A Funding Reprieve Via CR, but Challenges Ahead;Next Steps in the Executive Branch’s Shaping of Possible ARPA-H
Top-Line:
Alliance Webinar At 3 P.M. today with Dr. William Slikker, Director of the FDA’s National Center for Toxicological Research - Still Time to Sign Up.
A Funding Reprieve Via CR, but Challenges Ahead.
Next Steps in the Executive Branch’s Shaping of Possible ARPA-H.
Additional upcoming Alliance webinars: Oncology Center of Excellence Deputy Director Paul Kluetz November 15, 3:30-4:30 PM ET; Director of the Office of Tissues and Advanced Therapies at CBER Wilson Bryan, MD December 6 at 10 a.m.; Director of the Center for Food Safety and Advanced Nutrition, Susan Mayne December 14 at 2 p.m.
Analysis and Commentary - More Q&As on the Status of Appropriations and the Nomination of a New FDA Commissioner
Alliance Webinar At 3 P.M. Today. Still Time to Sign Up. The Alliance will be hosting a webinar this afternoon with Dr. William Slikker, Director of the FDA’s National Center for Toxicological Research (NCTR). He will discuss emerging priorities, trends and opportunities in their important work that spans biomarker development, nanotechnology, AI, neurobiology, gene therapy, and informatics. To RSVP, please click here. For this event, non-members are invited and should sign-up using the registration portal.
NCTR conducts scientific research to generate data for FDA decision-making and develops and supports innovative tools and approaches that FDA uses to protect and promote individual and public health. Every one of FDA’s product centers (food, animals, and medical products) rely heavily on the work done by NCTR in innovative areas of science.
In FY 21, NCTR had a budget of $67 million and a staff of 276. The President’s FY 22 budget request seeks a $10 million increase in the NCTR budget, reflecting its growing importance. NCTR celebrated its 50th anniversary on August 11, 2021, which is covered in FDA Voices: "FDA’s National Center for Toxicological Research Celebrates Half a Century of Cutting-Edge Research."
Come listen to Dr. Slikker. We are certain you will hear something new that is relevant to your organization. Note that we will be hearing from FDA’s Chief Scientist at a webinar later this year.
A Funding Reprieve Via CR, but Challenges Ahead. The Congress passed a CR to fund federal discretionary programs through December 3. While far better than a shutdown, this does limit FDA to spending monies at the same level as FY 21. It also limits the initiation of some new programs. Rarely mentioned is that a CR wreaks havoc with budget and program planning that the agency hoped to have available because of proposed new funds in the House and Senate bills.
By now, House and Senate Appropriations committee staff have usually reached informal agreement on funding levels for most programs. However, the bills cannot be finalized until total spending levels have been agreed upon, as well as the portion of the total to be allocated to each subcommittee. In other words, Congress could finish most appropriations bills in a few weeks but cannot do so until a budget agreement is in place.
Next Steps in the Executive Branch’s Shaping of Possible ARPA-H: The White House Office of Science and Technology Policy (OSTP) and NIH are hosting another ARPA-H listening session on October 20 at 2:30 p.m. ET. It will focus on key themes from the previous fifteen sessions, as well as how ARPA-H can engage most effectively with stakeholders. Submit your comments and questions to ARPAHcomments@nih.gov prior to the session, and/or register to attend.
Analysis and Commentary. This week’s column (below) answers three questions that we received this week. The first examines the impact of other legislation on the likely pace of Congressional consideration of a full year funding bill. The other questions discuss the status of efforts to identify the next Commissioner and the steps once someone is nominated.
Upcoming Alliance Webinars. We continue to invite FDA leadership to address the Alliance membership and media.
NCTR Director William Slikker is scheduled for October 15, 3:00-4:00 PM ET. The lead story (above) explains why you should sign up to listen to Dr. Slikker and find out more about NCTR. The link to sign up is here.
Oncology Center of Excellence Deputy Director Paul Kluetz is scheduled for November 15, 3:30-4:30 PM ET. The FDA Oncology Center of Excellence leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, devices, and diagnostics. The Center helps expedite development of medical products for oncologic and hematologic malignancies and supports an integrated approach to their clinical evaluation. Alliance members and media can register here.
Director of the Office of Tissues and Advanced Therapies at CBER Wilson Bryan, MD is scheduled for December 6 at 10 a.m. His office is the front-line in the development of gene therapies.
Director of the Center for Food Safety and Advanced Nutrition, Susan Mayne is scheduled for December 14 at 2 p.m. She will be discussing FDA’s nutrition programs and major initiatives in that area.
Today’s meeting with Dr. Slikker is open to non-members (sign-up here) For the other events, non-members wishing to participate should contact Alliance Executive Director Steven Grossman at: sgrossman@strengthenfda.org.