FY 22 Continuing Resolution (CR) up next; best scenario for FDA; FDA aided by Reconciliation if it passes
Top-Line:
FY 22 Appropriations update: Continuing Resolution (CR) up next.
FY 22 Appropriations: What would be best for FDA?
House Energy and Commerce Committee adopts Reconciliation package.
FDA utilizes public contest to generate affordable approaches to food traceability.
Upcoming Alliance Webinars - FDA Chief Scientist RADM Denise Hinton and NCTR Director Dr. William Slikker October 15, 3:00-4:00 PM ET.
FY 22 Appropriations Update: Continuing Resolution (CR) Up Next. With the fiscal year (FY 21) ending in just two weeks, Congress is expected to give itself additional time to reach agreements on FY 22 funding. The CR being put together by Congress is expected to continue funding the government through December 3 or 10 (probably the latter). Next Monday (September 20), the House Rules Committee will meet and, among other things, set the text and amendments that can be considered when the CR comes to the House floor. Presumably, the House would consider the CR mid-week next week and that would give the Senate about a week to act. Today’s Analysis and Commentary looks at what happens if Congress does not act before October 1.
FY 22 Appropriations: What Would Be Best for FDA? Operating under a Continuing Resolution is less than ideal for FDA. The agency is only able to spend a prorated amount of what the agency received in FY 21. In addition, a CR comes with limitations on the initiation of new programs. If the CR extends for 10 weeks (until December 10), that will represent one-fifth of the fiscal year. FDA will be able to recoup the monies when the Ag/FDA appropriations bill becomes law. However, there is always the risk that Congress will continue to deadlock and that a full-year CR is adopted (limiting the agency to its FY 21 levels for the full year).
The House-passed and Senate Committee-passed numbers for FDA for FY 22 (+$257 million/+$200 million) should net a substantial increase for the agency. So, we are eager for the appropriations process to be completed soon. On the other hand, the worst-case scenario for FDA would be a government shutdown. We had considered the likelihood to be near zero, but considering the debt ceiling and reconciliation impasses, we have re-assessed to “highly unlikely but not implausible.”
House Energy and Commerce Committee Adopts Reconciliation Package. This week, the House E&C marked up a reconciliation package that will be combined with similar packages from other committees to form legislation that the House is slated to vote on next week. Notably, the package includes substantial monies for pandemic preparedness and medical innovation:
Section 31025 provides $8,000,000,000 in funding to the Assistant Secretary for Preparedness and Response, to prepare for, and respond to, public health emergencies, including shoring up the Strategic National Stockpile, strengthening our supply chains, supporting domestic and global manufacturing of vaccines, bolstering biosecurity, and investing in therapeutics, among other activities.
Sec. 31031 provides $3,000,000,000 to establish the Advanced Research Projects Agency for Health (ARPA-H). Funding for ARPA-H seeks to make pivotal investments in breakthrough technologies and broadly applicable platforms, capabilities, resources, and solutions that have the potential to transform important areas of medicine and health that cannot readily be accomplished through traditional biomedical research or commercial activity
Today’s Analysis and Commentary looks further into ARPA-H and the potential for an FDA role.
FDA Utilizes Public Contest to Generate Affordable Approaches to Food Traceability. As reported by Food Safety News, FDA received submissions from 90 teams in response to its “Low- or No-Cost Tech-Enabled Traceability Challenge.” The goal is to help achieve end-to-end traceability – from source to table – throughout the food safety system. This week FDA announced the twelve finalist candidates and scheduled a webinar for each to present their solutions and take questions. The webinar will be from 11 a.m. to 1 p.m. EDT on Sept. 28.
Upcoming Alliance Webinars. We continue to invite FDA leadership to address the Alliance membership and media. We have now scheduled FDA Chief Scientist Denise Hinton and NCTR Director William Slikker for October 15, 3:00-4:00 PM ET. The Office of the Chief Scientist at FDA is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The National Center for Toxicology Research (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.
Alliance members and media can register here. Non-members wishing to participate should contact Alliance Executive Director Steven Grossman at: sgrossman@strengthenfda.org.