COVID-19 NIH Updates

The Health Sciences Sponsored Project Pre-Award Office will remain open and operational and will continue to provide service to our department partners, faculty, academics, physicians, and scholars. Because of the evolving situation with COVID-19 and because the health and welfare of our staff and their families is of highest priority, we are providing our teams with the flexibility they need in terms of telecommuting while maintaining our commitment to our clients and the organization. We expect some adjustments as we adapt to operating in these uncertain and rapidly changing times, and we appreciate and thank you for your understanding and patience. Please note, these workplace adjustments will not impact your ability to reach out to your current HS SPPO contacts who will continue to be available to help.

If you have any questions, please e-mail eswilson@health.ucsd.edu

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UC & UC San Diego Updates Related to COVID-19

UC Office of the President: How UC is Responding to the Coronavirus (COVID-19)

Memo: Charging grants and contracts costs to Federal sponsored awards during COVID-19 (3/24/2020)

UC San Diego: COVID-19 Information
UC San Diego - IACUC: Current Operational Status in Response to Coronavirus Pandemic
UC San Diego - Health: Novel Coronavirus (COVID-19) Information
UC San Diego - HRPP: UCSD IRB Updates Regarding COVID-19
UC San Diego - OCGA: Guidance from Sponsors and Research Partners Regarding the Impact of COVID-19 on Research
UC San Diego - Office of Research Affairs (ORA): COVID-19: Continuity of Research

At-a-Glace summary of Federal sponsor guidance regarding COVID-19 flexibilities affecting contracts and grants: At a glance summary
Links to detailed sponsor guidance regarding impacts of COVID-19 on contract and grant administration: Guidance from Sponsors and Research Partners
FAQ’s related to COVID-19 impact on contracts and grants: FAQ’s
COVID-19 Funding Opportunities and Resources: Funding Opps and Multi-campus Research Programs and Initiatives RFP

NIH Updates Related to COVID-19

COVID-19 Information for NIH Applicants and Recipients
COVID-19 FAQs for COVID-19 Flexibilities for Applicants and Recipients
Update on COVID-19 Flexibilities for the Research Community on YouTube (posted 3/26/2020)

Dr. Mike Lauer, NIH Deputy Director for Extramural Research, provides updates for the research community on flexibilities NIH is providing the community due to the COVID-19 public health emergency.

NIH Message to Applicants and Recipients of NIH Funds on Flexibilities Needed for COVID-19 on YouTube (posted 3/17/2020)

Dr. Mike Lauer, NIH Deputy Director for Extramural Research, provides an update for applicants and recipients of federal funding on flexibilities NIH has put in place to support them and their research through the disruptions caused by COVID-19.

Notices

NOT-OD-20-091	UPDATE: NIH Late Application Policy Due to Public Health Emergency for United States for 2019 Novel Coronavirus (COVID-19)
NOT-HS-20-007	Notice of Intent: Revision Supplements to Existing AHRQ Grants and Cooperative Agreements to Address Health System Responsiveness to COVID-19
NOT-HS-20-008	Notice of Intent: New Funding Opportunity Announcement to Support Novel, High-Impact Studies Evaluating Health System and Healthcare Professional Responsiveness to COVID-19
NOT-OD-20-087	Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19
NOT-OD-20-086	Flexibilities Available to Applicants & Recipients of Federal Financial Assistance Affected by COVID-19
NOT-OD-20-083	General FAQs - Proposal Submission and Award Management Related to COVID-19
NOT-OD-20-082	NIH LATE APPLICATION POLICY Due to Public Health Emergency for US for COVID-19

FOAs

PA-20-163	Competing Revisions to Existing NIH Grants and Cooperative Agreements (Clinical Trial Optional)	This needs to be used in conjunction with COVID-19 specific NOSIs.
PA-20-135	Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional)	This needs to be used in conjunction with COVID-19 specific NOSIs.
PA-18-935	Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)	This needs to be used in conjunction with COVID-19 specific NOSIs.
PA-18-591	Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)	This needs to be used in conjunction with COVID-19 specific NOSIs.
RFA-AI-20-028	Partnerships for Countermeasures against Select Pathogens (R01 Clinical Trials Not Allowed)	NIAID IC specific FOA. This FOA will support development of a candidate therapeutic against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19 as well as this FOA will support development of a candidate vaccine against SARS-CoV-2, the virus that causes COVID-19.

