Tuesday, March 21, 2023

(NIH/NIAID) [E]" @niaid.nih.gov>, Emily Erbelding < @nih.gov>, "Poe, Kelly (NIH/NIAID) [E]" @nih.gov>, "Gilles, Sharon (NIH/NIAID) [E]" @nih.gov> Subject: Please advise by COB today 3/21: Additional questions related to SRG review of EHA grant Good morning, Background As you recall, NIH OLPA reached out recently to make us aware of congressional requests for documents related to Scientific Review Group (SRG) review of the original and renewal EHA award. NIH OLPA has indicated that HHS is likely to provide these to the congressional requestors later this week. NIH OLPA has drafted the attached “media statement” that notes a few potential vulnerabilities from comments in the summary statements. They have asked us if we have additional information on these points (bolded questions below): Vulnerabilities: 1. In the 2013 review, critique number 3 mentions that a potential overlap with PREDICT was noted. Does NIAID have additional information that we could share about how it was determined this was not double billing? 2. In the same critique, there is a note that the potential risk to human subjects is not fully addressed. Did NIAID work with the grantee to address these concerns before funding? 3. In the 2019 review, critique number 2 mentions that the letters from the two Chinese institutions were identical. Do you know if there was follow-up regarding this? Action Item By COB today, Tuesday March 21, please review the “media statement” document and provide any edits or comments. Please also provide any information responsive to the bolded questions above. If these questions are better referred to OER or other NIH components, please let us know. Thanks, Sara _____________________________________________ From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov> Sent: Wednesday, March 8, 2023 2:17 PM To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; Linde, Emily (NIH/NIAID) [E] @mail.nih.gov> Cc: NIAID OCGR Leg @mail.nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov> Subject: Please advise by 10am tomorrow: Documents for congressional requests related to EHA grant Importance: High Hello all, Background As you may be aware, the House Select Subcommittee on the Coronavirus Pandemic, as well as the House Energy and Commerce Committee, have requested documents related to EcoHealth Alliance’s NIH grants. NIH OLPA has been working with NIH OER and others to provide documents responsive to the two requests outlined below. Please note the highlighted requests from NIH OLPA outlined below regarding these document productions. Action Item Please let us know by 10am tomorrow, Thursday March 9, if you know of any additional documentation or have any concerns to flag as requested by NIH OLPA. 1. Congressional Request: All documents related to the Scientific Review Group (SRG) review of the initial R01 grant. Note from OCGR-Leg: NIH OLPA/NIH OER has identified the two attached documents below responsive to this request. Please note that we suggested that OLPA should also consult with the Center for Scientific Review. << File: December 18 2013 Summary Statement (1).pdf >> << File: February 14 2019 Type 2 Summary Statement.pdf >> NIH OLPA questions related to these documents: 1. If you know of any additional documentation from the SRG review we could share with Congress, please flag for OLPA. We have asked OER/OPERA to confirm as well. [note from OCGR-Leg: please advise if NIAID would have responsive documents. If so, we can assist with keywords and individuals for a CIT search for documents] 2. Are there any sensitivities you would like to flag? OLPA will work with OGC to redact personally identifiable information before transmission to Congress. 2. Energy & Commerce Committee Request (Follow up to prior document production consisting of Type 5 Checklists from the initial R01): Questions from the congressional staff, with proposed responses from NIH OER in red: Following up on the production of the Type 5 checklist documents, we noticed there was not an Award Worksheet Report for Year 6 of the EcoHealth award or Year 1 of the EcoHealth R02 award (depending on how you look at it). Based on this HHS OIG report (see excerpt below), the NIH may have closeout documentation for the EcoHealth R01 award. https://oig.hhs.gov/oei/reports/oei-07-11-00190.pdf. However, we would like clarification on the following: When a grant award is renewed, do NIH staff complete closeout documentation for the R01 grant in lieu of the Award Worksheet Report? NIH Response: No. If not, do NIH staff complete an Award Worksheet Report for Year 6 (the Year 1 for the R02 award)? NIH Response: Yes. If there is closeout documentation for the EcoHealth R01, please provide these materials as responsive to the request for the grant file. NIH Response: There is no closeout documentation at this time, because the award continued with the renewal (Type 2). If instead there is no closeout documentation and there is an Award Worksheet Report, please provide the Year 6 Award Worksheet Report and any other subsequent Award Worksheet Reports. NIH Response: The Year 6 Award Worksheet Reports are attached. << File: AWS4298904 9.28.22.pdf >> << File: AWS3993758 9.15.21.pdf >> << File: AWS3672471 7.15.20.pdf >> << File: AWS3602757 4.27.20.pdf >> << File: AWS3438397 8.5.19.pdf >> << File: AWS3424934 7.24.19.pdf >> For background - OER/OPERA Response: Thanks to our OPERA colleagues, we can offer the following explanation. There are actually 6 award worksheets for the Type 2 due to the actions outlined below: · 7-24-19: initial award · 8-5-19: budget adjustment · 4-27-20: termination—award zero’d out · 7-15-20: award reinstated · 9-15-21: award extended (mid-budget period) · 9-28-22: WIV termination; budget renegotiated to remove aims involving WIV NIH OLPA questions related to these responses/documents: Please let us know if you have any concerns or flags Sara Selgrade, Ph.D. Section Chief for Legislative Activities Legislative Affairs and Correspondence Management Branch Office of Communications and Government Relations NIAID/NIH/DHHS Bldg. 31, Room 7A17, MSC 2520 Bethesda, MD 20892-2520 Phone: @mail.nih.gov Disclaimer: The information in this e mail and any of its attachments is confidential and may contain sensitive information. It should not be used by anyone who is not the original intended recipient. If you have received this e-mail in error please inform the sender and delete it from your mailbox or any other storage devices. National Institute of Allergy and Infectious Diseases shall not accept liability for any statements made that are sender's own and not expressly made on behalf of the NIAID by one of its representatives.