Reading Room Production — page 131

board should or <ing provisions that mandate the provision of ncerns. Those ot support this legislation, we remain 5 PM [AID DEA DART J ID DIR-OCGR < ID DCR-OCGR ay NIAID) (NIH/NIAID) [E] [E] J 4/NIAID) [E] I I VIH/NIAID) [I] iy >; PF (NIH/NIAID) [E] IIH/NIAID) [--] NIAID) [E] 'nate Committee on S is now requesting any Review criteria: The bill does not articulate a principle or threshold that guides whether the board should or should not approve a study for funding - for example, should the Board approve research where it determines that the potential public health benefits of the research outweigh the potential risks to U.S. national security? Or should some other standard govern the Board's review? Any statute mandating this style of review should clarify the applicable standard. Classified review and intelligence concerns: We recommend striking provisions that mandate the provision of security clearances to Board members, Board staff, and members of Congress, or that require these individuals to access and review all classified research funded by any agency. Those provisions extend beyond the scope of oversight that is reasonable for this board to take on and they may impinge on the constitutional authority of the Executive to control classified national security information. We also recommend that clauses be included to enable the intelligence community to respond to requests from the Board in a manner consistent with the protection of intelligence sources and methods. Enforcement: The enforcement provisions are extreme and may raise significant legal and privacy concerns. Those provisions mandate a suite of harsh penalties for any violations of certain provisions of the statute, including technical or unintentional violations; they allow for no flexibility in determining the severity of punishment; they provide the aggrieved party with no process; and they mandate public identification of aggrieved individuals. These provisions could broadly disincentivize individuals from working in life sciences research and funding agencies, which could send research outside of this country and compromise progress on public health, safety, and national security. We recommend that enforcement provisions be focused on willful violations and significantly reduced or adjusted. Given the above concerns, as drafted, this legislation has the potential to negatively impact innovation and delay the development of lifesaving technologies. While the Administration does not support this legislation, we remain committed to working with the Committee on biosafety and biosecurity. From: Crawford, Chase (NIH/NIAID) [E] Sent: Wednesday, September 25, 2024 1:45 PM To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR- @mail.nih.gov>; NIAID DCR-OCGR @mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @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: ACTION by COB Friday (9/27): Review revised bill text for Risky Research Review Act Good Afternoon, NIAID has been asked to review the revised bill text for the Risky Research Review Act (PDF of bill text and Word doc of the redline are attached). This morning, the attached version of the bill was reported out of the Senate Committee on Homeland Security & Governmental Affairs (HSGAC) and now awaits further Senate consideration. As you may recall, NIH and other OPDIVs provided comments on a previous version of the bill (previous NIAID comments attached for reference). HHS is now requesting any new comments that OPDIVS may have.