Document ID: FDA-2010-N-0128-0027
Agency: fda
Document Type: Notice
Title: Prescription Drug User Fee Act; Reauthorization; Request for Notification of Stakeholder Intention Participation
Posted Date: 2010-06-08T04:00Z

[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Notices]               
[Page 32483-32484]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn10-108]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0128]

 
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.

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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 PDUFAReauthorization@fda.hhs.gov. 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: 301-847-8443.

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

[[Page 32484]]

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 PDUFAReauthorization@fda.hhs.gov 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.
[FR Doc. 2010-13671 Filed 6-7-10; 8:45 am]
BILLING CODE 4160-01-S