| Dear FASEB Board Members, Member Society Volunteer Leaders, and Staff, Staff and volunteer leaders at FASEB are aware of a notice issued by the Department of Health and Human Services (HHS) in the Federal Register on March 3 announcing the Department is rescinding long-standing policy on the use of the "notice and comment" procedures for rulemaking associated with "public property, loans, grants, benefits, or contracts." Since 1971, HHS has utilized a policy known as the "Richardson Waiver," which required the Department to use "Notice and Comment" procedures as defined by the Administrative Procedure Act for the development and finalization of rules and regulations pertaining to public property, loans, grants, benefits, or contracts. For the FASEB community, this waiver meant organizations and individuals had the opportunity to provide feedback on actions being considered by HHS leadership related to public property, loans, grants, benefits or contracts. The Administrative Procedure Act is part of the federal regulatory or rulemaking process, and thus HHS agencies like the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the Centers for Medicare and Medicaid Services (CMS) are most directly affected by this change. National Institutes of Health (NIH) rarely utilizes the rulemaking process; however, FASEB staff continue to monitor this update to determine changes in NIH's strategy in collecting stakeholder feedback on the development of new or revision of existing funding mechanisms through Requests for Information (RFIs). As many of you are aware, FASEB frequently submits feedback to NIH through RFIs, including those seeking input on agency-wide or individual Institute/Center strategic plans, agency-wide policies, and potential new funding mechanisms. FASEB does not plan to issue a public statement at this time since we are still trying to understand how the HHS notice will affect NIH (as you are aware, we do not advocate for FDA, CDC, or CMS). On a more positive note, we are seeing an increasing number of signs that the restrictions placed on HHS agency communications are slowly being lifted. "News from NIH" mailings resumed approximately two weeks ago, and a Federal Register notice announcing upcoming convenings of four study sections – the first such notice since January 22 – is set to publish on March 4. Although not "business as usual," these are promising signs of a return to somewhat normal processes at NIH. FASEB plans to connect with Jay Bhattacharya, MD, the administration's nominee to serve as NIH Director, once he is confirmed and sworn in to learn more about his priorities for the agency and highlight the importance of engaging the research community on agency policy and funding strategies. I encourage you to share this update with members of your society to ensure they are aware of the most current information and FASEB's efforts to support transparent policy making. Please do not hesitate to reach out directly to me, your designated FASEB Board representative, or Frank Krause (fkrause@faseb.org) to share your thoughts and concerns. Sincerely, Beth A. Garvy, PhD
FASEB President |