2010-13671. Prescription Drug User Fee Act; Meetings on 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) is issuing this notice to request that public stakeholders—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 reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2012. 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 (the act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these discussions by establishing consistent stakeholder representation.

DATES:

Submit notification of intention to participate by June 25, 2010. The first stakeholder meeting will be held on July 1, 2010, from 9 a.m. to 11 a.m. Stakeholder discussions will continue at least monthly during reauthorization negotiations with the regulated industry.

ADDRESSES:

Submit notification of intention to participate in monthly stakeholder meetings by e-mail to [e-mail]. The first stakeholder meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, rm. 1503C, Silver Spring, MD 20993.

FOR FURTHER INFORMATION CONTACT:

Patrick Frey, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, rm. 1174, Silver Spring, MD 20993, 301-796-3844, FAX: [phone].

SUPPLEMENTARY INFORMATION:

I. Introduction

The authority for PDUFA expires in September 2012. Without new legislation to reauthorize the program, FDA will no longer be able to collect user fees to fund the human drug review process. Section 736B(d)(1) (21 U.S.C. 379h-2(d)(1)) of the act requires that FDA consult with a range of groups in developing recommendations for the next PDUFA program, including scientific and academic experts, health care professionals, and representatives from patient and consumer groups. FDA initiated this process of consultation on April 12, 2010, by holding a public meeting where stakeholders and other members of the public were given an opportunity to present their views on reauthorization (75 FR 12555, March 16, 2010). This meeting and written comments submitted to the docket have provided critical input as the Agency prepares for reauthorization discussions. Section 736B(d)(3) of the 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 their views on the reauthorization, including suggested changes to the PDUFA program.

FDA is issuing this Federal Register notice to request that stakeholders—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 reauthorization of PDUFA. FDA believes that consistent stakeholder representation at these meetings will be important to ensuring progress in these discussions. If you wish to participate in this part of the reauthorization process, please designate one or more representatives from your organization who will commit to attending these meetings and preparing for the discussions as needed. Stakeholders who identify themselves through this notice will be included in all future stakeholder discussions while FDA negotiates with the regulated industry. If a stakeholder decides to participate in these monthly meetings at a later time, they may still participate in remaining monthly meetings by notifying FDA (see ADDRESSES). These stakeholder discussions will satisfy the requirement in section 736B(d)(3) of the act.

II. Additional Information on PDUFA

There are several sources of information on FDA's Web site that may serve as useful resources for stakeholders participating in the periodic consultation meetings:

• Information on the April 2010 public meeting on PDUFA Reauthorization, the Federal Register notice announcing the meeting, and the transcript of the meeting are available at http://www.fda.gov/​ForIndustry/​UserFees/​PrescriptionDrugUserFee/​ucm117890.htm. The slide presentations from the meeting can be found at http://www.regulations.gov using Docket No. FDA-2010-N-0128.
• FDA created a webinar on the PDUFA program, drug development, and FDA's drug review in PDUFA IV. These presentations are available at http://www.fda.gov/​ForIndustry/​UserFees/​PrescriptionDrugUserFee/​ucm207597.htm.
• Key Federal Register documents, PDUFA-related guidances, legislation, performance reports, and financial reports and plans are posted at http://www.fda.gov/​ForIndustry/​UserFees/​PrescriptionDrugUserFee/​default.htm.
• The Food and Drug Administration Amendments Act of 2007 (FDAAA)-specific information is available at: http://www.fda.gov/​RegulatoryInformation/​Legislation/​FederalFoodDrugandCosmeticActFDCAct/​SignificantAmendmentstotheFDCAct/​FoodandDrugAdministrationAmendmentsActof2007/​default.htm

III. Notification of Intent to Participate in Periodic Consultation Meetings

If you intend to participate in continued periodic stakeholder consultation meetings regarding PDUFA Reauthorization, please provide notification by e-mail to [e-mail] by June 25, 2010. Your e-mail should contain complete contact information, including name, title, affiliation, address, e-mail address, phone number, and notice of any special accommodations required because of disability. Stakeholders will receive confirmation and additional information about the first meeting once FDA receives their notification.

Dated: June 2, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.