CR and User Fees Passed; New OTAT name; Upcoming Webinars
FY 23 Continuing Resolution (CR) Through December 16 Approved.
User Fee Extension Included the CR.
Congress in Recess Until After the Election.
FDA’s Cell and Gene Therapy Division, OTAT, Gets New Name and Designation.
Upcoming Alliance Webinars: October 20 at 1:30 p.m. “Digital Health and Cyber Security" with Dr. Suzanne Schwartz, Directors of CDRH’s Office of Strategic Partnerships & Technology Innovation (OST).
This week’sAnalysis and Commentarycovers the Alliance’s webinar on FDA and One Health Tuesday, September 27, 2022, which featured Dr. Steven Solomon (CVM Director) and the new Chief Scientist, Dr. Namandjé Bumpus.
FY 23 Continuing Resolution (CR) Through December 16 Approved –Following a 72-25 vote in the Senate and a 230-201 vote in the House to approve H.R.6833, the legislative vehicle for the CR, the measure now goes to the White House for the President’s signature. Senate approval came after Senator Manchin set aside efforts to establish two-year targets for permitting provisions under the National Environmental Policy Act (NEPA).
The CR does not provide increased resources for FDA As we have reported in previous Friday Updates, FDA’s resources are capped under a CR, limited to the level of funds available in the prior fiscal year. There are also restrictions on the start of new programs, although there can be ways to show that some modest effort in the prior fiscal year is a predicate for new activities under the CR.
User Fee Extension Included the CR.Division Fof the CR reauthorizes FDA user fees for five years, and to add this extension to the CR. The linked information is taken from the section by section analysis released by the Senate Appropriations Committee.
House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) in a press release said policy areas that he wanted included in the CR were not included. He said that all four corners are committed to returning to the negotiating table ahead of the December government funding deadline to revisit these policy issues.
Congress in Recess Until After the Election –With the completion of yesterday’s business, The Senate stands adjourned for pro forma sessions only. It will next convene at 11:00 a.m. on Friday, October 11 for consideration of the National Defense Authorization Act. It will next return at 3:00 pm Monday, November 14th. When the House completes its session this week it will be in recess until November 14.
CBER's Cell and Gene Therapy Division, OTAT, Gets New Name and Designation.On Tuesday, September 27, 2022, the FDAannouncedthat its Office of Tissues and Advanced Therapies (OTAT) has is now a “super office” with a new title: the Office of Therapeutic Products (OTP). This comes as the office has started reviewing a surge of Investigational New Drug (IND) applications for cell and gene therapy products, bolstered by the new hiring authority under the PDUFA VII Commitment letter. It’s clear that the name change and new designation, including more authority and supervisory positions, will be critical for CBER’s modernization efforts. More word on modernization, including a new multi-year “modernization roadmap”, is expected by today.
October 20 at 1:30 p.m. - “Digital Health and Cyber Security" with Dr. Suzanne Schwartz, Directors of CDRH’s Office of Strategic Partnerships & Technology Innovation (OST). REGISTER HERE.
The Center for Devices and Radiological Health's Office of Strategic Partnerships and Technological Innovation is a key leader for all scientific collaborative and emerging technology. The Office is an innovative leader in digital collaborates with patient organizations, healthcare professional organizations, industry, scientific and other external organizations to address unmet public health needs with emerging technology. On top of their partnership goals, the Office also manages CDRH's medical device cybersecurity, software, and digital health standards. We look forward to talking with Dr. Schwartz about her experience and needs in this innovative area.