Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate, 19724 [2025-08209]

Download as PDF 19724 Federal Register / Vol. 90, No. 89 / Friday, May 9, 2025 / Notices II. Request for Comments FDA is soliciting comments on the ‘‘Product Quality Information Request Communications Assessment: Final Report’’ from interested parties. We request feedback on: (1) the assessment findings and recommendations, (2) whether certain recommendations are more desirable than others, and (3) other actions FDA and applicants should consider and why. III. Electronic Access Persons with access to the internet may obtain the report at https:// www.fda.gov/industry/prescriptiondrug-user-fee-amendments/pdufa-viiassessment-fda-and-sponsorcommunications-through-productquality-information-requests. Dated: May 6, 2025. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025–08208 Filed 5–8–25; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2025–N–0834] Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate AGENCY: Food and Drug Administration, HHS. Notice; request for notification of participation. ACTION: The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders—including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts—notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:11 May 08, 2025 Jkt 265001 every month) with patient and consumer advocacy groups during FDA’s negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation. DATES: Submit notification of intention to participate in these series of meetings by August 4, 2025. Stakeholder meetings will be held monthly. It is anticipated that they will commence in September 2025. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: Submit notification of intention to participate in monthly stakeholder meetings by email to PDUFAReauthorization@fda.hhs.gov. The meetings will be held in person at the FDA White Oak campus, 10903 New Hampshire Ave., Silver Spring, MD 20993 and virtually using the Microsoft Teams platform. FOR FURTHER INFORMATION CONTACT: Andrew Kish, Center for Drug Evaluation and Research, Food and Drug Administration, 301–796–5215, Andrew.Kish@fda.hhs.gov. 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 VII) expires in September 2027. 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 14, 2025, 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 9990 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 2025. FDA is issuing this 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 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 4, 2025. 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. Dated: May 6, 2025. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025–08209 Filed 5–8–25; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\09MYN1.SGM 09MYN1

Agencies

[Federal Register Volume 90, Number 89 (Friday, May 9, 2025)]
[Notices]
[Page 19724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08209]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-0834]


Prescription Drug User Fee Act; Stakeholder Consultation Meetings 
on the Prescription Drug User Fee Act Reauthorization; Request for 
Notification of Stakeholder Intention To Participate

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for notification of participation.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing 
this notice to request that public stakeholders--including patient and 
consumer advocacy groups, healthcare professionals, and scientific and 
academic experts--notify FDA of their intent to participate in periodic 
consultation meetings on the reauthorization of the Prescription Drug 
User Fee Act (PDUFA). The statutory authority for PDUFA expires in 
September 2027. At that time, new legislation will be required for FDA 
to continue collecting user fees for the prescription drug program. The 
Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA 
consult with a range of stakeholders in developing recommendations for 
the next PDUFA program. The FD&C Act also requires that FDA hold 
discussions (at least every month) with patient and consumer advocacy 
groups during FDA's negotiations with the regulated industry. The 
purpose of this request for notification is to ensure continuity and 
progress in these monthly discussions by establishing consistent 
stakeholder representation.

DATES: Submit notification of intention to participate in these series 
of meetings by August 4, 2025. Stakeholder meetings will be held 
monthly. It is anticipated that they will commence in September 2025. 
See the SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: Submit notification of intention to participate in monthly 
stakeholder meetings by email to [email protected]. The 
meetings will be held in person at the FDA White Oak campus, 10903 New 
Hampshire Ave., Silver Spring, MD 20993 and virtually using the 
Microsoft Teams platform.

FOR FURTHER INFORMATION CONTACT: Andrew Kish, Center for Drug 
Evaluation and Research, Food and Drug Administration, 301-796-5215, 
[email protected].

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 VII) expires in September 
2027. 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 14, 2025, 
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 2025.
    FDA is issuing this 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 
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 [email protected] by August 4, 
2025. 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.

    Dated: May 6, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08209 Filed 5-8-25; 8:45 am]
BILLING CODE 4164-01-P

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