NOSIs

NOT-AD-20-030	Notice of Special Interest (NOSI) regarding the Availability of Urgent Competitive Revisions for Research on the 2019 Novel Coronavirus (2019-nCoV)	NIGMS NIAID	*This notice will be rescinded as of 4/9/2020 and replaced by NOT-AI-20-034 for NIAID competitive revisions and NOT-GM-20-025 for NIGMS competitive revisions.
NOT-HL-757	Notice of Special Interest (NOSI): Availability of Administrative Supplements and Revision Supplements on Coronavirus Disease 2019 (COVID-19)	NHLBI
NOT-DA-20-047	Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements and Urgent Competitive Revisions for Research on the 2019 Novel Coronavirus	NIDA
NOT-EB-20-003	Notice of NIBIB's Participation in PA-20-135 "Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional)"	NIBIB
NOT-TR-20-011	Notice of Special Interest (NOSI): Clinical and Translational Science Award (CTSA) Program Applications to Address 2019 Novel Coronavirus (COVID-19) Public Heath Need		CTSA (CTRI) award specific
NOT-AI-20-040	Notice of Early Expiration of "Notice of Special Interest (NOSI) regarding the Availability of Urgent Competitive Revisions for Research on the 2019 Novel Coronavirus (2019-nCoV)"	NIGMS NIAID	NOT-AI-20-030 expires 4/9/2020 and will be replaced by NOT-AI-20-034 for NIAID competitive revisions and NOT-GM-20-025 for NIGMS competitive revisions.
NOT-GM-20-025	Notice of Special Interest (NOSI) regarding the Availability of Urgent Competitive Revisions for Research on Coronavirus Disease 2019 (COVID-19) and the Causative Virus SARS-CoV-2	NIGMS	NIGM issued this NOSI to highlight the urgent need for research on SARS-CoV-2 and Coronavirus Disease 2019 (COVID-19). Applications in response to this NOSI must be submitted to PA-18-935 "Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)", which is intended to provide funds for NIH grantees applying to expand the scope of their active grant.
NOT-AI-20-034	Notice of Special Interest (NOSI) regarding the Availability of Emergency Competitive Revisions for Research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19)	NIAID	NIAID issuied this NOSI to highlight the need for research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). Applications in response to this NOSI must be submitted using the following targeted funding opportunity: PA-20-135; Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional), which is intended to provide funds for NIH grantees applying to expand the scope of their active grant. The funding instrument, or activity code, will be the same as the parent award. All activity codes of currently funded NIAID grants are eligible. Please note: NOT-AI-20-034 is specific for PA-20-135. NIH grantees seeking additional funds for research responsive to the SARS-CoV-2/COVID-19 outbreak that falls within the scope of an ongoing grant should instead apply for an administrative supplement under NIH PA-18-591.
NOT-ES-20-014	Notice of Special Interest: NIEHS Worker Training Program Coronavirus and Infectious Disease Response Training (Admin Supp Clinical Trial Not Allowed)	NIEHS	The purpose of this NOSI is to provide support for the conduct of worker-based training to prevent and reduce exposure of hospital employees, emergency first responders, and other workers who are at risk of exposure to Coronavirus through their work duties. Applicants must be an active grantee of RFA-ES-19-003, "Hazardous Materials Worker Health and Safety Training (U45 Clinical Trials Not Allowed)", RFA-ES-19-004, "HAZMAT Training at DOE Nuclear Weapons Complex (UH4 Clinical Trial Not Allowed)" , RFA-ES-15-018, "Worker Training Program (WTP) Ebola Biosafety and Infectious Disease Response Training (UH4)", or RFA-ES-19-009 - SBIR E-Learning for HAZMAT and Emergency Response (R43/R44 Clinical Trial Not Allowed). Applications in response to this NOSI must be submitted using the following targeted funding opportunity: PA-20-135
NOT-AI-20-031	Notice of Special Interest (NOSI): Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19)	NIAID	Submit applications for this initiative using one of the following FOAs or any reissues of these announcement through the expiration date of this notice: PA-19-052: NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed) PA-19-053: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed) PA-18-591: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp - Clinical Trial Optional) PA-19-056: NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) PA-19-272: PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) PA-19-270: PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
NOT-TR-20-012	Notice of Special Interest (NOSI): Repurposing Existing Therapeutics to Address the 2019 Novel Coronavirus Disease (COVID-19)	NCATS	Urgent need for research on the 2019 novel coronavirus (SARS-CoV-2) and the disease it causes. NCATS is soliciting applications to PAR-17-465, PAR-18-462, and PAR-18-332.
NOT-AG-20-022	Notice of Special Interest (NOSI): NIA Availability of Administrative Supplements and Revision Supplements on Coronavirus Disease 2019 (COVID-19)	NIA	Administrative supplement work that is proposed through PA-18-591 must be within the general scope of the research or training that is already supported. Applications that involve a change in scope (e.g., the addition of human subjects to a grant that has not been previously so coded and approved, the addition of vertebrate animals to a grant that has not been previously so coded and approved) must apply through PA-18-935.

Other Relevant Resources Related to COVID-19

Council on Governmental Relations (COGR):

CDC: Coronavirus (COVID-19)
Office of Management and Budget (OMB)

OMB M-20-17 Administrative Relief for Recipients and Applicants of Federal Financial

“This memorandum provides similar administrative relief listed in M-20-11 to an expanded scope of recipients affected by the loss of operational capacity and increased costs due to the COVID-19 crisis. Many of the operational impacts and costs are unknowable at this point, as they will depend on the spread of the coronavirus and response dictated by public health needs. This memorandum provides short term relief for administrative, financial management, and audit requirements under 2 CFR Part 200, Uniform Administrative Requirements, Cost principles and Audit Requirements for Federal Awards, without compromising Federal financial assistance accountability requirements. As program managers are considering administrative relief, they should be prudent in their stewardship of Federal resources which includes giving consideration to potential offsets-e.g. reduction in training and travel. In addition, the flexibilities provided within this memorandum, agencies are reminded of their existing flexibility to issue exceptions on a case-by-case basis in accordance with 2 CFR § 200.102, Exceptions. M20-11 shall continue to apply, and Appendix A describes the exceptions granted under this memorandum to recipients affected by the loss of operational capacity. These exceptions are time limited and will be reassessed by 0MB within 90 days of this Memo.”

OMB M-20-11 Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19)

"The Office of Management and Budget (0MB) has identified the following agency actions to relieve short term administrative, financial management and audit requirements under 2 CFR 200, Uniform Administrative Requirements, Cost principles and Audit Requirements for Federal Awards, without compromising Federal financial assistance accountability requirements. In accordance with 2 CFR § 200.102, Exceptions, 0MB is allowing Federal agencies to grant class exceptions in instances where the agency has determined that the purpose of the Federal awards is to support the continued research and services necessary to carry out the emergency response related to COVID-19. Further, agencies are reminded of their existing flexibility to issue exceptions on a case-by-case basis in accordance with 2 CFR § 200.102, Exceptions. The Administration will evaluate if these flexibilities should be extended to recipients whose operations have been adversely impacted in the emergency response related to COVID-19 at a later date."