G2G Bio Bulletin – September 14, 2026
Upcoming Public Comment Deadlines
- 2027 Physician Fee Schedule: Comments are due this coming Monday, September 14 at 11:59 pm ET. If you need a comment letter template, please respond to this email!
- Proposed Reorganization at NIAID: NIH will be be accepting comments until September 18 on a proposal that would disestablish the Division of Clinical Research (DCR) and realign its projects and functions across the NIAID Office of the Director (OD), Division of Intramural Research (DIR), and Division of Microbiology and Infectious Diseases (DMID).
- Small Business Size Standards: SBA will be accepting comments until September 21 on proposed changes that among other provisions, would expand the definition of a ‘small business’ to encompass firms with revenue of up to $1 B and 3000 employees. A summary of the proposal can be found here, and you can access a comment letter template here.
Updates from Washington
Congress: The House conducted very limited legislative business. The chamber will reconvene next week but has cancelled votes for the final two weeks of the month. The Senate will return on Monday and be in session for three weeks.
- The Chairman of the House Science, Space and Technology Committee, Rep. Brian Babin (R-TX) and its Investigations and Oversight Subcommittee Chair Rep. Rich McCormick (R-GA) have written to the leadership of the NIH, NSF and Department of Energy requesting information on how their agencies are advancing U.S. leadership in biotechnology research while protecting against biosecurity and research security risks, including whether they have implemented recommendations from the National Security Commission on Emerging Biotechnology (NSCEB).
Administration & Agencies:
- FDA:
- Three acting heads of agency divisions have been re-appointed in a permanent capacity. They are: Dr. Michael Davis to lead CDER, Karim Mikhail to lead CBER and Dr. Bret Koplow to lead the Center for Tobacco Products. Additionally, Jared Seehafer has been appointed as the inaugural Deputy Commissioner for Technology and Artificial Intelligence.
- Dr. Davis and other FDA affiliates published a piece in the New England Journal of Medicine, on a new framework for evaluating psychedelics for treatment of mental illness. The framework notably includes acceptance of clinical trials of candidate psychedelic therapies that compare their efficacy against that of established therapies (or the candidate psychedelic at a lower dose) instead of placebos.
- CDC:
- A federal judge has ruled against a coalition of states challenging the validity of HHS Secretary Kennedy’s appointments to the Advisory Committee on Immunization Practices (ACIP), while leaving open their ability to challenge the Administration's changes to the childhood immunization schedule.
- The agency has formally declared the end of the cyclosporiasis outbreak.
- CMS
- OBBA: The agency has released guidance on a ‘tiered’ framework that states can use to better determine how Medicaid recipients can be evaluated for the 'medical frailty’ exemption from work requirements outlined in the OBBA.
- White House, Other HHS Agencies & Departments:
- The White House has announced that it will send refunds of $500 to almost a million people who purchased ACA plans without subsidies.
- The Army has released its 2026 Biodefense Strategy with the aim of ensuring a service-wide effort to mitigate and neutralize threats to readiness from biological hazards.
Reminders
- Request for Information on Changes to Reporting Outcomes from NIH Peer Review due October 13
- Don’t miss the monthly GBG Report call every third Thursday of the month at 12 pm ET where the team discusses the latest federal life sciences funding opportunities. G2G has raised $624M and is eager to share our expertise to help companies grow and accelerate bringing innovations to patients.
- G2G's 2026 MHSRS Report is now live!