SUPPLEMENTARY INFORMATION:

I. Background

FDA is requesting that public stakeholders—including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts—notify the Agency of their intent to participate in periodic stakeholder consultation meetings on the reauthorization of PDUFA. PDUFA authorizes FDA to collect user fees from the regulated industry for the process for the review of human drugs. The authorization for the current program (PDUFA VI) expires in September 2022. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the human drug review process.

Section 736B(f)(1) of the FD&C Act (21 U.S.C. 379h-2(f)(1)) requires that FDA consult with a range of stakeholders, including representatives from patient and consumer groups, healthcare professionals, and scientific and academic experts, in developing recommendations for the next PDUFA program. FDA will initiate the reauthorization process by holding a public meeting on July 23, 2020, where stakeholders and other members of the public will be given an opportunity to present their views on the reauthorization. The FD&C Act further requires that FDA continue meeting with these stakeholders at least once every month during negotiations with the regulated industry to continue discussions of stakeholder views on the reauthorization. It is anticipated that these monthly stakeholder consultation meetings will commence in September 2020.

FDA is issuing this Federal Register notice to request that stakeholder representatives from patient and consumer groups, healthcare professional associations, as well as scientific and academic experts, notify FDA of their intent to participate in the periodic stakeholder consultation meetings on PDUFA reauthorization. FDA believes that consistent stakeholder representation at these meetings will be important to ensure progress in these discussions. If you wish to participate in the stakeholder consultation meetings, please designate one or more representatives from your organization who will commit to attending these meetings and preparing for the discussions. Stakeholders who identify themselves through this notice will be included in all stakeholder consultation discussions while FDA ( printed page 40663) negotiates with the regulated industry. If a stakeholder decides to participate in these monthly meetings at a later time, that stakeholder may join the remaining monthly stakeholder consultation meetings after notifying FDA of this intention (see ADDRESSES ). These stakeholder discussions will satisfy the consultation requirement in section 736B(f)(3) of the FD&C Act.

II. Notification of Intent To Participate in Periodic Stakeholder Consultation Meetings

If you intend to participate in continued periodic stakeholder consultation meetings regarding PDUFA reauthorization, please provide notification by email to PDUFAReauthorization@fda.hhs.gov by August 17, 2020. Your email should contain complete contact information, including name, title, affiliation, address, email address, phone number, and notice of any special accommodations required because of disability. Stakeholders will receive confirmation and additional information about the first meeting after FDA receives this notification.

85 FR 40662