. The Final Invention Statement and Certification does not in any way relieve the person responsible for the grant or award, or the institution, of the obligation to assure that all inventions are promptly and fully reported directly to the National Institutes of Health, as required by terms of the grant or award. Information regarding the reporting of inventions, including the reporting form to be followed, may be obtained from the Office of Policy for Extramural Research Administration, Division of Extramural Inventions and Technology Resources, 6705 Rockledge Drive MSC 7980, Bethesda, Maryland 20892-7980, Telephone: (301) 435-1986. The original of the completed Final Invention Statement and Certification is to be returned to the awarding component that funded the grant or award. The entire grant or award number must appear in the designated box on the form. The period covered by the Final Invention Statement is the project period of the grant or award at a particular grantee institution. If no inventions were involved, insert the word None in the first block under item Title of Invention. Each Statement requires the signature of an institution official authorized to sign on behalf of the institution. The PHS estimates that it will take from 5 to 10 minutes to complete this form. This includes time for reviewing the instructions, gathering needed information, and completing and reviewing the form. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. If you have comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing this burden, send comments to: NIH, Project Clearance Office, 6701 Rockledge Drive MSC 7730, Bethesda, MD 20892-7730, ATTN: PRA (0925-0001). Do not send this form to these addresses; they are for comments only. HHS 568 (Rev. 06/09) Instructions

Department of Health and Human Services Final Invention Statement and Certification (For Grant or Award) Form Approved Through 06/30/2012 OMB No. 0925-0001 DHHS Grant or Award No. A. We hereby certify that, to the best of our knowledge and belief, all inventions are listed below which were conceived and/or first actually reduced to practice during the course of work under the above-referenced DHHS grant or award for the period through. original effective date date of termination B. Inventions (Note: If no inventions have been made under the grant or award, insert the word NONE under Title below.) NAME OF INVENTOR TITLE OF INVENTION DATE REPORTED TO DHHS (Use continuation sheet if necessary) C. Signature This block must be signed by an official authorized to sign on behalf of the institution. Title Name and Mailing Address of Institution Typed Name Signature Date HHS 568 (Rev. 06/09)

Privacy Act Statement The PHS maintains application and grant records as part of a system of records as defined by the Privacy Act: 09-25-0112, Grants and Cooperative Agreements: Research, Research Training, Fellowship, and Construction Applications and Related Awards. The Privacy Act of 1974 (5 USC 522a) allows disclosures for routine uses and permissible disclosures. Some routine uses may be: 1. To the cognizant audit agency for auditing. 2. To a Congressional office from a record of an individual in response to an inquiry from the Congressional office made at the request of that individual. 3. To qualified experts, not within the definition of DHHS employees as prescribed in DHHS regulations (45 CFR 5b.2) for opinions as part of the application review process. 4. To a Federal agency, in response to its request, in connection with the letting of a contract or the issuance of a license, grant, or other benefit by the requesting agency, to the extent that the record is relevant and necessary to the requesting agency s decision on the matter; 5. To organizations in the private sector with whom PHS has contracted for the purpose of collating, analyzing, aggregating, or otherwise refining records in a system. Relevant records will be disclosed to such a contractor, who will be required to maintain Privacy Act safeguards with respect to such records. 6. To the sponsoring organization in connection with the review of an application or performance or administration under the terms and conditions of the award, or in connection with problems that might arise in performance or administration if an award is made. 7. To the Department of Justice, to a court or other tribunal, or to another party before such tribunal, when one of the following is a party to litigation or has any interest in such litigation, and the DHHS determines that the use of such records by the Department of Justice, the tribunal, or the other party is relevant and necessary to the litigation and would help in the effective representation of the governmental party. a. the DHHS, or any component thereof; b. any DHHS employee in his or her official capacity; c. any DHHS employee in his or her individual capacity where the Department of Justice (or the DHHS, where it is authorized to do so) has agreed to represent the employee; or d. the United States or any agency thereof; where the DHHS determines that the litigation is likely to affect the DHHS or any of its components. 8. A record may also be disclosed for a research purpose, when the DHHS: a. has determined that the use or disclosure does not violate legal or policy limitations under which the record was provided, collected, or obtained; b. has determined that the research purpose (1) cannot be reasonably accomplished unless the record is provided in individually identifiable form, and (2) warrants the risk to the privacy of the individual that additional exposure of the record might bring; c. has secured a written statement attesting to the recipient s understanding of; and willingness to abide by, these provisions; and d. has required the recipient to: (1) establish reasonable administrative, technical, and physical safeguards to prevent unauthorized use or disclosure of the record; (2) destroy the information that identifies the individual at the earliest time at which removal or destruction can be accomplished consistent with the purpose of the research project, unless the recipient has presented adequate justification of a research or health nature for retaining such information; and (3) make no further use or disclosure of the record, except (a) in emergency circumstances affecting the health or safety of any individual, (b) for use in another research project, under these same conditions, and with written authorization of the DHHS, (c) for disclosure to a properly identified person for the purpose of an audit related to the research project, if information that would enable research subjects to be identified is removed or destroyed at the earliest opportunity consistent with the purpose of the audit, or (d) when required by law. The Privacy Act also authorizes discretionary disclosures where determined appropriate by the PHS, including to law enforcement agencies, to the Congress acting within its legislative authority, to the Bureau of the Census, to the National Archives, to the General Accounting Office, pursuant to a court order, or as required to be disclosed by the Freedom of Information Act of 1974(5 USC 552) and the associated DHHS regulations (45 CFR Part 5). HHS 568 (Rev. 06/09) Privacy Act

FINAL PROGRESS REPORT NIH Grant Number: Principal Investigator: Project Title: Project Start Date: Project End Date: Insert Full Grant ID Insert Name Insert Title Insert Date Insert Date Final Progress Report (FPR) There is no standard form for this report; however, this template may be useful in completing the progress report. The final progress report should include a summary of progress toward the achievements of the originally stated aims, a list of significant results, a list of publications, and whether or not human subjects were included in the research. For more detailed information regarding the completion of Final Progress Reports, please visit: o http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch8.htm#_final_progress_report 1