SUPPLEMENTARY INFORMATION:

I. Introduction

The authority for MDUFA (Pub. L. 110-85) expires September 30, 2012. Without new legislation to reauthorize the program, FDA will no longer be able to collect user fees to fund the medical device program. Section 738A(b)(1) (21 U.S.C. 379j-1(b)(1)) of the FD&C Act requires that FDA consult with a range of groups in developing recommendations for the next MDUFA program, including scientific and academic experts, health care professionals, and representatives from patient and consumer advocacy groups. FDA initiated this process of consultation on September 14, 2010, by ( printed page 77648) holding a public meeting where stakeholders and other members of the public were given an opportunity to present their views on reauthorization (75 FR 49502, August 13, 2010). This meeting and written comments submitted to the docket have provided critical input as FDA prepares for reauthorization discussions. Section 738A(b)(3) of the FD&C Act further requires that FDA meet with patient and consumer advocacy groups at least once every month during negotiations with the regulated industry to continue discussions of their views on the reauthorization, and their suggestions for changes to the MDUFA program.

FDA is issuing this Federal Register notice to request that patient and consumer advocacy groups notify FDA of their intent to participate in periodic consultation meetings on reauthorization of MDUFA. FDA believes that consistent 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 regularly and preparing for the discussions as needed. Patient and consumer advocacy groups who identify themselves through this notice will be included in all future patient and consumer advocacy group meetings while FDA negotiates with the regulated industry. If a representative of a patient and consumer advocacy group decides to participate in these monthly meetings at a later time, they may still participate in remaining monthly meetings by notifying FDA ( seeADDRESSES ). These meetings will satisfy the requirement in section 738A(b)(3) of the FD&C Act.

II. Additional Information on MDUFA

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

• Information on the September 2010 public meeting on MDUFA Reauthorization, theFederal Register notice announcing the meeting, and the transcript of the meeting are available at http://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​ucm218250.htm.
• FDA created a Webinar on the Medical Device User Fee program, medical device development, and FDA's medical device review in MDUFA. These presentations are available athttp://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​ucm218250.htm.
• KeyFederal Register documents, MDUFA-related guidances, legislation, performance reports, and financial reports and plans are posted at http://www.fda.gov/​MDUFA.
• 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 Patient and Consumer Advocacy Group Consultation Meetings

If you intend to participate in continued periodic patient and consumer advocacy group consultation meetings regarding MDUFA Reauthorization, please provide notification by e-mail to MDUFAReauthorization@fda.hhs.gov by January 6, 2011. Your e-mail should contain complete contact information, including name, title, affiliation, address, e-mail address, telephone number, and notice of any special accommodations required because of disability.

Representatives of patient and consumer advocacy groups will receive confirmation and additional information about the first meeting once FDA receives their notification.