
[Federal Register Volume 75, Number 238 (Monday, December 13, 2010)]
[Notices]
[Pages 77647-77648]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0389]


Medical Device User Fee Program; Meetings on Reauthorization; 
Request for Notification of Patient and Consumer Advocacy Group 
Intention to Participate

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for notification of participation.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this notice 
to request that patient and consumer advocacy groups notify FDA of 
their intent to participate in periodic consultation meetings on 
reauthorization of the Medical Device User Fee Amendments of 2007 
(MDUFA) (the Food and Drug Administration Amendments Act of 2007). The 
statutory authority for MDUFA expires September 30, 2012. At that time, 
new legislation will be required for FDA to continue collecting user 
fees for the medical device program. The Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) requires that FDA consult with a range of 
stakeholders in developing recommendations for the next MDUFA program. 
The FD&C Act also requires that FDA hold continued discussions with 
representatives of 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 patient and 
consumer advocacy group representation.

DATES: Submit notification of intention to participate by January 6, 
2011. The first patient and consumer advocacy group meeting will be 
held on January 13, 2011, from 9 a.m. to 11 a.m. Meetings will continue 
at least monthly during reauthorization negotiations with the regulated 
industry.

ADDRESSES: Submit notification of intention to participate in monthly 
patient and consumer advocacy group meetings by e-mail to 
MDUFAReauthorization@fda.hhs.gov. The first meeting will be held at the 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 
1503 B and C, Silver Spring, MD 20993-0002.

FOR FURTHER INFORMATION CONTACT: Cindy Garris, Food and Drug 
Administration, Center for Devices and Radiological Health 10903 New 
Hampshire Ave., Bldg. 66, rm. 4610, Silver Spring, MD 20993-0002, 301-
796-5861, FAX: 301-847-8149.

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

[[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 (see ADDRESSES). 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, the Federal 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 at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm218250.htm.
     Key Federal 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.

    Dated: December 8, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-31160 Filed 12-10-10; 8:45 am]
BILLING CODE 4160-01-P


