90 FR 121 pgs. 27323-27324 - Generic Drug User Fees; Consultation Meetings on Reauthorization of Generic Drug User Fee Amendments for Fiscal Years 2028-2032; Request for Notification of Intention to Participate
Type: NOTICEVolume: 90Number: 121Pages: 27323 - 27324
Pages: 27323, 27324Docket number: [Docket No. FDA-2025-N-1623]
FR document: [FR Doc. 2025-11769 Filed 6-25-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1623]
Generic Drug User Fees; Consultation Meetings on Reauthorization of Generic Drug User Fee Amendments for Fiscal Years 2028-2032; Request for Notification of Intention to Participate
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice; request for notification of participation.
SUMMARY:
[top] The Food and Drug Administration (FDA or Agency) is issuing this notice to request that interested parties, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for Fiscal Years (FYs) 2028-2032. At the end of September 2027, new legislation will be required for FDA to continue collecting
DATES:
Submit notification of intention to participate in these series of meetings by September 4, 2025. Meetings will be held monthly throughout the duration of negotiations with regulated industry, and it is anticipated that they will commence in the Fall of 2025. See the SUPPLEMENTARY INFORMATION section for registration date and information.
ADDRESSES:
Submit notification of intention to participate in monthly consultation meetings by email to GDUFAReauthorization@fda.hhs.gov. The meetings will be held in person at the FDA campus in White Oak, MD: 10903 New Hampshire Ave., Silver Spring, MD 20993 and virtually using the Microsoft Teams platform.
FOR FURTHER INFORMATION CONTACT:
Dat Doan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3334, Silver Spring, MD 20993-0002, 240-402-8926, GDUFAReauthorization@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is requesting that interested parties, including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts, notify the Agency of their intent to participate in periodic consultation meetings on the reauthorization of GDUFA. GDUFA authorizes FDA to collect user fees from the regulated industry for the current program (GDUFA III). At the end of September 2027, new legislation will be required for FDA to continue collecting user fees for subsequent fiscal years for the generic drug program. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund human generic drug activities. Section 744C(f)(1) (21 U.S.C. 379j-43(f)(1)) of the FD&C Act requires that FDA consult with a range of interested parties in developing recommendations for the next GDUFA program, including representatives from patient and consumer groups, health care professionals, and scientific and academic experts. FDA will initiate this process by holding a public meeting on July 11, 2025, at which interested parties and other members of the public will be given an opportunity to present their views on reauthorization (90 FR 21313, May 19, 2025). Section 744C(f)(3) (21 U.S.C. 379j-43(f)(3)) of the FD&C Act further requires that FDA continue meeting with these interested parties at least once every month during negotiations with the regulated industry to continue discussions of views from interested parties on the reauthorization. It is anticipated that these monthly consultation meetings will commence in the Fall of 2025.
FDA is issuing this Federal Register notice to request that interested representatives from patient and consumer advocacy groups, health care professional associations, as well as scientific and academic experts notify FDA of their intent to participate in periodic consultation meetings on GDUFA reauthorization. FDA believes that consistent representation by interested parties at these meetings will be important to ensure progress in these discussions. If you wish to participate in the consultation meetings, please designate one or more representatives from your organization who will commit to attending these meetings and preparing for the discussions, as needed. Interested parties who identify themselves through this notice will be included in all discussions with interested parties during the period that FDA negotiates with the regulated industry. Interested parties who decide to participate in these monthly meetings at a later time may still participate in remaining monthly meetings by notifying FDA (see ADDRESSES ). These discussions with interested parties will satisfy the periodic consultation requirement in section 744C(f)(3) (21 U.S.C. 379j-43(f)(3)) of the FD&C Act.
II. Notification of Intent To Participate in Periodic Consultation Meetings
If you intend to participate in continued periodic consultation meetings regarding GDUFA reauthorization, please provide notification by email to GDUFAReauthorization@fda.hhs.gov by September 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. Interested parties will receive confirmation and additional information about the first periodic consultation meeting after FDA receives this notification. Information concerning GDUFA, including the GDUFA III Commitment Letter, key Federal Register documents, GDUFA-related guidances, performance reports, and financial reports may be found on the FDA website at https://www.fda.gov/gdufa.
Dated: June 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11769 Filed 6-25-25; 8:45 am]
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