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edon -"oncerns lidated 's, Chase @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov> Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>; Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov> Subject: FYI - Update on TA for revised bill text for Risky Research Review Act FYI - Bldg. 1 has asked NIAID to provide a few top line bullets outlining the types of comments that were submitted on the redline version of the bill. NIAID plans to share the below bullets and indicate that NIAID shares many of the concerns raised by OER, ORS, and OSP (their top line bullets are copied further below). We will request a copy of the consolidated NIH TA and share it with you if/when we receive. Please let us know if you have any questions at this time. Thanks, Chase NIAID NIAID notes that, to avoid confusion, the definitions in the bill pertaining to scientific and/or current policies should be consistent with definitions in science and those policies, including the USG Policy for Oversight of DURC and PEPP (https://www.whitehouse.gov/wp-content/uploads/2024/05/USG-Policy-for-Oversight-of-DURC-andPEPP.pdf). Further, as written, some definitions are overly broad and could slow research in critical areas, including research on antimicrobial resistance and the H5 influenza outbreak in dairy cattle. NIAID also notes that, as written, the proposed Board may lack essential expertise in infectious diseases and biosecurity. NIAID notes that it is unclear if it is the drafters' intent to prohibit funding for an entire award prior to Board approval or only work related to potential "high-risk" research. Similarly, there is a later provision that would require a pause in research due to a change in circumstance, but it is unclear if such a pause would apply to an entire award or only work related to potential "high-risk research. OER It is unclear what added value the Board may have over current processes. The Board seems redundant with existing/current efforts and/or those being implemented following OSTP's mandate on DURC/PEPP. The Board's scope is very broad and may apply to a variety of research areas. We defer to OSP on the included research definitions. The Board will have significant control over funding decisions, which may interfere with existing statute on NIH funding activities. We have concerns about the Board reaching out directly to applicants/recipients, which is outside traditional NIH reporting procedures. The required timeline of some Board activities is unclear. Flagged in previous TA, we have concerns about the confidentiality of application information and recommend more details be provided on how such information will be used or protected. Flagged in previous TA, some terms such as "proposal" and "entity" should be updated to better agree with NIH terminology. Flagged in previous TA, requirements for the validation of all applicant attestations related to research risk would be extremely challenging to implement. ORS Concern over the confusion and differences between agent listing, some definition and intent of this as compared to the new DURC PEPP policy and also the current/ transparent process by which select agents are added or removed. We would recommend alignment 100% in line with the current SA policies and DURC PEPP policies. Curious if this Board would be subject to posting in the Federal Register with public comment, or would function in a more draconian approach. Acknowledging that risk assessment is best when diverse voices are heard, the lack and actually clear refusal to ensure persons with experience in high and maximum containment principles are included would not provide a comprehensive and scientifically robust review of this work.